PI: Garrett, Patricia Title: Rapid Test for Recent HIV Infection

Received: 09/09/2013 FOA: PA10-123 Council: 01/2014

Competition ID: ADOBE-FORMS-B1 FOA Title: NIAID ADVANCED TECHNOLOGY SBIR (NIAID-AT-SBIR [R43/R44])

2 R44 AI098567-03 Dual: Accession Number: 3620271

IPF: 2755701 Organization: IMMUNETICS, INC.

Former Number: Department:

IRG/SRG: ZRG1 AARR-E (81)B AIDS: Y Expedited: Y

Subtotal Direct Costs Animals: N New Investigator: N

(excludes consortium F&A) Humans: Y Early Stage Investigator: N

Year 3: Clinical Trial: N

Year 4: Current HS Code: 30

Year 5: HESC: N

Senior/Key Personnel: Organization: Role Category:

Patricia Garrett Immunetics, Inc. PD/PI 

Andrew Levin Immunetics, Inc. Other (Specify)-Scientific Director

Victor Kovalenko Immeuntics, Inc Other (Specify)-Principal Scientist

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State Application Identifier

Applicant Identifier

1. * TYPE OF SUBMISSION 4. a. Federal Identifier

5. APPLICANT INFORMATION * Organizational DUNS:

* Legal Name:

Department: Division:

* Street1:

Street2:

* City:

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* Country: * ZIP / Postal Code:

Person to be contacted on matters involving this application

* First Name: Middle Name:

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6. * EMPLOYER IDENTIFICATION (EIN) or (TIN):

7. * TYPE OF APPLICANT:

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Small Business Organization Type Women Owned Socially and Economically Disadvantaged

If Revision, mark appropriate box(es).

9. * NAME OF FEDERAL AGENCY:

A. Increase Award B. Decrease Award C. Increase Duration D. Decrease Duration

E. Other (specify):

10. CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:

* Is this application being submitted to other agencies?

TITLE:

11. * DESCRIPTIVE TITLE OF APPLICANT'S PROJECT:

2. DATE SUBMITTED

3. DATE RECEIVED BY STATE APPLICATION FOR FEDERAL ASSISTANCE

SF 424 (R&R) 

County / Parish:

Province:

Prefix:

What other Agencies?

Pre-application Application Changed/Corrected Application

Immunetics, Inc.

Dr. Andrew E.

Levin

Rapid Test for Recent HIV Infection

Yes No

USA: UNITED STATES

MA: Massachusetts

R: Small Business

National Institutes of Health

New Resubmission

Renewal Continuation Revision

8. * TYPE OF APPLICATION:

OMB Number: 4040-0001 

Expiration Date: 06/30/2011 

b. Agency Routing Identifier

12. PROPOSED PROJECT:

* Start Date * Ending Date

07/01/2014 06/30/2017

* 13. CONGRESSIONAL DISTRICT OF APPLICANT

MA-008

14. PROJECT DIRECTOR/PRINCIPAL INVESTIGATOR CONTACT INFORMATION

* First Name: Middle Name:

* Last Name: Suffix:

Position/Title:

* Organization Name:

Department: Division:

* Street1:

Street2:

* City:

* Country: * ZIP / Postal Code:

* Phone Number: Fax Number:

* Email:

* State:

County / Parish:

Province:

Prefix:

Garrett

Dr. Patricia

-

Principle Scientist

Immunetics, Inc.

MA: Massachusetts

USA: UNITED STATES

	


 		

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SF 424 (R&R) APPLICATION FOR FEDERAL ASSISTANCE Page 2

15. ESTIMATED PROJECT FUNDING 16. * IS APPLICATION SUBJECT TO REVIEW BY STATE EXECUTIVE 

ORDER 12372 PROCESS?

a. YES a. Total Federal Funds Requested

17. By signing this application, I certify (1) to the statements contained in the list of certifications* and (2) that the statements herein are 

true, complete and accurate to the best of my knowledge. I also provide the required assurances * and agree to comply with any resulting 

terms if I accept an award. I am aware that any false, fictitious. or fraudulent statements or claims may subject me to criminal, civil, or 

administrative penalities. (U.S. Code, Title 18, Section 1001)

19. Authorized Representative

* First Name: Middle Name:

* Last Name: Suffix:

* Position/Title:

* Organization:

Department: Division:

* Street1:

Street2:

* City:

* State:

* Country: * ZIP / Postal Code:

* Phone Number: Fax Number:

* Email:

* Signature of Authorized Representative * Date Signed

20. Pre-application

* The list of certifications and assurances, or an Internet site where you may obtain this list, is contained in the announcement or agency specific instructions.

County / Parish:

c. Total Federal & Non-Federal Funds

18. SFLLL or other Explanatory Documentation

Province:

b. Total Non-Federal Funds

Prefix:

0.00

0.00

* I agree

Dr. Andrew E.

Levin

President and Chief Executive Officer

Immunetics, Inc.

MA: Massachusetts

USA: UNITED STATES

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DATE:

THIS PREAPPLICATION/APPLICATION WAS MADE 

AVAILABLE TO THE STATE EXECUTIVE ORDER 12372 

PROCESS FOR REVIEW ON:

PROGRAM HAS NOT BEEN SELECTED BY STATE FOR 

REVIEW

PROGRAM IS NOT COVERED BY E.O. 12372; OR

Andrew Levin 09/09/2013

b. NO

d. Estimated Program Income

	


 		

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424 R&R and PHS-398 Specific

Table Of Contents Page Numbers

SF 424 R&R Face Page------------------------------------------------------------------------------------------ 1

Table of Contents--------------------------------------------------------------------------------------------- 3

Performance Sites--------------------------------------------------------------------------------------------- 4

Research & Related Other Project Information------------------------------------------------------------------ 6

 Project Summary/Abstract (Description)---------------------------------------- 7

 Public Health Relevance Statement (Narrative attachment)---------------------------------------- 8

 Facilities & Other Resources---------------------------------------- 9

 Other Attachments---------------------------------------- 16

 Sbc 000001387---------------------------------------- 16

Research & Related Senior/Key Person-------------------------------------------------------------------------- 17

 Biographical Sketches for each listed Senior/Key Person---------------------------------------- 22

Research & Related Budget - Year 1---------------------------------------------------------------------------- 52

Research & Related Budget - Year 2---------------------------------------------------------------------------- 55

Research & Related Budget - Year 3---------------------------------------------------------------------------- 58

 Budget Justification---------------------------------------- 61

Research & Related Budget - Cumulative Budget----------------------------------------------------------------- 64

Research & Related Budget - Consortium Budget (Subaward 1)---------------------------------------------------- 65

Research & Related Budget - Consortium Budget (Subaward 2)---------------------------------------------------- 76

Research & Related Budget - Consortium Budget (Subaward 3)---------------------------------------------------- 87

SBIR/STTR Information----------------------------------------------------------------------------------------- 99

 Commercialization Plan---------------------------------------- 101

 Prior SBIR Phase II Awards---------------------------------------- 110

PHS 398 Specific Cover Page Supplement------------------------------------------------------------------------ 112

PHS 398 Specific Research Plan-------------------------------------------------------------------------------- 114

 Specific Aims---------------------------------------- 115

 Research Strategy---------------------------------------- 116

 Human Subjects Sections---------------------------------------- 128

 Protection of Human Subjects---------------------------------------- 128

 Women &Minorities---------------------------------------- 130

 Planned Enrollment Table---------------------------------------- 131

 Children---------------------------------------- 132

 Bibliography & References Cited---------------------------------------- 133

 Consortium/Contractual---------------------------------------- 134

 Letters of Support---------------------------------------- 138

 Resource Sharing Plan---------------------------------------- 147

PHS 398 Checklist--------------------------------------------------------------------------------------------- 148

Table of Contents Page 3

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
1. Are Human Subjects Involved?

IRB Approval Date:

Human Subject Assurance Number:

2. Are Vertebrate Animals Used?

IACUC Approval Date:

Animal Welfare Assurance Number:

4.b. If yes, please explain:

4.c. If this project has an actual or potential impact on the environment, has an exemption been authorized or an environmental assessment (EA) or 

 environmental impact statement (EIS) been performed?

4.d. If yes, please explain:

6. Does this project involve activities outside of the United States or partnerships with international collaborators?

6.b. Optional Explanation:

7. Project Summary/Abstract

11. Equipment

8. Project Narrative

12. Other Attachments

RESEARCH & RELATED Other Project Information

Is the IACUC review Pending?

If no, is the IRB review Pending?

2.a. If YES to Vertebrate Animals

3. Is proprietary/privileged information included in the application? 

4.a. Does this Project Have an Actual or Potential Impact - positive or negative - on the environment? 

6.a. If yes, identify countries:

9. Bibliography & References Cited

10. Facilities & Other Resources

Yes No

1.a. If YES to Human Subjects

Yes No

Yes No

If yes, check appropriate exemption number.

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

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Add Attachment Delete Attachment View Attachment

Add Attachment Delete Attachment View Attachment

Add Attachment Delete Attachment View Attachment

Add Attachments Delete Attachments View Attachments

Is the Project Exempt from Federal regulations?

5. Is the research performance site designated, or eligible to be designated, as a historic place? Yes No

5.a. If yes, please explain:

OMB Number: 4040-0001 

Expiration Date: 6/30/2016

1 2 3 4 5 6

	


 		

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Other Information Page 6

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Monitoring the HIV epidemic to understand rates and patterns of growth, as well as targeting intervention 

efforts to populations exhibiting high rates of HIV transmission, are wholly dependent on determining the 

frequency of new infections using an assay that discriminates recent from long-term HIV infection. However, 

very few HIV assays have been developed specifically to distinguish incidence from prevalence. An added

barrier has been the lack of an incidence assay for field work and resource-poor settings. Most HIV serologic 

assays are aimed at diagnostic use, while RNA assays have been used largely to determine viral load for 

clinical management purposes. Furthermore, HIV incidence testing currently requires access to well-equipped 

centralized laboratories capable of running the few sophisticated assays available for this purpose; these have 

been ELISAs requiring microplate handling and reading instrumentation, including the BED ELISA and the 

Vironostika detuned ELISA. Dependence on a central laboratory also implies the requirement for a system to 

transport serum specimens from where they have been collected to the laboratory, a separate and acute 

logistical challenge.

In this project, we propose to transform HIV serological incidence testing from ELISA methodology based on 

avidity and titer and requiring a laboratory with sophisticated infrastructure, to a field procedure using a simple, 

stable, and reliable rapid test. In Phase I, we have developed prototypes of a new, highly sensitive rapid test 

Project Description Page 7

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
To accurately monitor the HIV epidemic with respect to the rate of new infections, and to determine optimal 

interventions to prevent further transmission, a test that can identify recent infections is essential. Currently, 

such HIV incidence tests are few, mostly suboptimal in performance, and require a sophisticated laboratory to 

perform. We propose to develop the first rapid HIV incidence test than can be used in field conditions, without 

a laboratory, and will deliver results as or more accurate than the best laboratory tests now available. This test 

will put a powerful tool for identification of new HIV infections at the disposal of individuals and organizations 

responsible for monitoring and managing HIV prevention in the field.

Public Health Relevance Statement Page 8

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
FACILITIES AND RESOURCES

Immunetics, Inc.

Scientific environment:

Immunetics has developed effective capabilities and expertise for in vitro diagnostic assay development,

manufacture and commercialization over a more than 20 year period devoted to this field. The company 

has pioneered a number of diagnostic assays for infectious diseases including the C6 peptide Lyme ELISA 

which is the first FDA-approved Lyme test based on a synthetic peptide, the Anthrax PA QuickELISATM 

which is the first serologic test for anthrax approved by the FDA, and a variety of tests for esoteric 

pathogens including Babesia, Anaplasma, T. cruzi, T. solium and others. Immunetics was the first

company to develop a neonatal dried blood spot-based HIV Western Blot for public health surveillance 

purposes, which became a CDC protocol in use for over a decade. Immunetics is one of a small number of 

companies which has the know-how and experience to manufacture and market kits for clinical

diagnostics in a variety of resource-limited settings in Africa, Asia and Latin America. 

Clinical:

Immunetics does not have a clinical facility. 

Animal:

Immunetics does not maintain animal facilities.

Computer:

Immunetics has a networked, state-of-the-art PC-based computer system supported by a secure server with

password protection and including all peripherals, printers, scanners, data storage devices, etc. 

Office: 

Immunetics has an office area of 2,500 sf including all typical office services, computer stations and meeting 

facilities. Office support services including purchasing and accounting are available from staff, as included under 

indirect expense. 

Facilities Page 9

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
FACILITIES AND RESOURCES

Other:

Immunetics staff, including office and laboratory (R&D, manufacturing and regulatory personnel) are

available for additional support where needed. 

Major Equipment:

Immunetics’ laboratory contains multiple workstations set up for assay development with electrophoresis and 

blotting equipment, ELISA readers, a FluoStar fluorescence Microplate reader, Biotek automated ELISA 

washer, Microplate agitator, flow-through Microplate manifold, protein concentration devices, Misonix probe 

sonicator, Labconco Lyph- Lock 6 shelf lyophilizer with automatic capping, argon hood for vial filling, liquid 

nitrogen tank, Waters HPLC system, low-pressure liquid chromatography system, floor and benchtop 

centrifuges, vacuum pumps, pH meters, balances, incubators, shakers, a deionized water supply system, a 

spectrophotometer, refrigerators and -20°C freezers, -80°C freezer, a variety of pipetters and small

instruments. A walk-in cold room, chemical safety hood and four laminar flow biosafety cabinets are located 

Facilities Page 10

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
FACILITIES AND RESOURCES

 The 

company was started as an invention-based organization focused on development of sensitive colorimetric 

detection systems for rapid diagnostic tests and bioanalytical applications which use peroxidative enzymes as 

labels. In the six years since its inception, the company has developed many unique reagents for application in 

various membrane-based rapid tests and developed the concept for incorporation of a sensitive peroxidasebased detection system into a lateral flow format. The company staff is well experienced in the area of 

bioconjugation techniques, assay development and transfer of developed products to manufacturing. The 

company has performed several feasibility studies for application of the new technology to detection of 

antigens, disease markers, antibodies, and bacterial cells, which demonstrated the large potential of the new 

technology for development of highly sensitive rapid tests in various formats. The laboratory is well-equipped 

for development of membrane-based diagnostic tests and general immunochemistry work. 

Laboratory: 

 laboratory and office space (3,250 SF) in a business park with a separate 

entrance and security system. The laboratory is equipped for basic biochemistry and immunochemistry 

workoptimized for synthesis and analysis of conjugates, antigen and antibody characterization, and 

assay development. The laboratory is designed to have the nessesary utilities including power, water, 

pressurized airand additional air purification and humidity control equipment. The laboratory space can

accommodate 8-10 scientists. 

Clinical:

 does not have a clinical facility. 

Animal:

 does not maintain animal facilities.

Computer: 

has 11 networked PC-based computers supported by a secure server with password 

protection and including all peripherals, printers, scanners, data storage devices, etc. 

Office:

has an office area for eight scientists and management including typical office 

services, computer stations and meeting facilities. Additional resources include storage and receiving areas 

and a kitchen facility. 

Other: 

 staff are available for additional support where needed.

Major Equipment: 

The Company has a spectrophotometer, spectrophotometer/densitometer for membranes, microplate 

spectrophotometer, strip readers, HPLC and low pressure chromatography systems, water purification 

system, freeze dryer, plate washer, pH meters, conductimeter, balances, pumps, benchtop centrifuges, 

shakers, electrophoresis systems, dispensers for membranes (BioDot XYZ Dispensing system, CAMAG 

Linomat 4), automatic cutters for membranes (Kinematic Automation) , laminators, vacuum and convectional 

dryers, vacuum sealers, refrigerators/freezers, hoods, dehumidifiers, air purification systems, various 

accessories for enzyme immunoassays, drilling and cutting tools, air compressors, and photodocumentation 

systems. 

Facilities Page 11

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
FACILITIES AND RESOURCES

Scientific environment: 

is a full service developer and contract manufacturer of lateral flow assays and associated devices and 

electronics. We are ISO 9001:2008 and EN 13485 registered for development and production of assays, 

devices and electronics, and have a full range of manufacturing equipment for batch manufacture of lateral

flow assays. DCN assists clients in rapidly developing, manufacturing and commercializing point of care lateral 

flow, flow through, microfluidic and ELISA assays for any market segment. We develop using fluorescent, 

visual (colloidal gold / colored latex) and paramagnetic labels. High sensitivity, quantitative and reader-based 

tests are our specialty. 

 is the only OEM company in the rapid diagnostics market with the ability to contract develop entire point 

of care assay systems. We can design, develop, integrate, validate and transfer to manufacturing all aspects of 

a point of care assay system including the assay chemistry and biology, reagents, conjugates, strip design, 

cassettes, sample handling devices, and reader. We back up this capability with a broad network of partner 

companies in our Network of Affiliates and an on-staff group of highly experienced industry professionals that 

are available for consulting on any aspect of the development and commercialization of rapid diagnostics. We 

have developed products for markets as broad as clinical diagnostics, veterinary diagnostics, biowarfare, food 

science, microbiology, environmental health and safety, water quality, forensics, agriculture and consumer 

testing. 

As of March 2011 is both ISO 9001:2008 and ISO 13485 certified, and in March 2012 was also ISO 

13485 certified for Manufacturing. 

Primary Services: 

• Contract assay development

• Design and integration of cassettes, sample handling devices and strip readers 

• Optimization and production of latex, colloidal gold and protein conjugates

• Education and training in lateral flow and flow through assay technology 

• Consulting services

• Contract manufacturing 

• Sales of supporting products, including digital readers, assay materials, and critical reagents 

Laboratory: 

occupies an 8,000 sf suite in a business park. Of the 8,000 total sf, 3,000 sf area dedicated 

laboratory space housed in a class 10,000 capable clean-room. The laboratory is subdivided into three 

sections that can be closed off with doors. Laboratories are designed to have all the necessary utilities

including power, water, pressurized air, etc. Inside the laboratory space, we have laboratory benches and 

islands to accommodate 16-20 scientists. Recently added a 250 sf dry-room (15% relative humidity) to 

the facility. This temperature and humidity controlled room is used to assemble assay components that are 

sensitive to moisture, and to store materials that need a dry, desiccated environment. 

Clinical:

 does not have a clinical facility.

Animal:

 does not maintain animal facilities.

Office:

The office and laboratory suite has a reception area, several offices for the scientists and management, a 

conference room, a server room, a storage room, rest rooms and a dedicated lunch room. 

Facilities Page 12

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
FACILITIES AND RESOURCES

Major Equipment: 

has a well-equipped 3,000 sf laboratory with sufficient 

bench space to accommodate 16-20 scientists. We have typical small laboratory 

equipment including timers, pipets, rockers,rotators, shakers, mixers and vortexers. We 

also have continuously monitored refrigerators and freezers(including ultralow

temperatures) to store reagents, temperature sensitive raw materials, and samples. In 

addition, we have several incubators and ovens that are also continuously monitored. Larger 

equipment pieces that are housed in our laboratory include centrifuges, 

spectrophotometers, a microwell plate reader, a biological safety cabinet, a fume hood, a 

water purification system, and a lyophilizer. Equipment that dedicated to the production of 

lateral flow tests includes fluid-dispense systems, cutters, laminators and heat sealers. 

Recently we have added a 250 sf temperature-controlled dry-room (15% relative humidity) 

to assemble and store moisture-sensitive materials. All of our equipment has been

validated, is calibrated if needed, and is under a preventive maintenance program. 

Facilities Page 13

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
FACILITIES AND RESOURCES

Laboratory: 

has state of the art equipment 

to support research related to blood and blood product safety in the areas of molecular biology, 

immunology, virology, tissue culture, cell processing and epidemiology. staff has 8044 sq. 

ft. of labs (including a biosafety level 3 lab), and a 2896 square foot freezer room with capacity 

to store more than one million specimens. All equipment is shared among investigators.

 has several core laboratories that are available to all investigators on a shared access 

basis. Relevant to this project is our Core Immunology Laboratory (CIL). The CIL is a 

successful resource for accomplishing high throughput immunological analysis of specimens 

that are part of larger research objectives. The CIL provides expertise in cellular, antibody or 

antigen detection assays such as high throughput T cell response screening (ELISPOT), single 

or multiplex analyte analysis (ELISA or Luminex), and cell sorting and general flow cytometry 

facilities (FACS Aria and LSR II). 

Clinical:

Not applicable.

Animal:

Not applicable.

Computer:

PC’s, laptops, and printers are connected to a Dell PowerEdge 2500 Dual Processor 1GHz 

Pentium III Server with antivirus, firewall, and user authentication on a Dell PowerEdge 1800 

Quad 3 GHz Pentium 4 domain controller. Full nightly backups are performed. All users have 

workstations, laptops, or access to shared workstations, T-1 access to the internet, and secure 

remote access. Specialized and equipment-specific software programs available include 

Endnote (bibliography), Oracle 11i (financial), SAS 8.2 (statistical), ArcGIS (mapping and spatial 

analysis), Cardiff’s Teleform 8.1 (image interpretation) and Freezerworks (repository 

management) software.

Office:

Facilities Page 14

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
FACILITIES AND RESOURCES

Other:

Onan 350KW generator with a 900 gallon diesel tank available to provide emergency power to 

all temperature-critical equipment, computer server and other key equipment. Substantial plant 

operations support available, including carpentry and machine shop for minor repair/fabrication. 

Building security card key access. Secondary temperature monitoring system (Plexxium) for all 

temperature-critical equipment.

Facilities Page 15

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Province:

PROFILE - Project Director/Principal Investigator

Prefix: * First Name: Middle Name:

* Last Name: Suffix:

Organization Name: Division:

Position/Title: Department:

* Street1:

Street2:

* Phone Number: Fax Number:

* E-Mail:

Credential, e.g., agency login:

* Project Role: Other Project Role Category:

* Country: * Zip / Postal Code:

* State:

* City: County/ Parish:

Attach Current & Pending Support

RESEARCH & RELATED Senior/Key Person Profile (Expanded)

*Attach Biographical Sketch

Dr. Patricia

Garrett

Principle Scientist

Immunetics, Inc.

PD/PI

Ph.D.

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OMB Number: 4040-0001 

Expiration Date: 06/30/2011

Degree Type:

Degree Year:

Province:

PROFILE - Senior/Key Person

Prefix: * First Name: Middle Name:

* Last Name: Suffix:

Organization Name: Division:

Position/Title: Department:

* Street1:

Street2:

* Phone Number: Fax Number:

* E-Mail:

Credential, e.g., agency login:

* Country: * Zip / Postal Code:

* State:

* City: County/ Parish:

Dr. E

Scientific Director and President

Immunetics, Inc.

Andrew

Levin

* Project Role: Other (Specify) Other Project Role Category: Scientific Director

1

Degree Type: Ph.D.

Degree Year:

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Key Personnel Page 17

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED Senior/Key Person Profile (Expanded)

Province:

PROFILE - Senior/Key Person

Prefix: * First Name: Middle Name:

* Last Name: Suffix:

Organization Name: Division:

Position/Title: Department:

* Street1:

Street2:

* Phone Number: Fax Number:

* E-Mail:

Credential, e.g., agency login:

* Country: * Zip / Postal Code:

* State:

* City: County/ Parish:

Dr.

Principal Scientist

Immeuntics, Inc

Victor

Kovalenko

* Project Role: Other (Specify) Other Project Role Category: Principal Scientist

2

Degree Type: Ph.D.

Degree Year:

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Attach Current & Pending Support Add Attachment Delete Attachment View Attachment

Province:

PROFILE - Senior/Key Person

Prefix: * First Name: Middle Name:

* Last Name: Suffix:

Organization Name: Division:

Position/Title: Department:

* Street1:

Street2:

* Phone Number: Fax Number:

* E-Mail:

Credential, e.g., agency login:

* Country: * Zip / Postal Code:

* State:

* City: County/ Parish:

* Project Role: Consultant Other Project Role Category:

3

Degree Type:

Degree Year:

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Key Personnel Page 18

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
BIOGRAPHICAL SKETCH

Provide the following information for the Senior/key personnel and other significant contributors. 

Follow this format for each person. DO NOT EXCEED FOUR PAGES.

NAME 

Garrett, Patricia E. 

eRA COMMONS USER NAME (credential, e.g., agency login) 

POSITION TITLE 

Principal, Pat Garrett Consulting 

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and 

residency training if applicable.)

INSTITUTION AND LOCATION DEGREE

(if applicable) MM/YY FIELD OF STUDY

St. Francis College, Loretto, PA 

Georgetown University, Washington, D.C. 

University of Colorado, Boulder, CO

B.S. 

M.S. 

Ph. D.

06/65 

01/68 

08/70

Chemistry 

Chemistry 

Chemistry

A. Personal Statement

When I joined Boston Biomedica, Inc. in June, 1988, as the eighth employee and first Ph.D. scientist, BBI’s 

first HIV seroconversion panels had been in the marketplace for a year and were already gaining the tiny 

company visibility and influence far beyond its size. The utility of these panels in research and in 

diagnostics development and evaluation, and their commercial success, led us to assemble and 

manufacture other panels of samples carefully characterized for the marker(s) of interest, particularly in the 

fast-moving fields of blood- screening assays and HIV research. For this purpose, and for the line of 

quality control materials that we developed for HIV marker test methods, we collected HIV positive 

plasma units from plasma companies. That collection led to my first collaboration on incidence tests with Mike 

Busch, then of Blood Centers of the Pacific, and resulted in a poster presented at the Clinical Virology 

Symposium (CVS) in 1999. I have been working with leaders in the field on aspects of incidence testing 

ever since. Partially through my work, SeraCare has become a leader in the field of well-characterized HIV 

serum panels, including for assessment of test accuracy in detecting early infections. 

In 2003, I organized an unfunded study with Tom Folks at CDC of randomly collected HIV positive units, 

each tested with 12 candidate incidence test methods performed in nine laboratories, to determine 

consensus or lack thereof for recent or long-standing infection. That study resulted in a poster presentation 

at CVS in 2004, and a commercially available panel of 15 plasma samples with unknown dates of infection 

that were consensus incident or consensus prevalent by at least 11 tests. Much of my work in HIV 

incidence since then has been the collection of those ‘gold standard’ samples: whole blood or plasma 

from individuals with very closely estimated HIV infection dates (using the Fiebig algorithm, of which I 

played a part in the development). This work involved the same organizational and management skills that 

I have used for managing the design, development and evaluation of numerous other products. 

I originated the idea of combining the sample collection with development of an innovative new HIV 

incidence assay, the concept underlying the present application. While at SeraCare I entered into a 

collaboration with Immunetics and Diagnostic Innovations which had developed a novel rapid test 

technology, that led to the Phase I SBIR grant 1R43 AI098567 supporting our joint efforts to develop both 

plasma panels and the rapid incidence test. I served as the Principal Investigator under the Phase I grant. 

During this time, I have expanded the project by engaging CDC, WRAIR and BSRI as collaborators, which 

will provide unparalleled access to expertise, field trial capabilities and well-characterized sample panels for 

test evaluation. 

At the end of 2012, I retired from SeraCare and began a consulting practice, in which I continued to manage 

and represent SeraCare’s scientific interests with respect to the Phase I grant. Upon award of the Phase II 

grant, I will join Immunetics as an employee at ≥51% time, and will serve as the Principal Investigator for the 

grant. I believe that my extensive experience in the field of HIV testing and incidence measurement, literally 

from its beginnings through the present, is appropriate qualification supporting my role as Principal 

Investigator on the grant. 

Biosketches Page 22

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
B. Positions and Honors

Positions and Employment

1981 – 1988 Technical Director, Automated Chemistry, Immunoassay and STAT 

Laboratories, Lahey Clinic Medical Center, Burlington, MA 

1988 – 2004 Positions of increasing responsibility, culminating in Senior Vice President for 

Science and Technology, Boston Biomedica, Inc., West Bridgewater, 

MA 

2004 – 2012 BBI was purchased by SeraCare and I transitioned to Senior Director for 

Science and Technology, SeraCare Life Sciences, Inc., Milford, MA 

2013 – present Principal, Pat Garrett Consulting

Other Experience and Professional Memberships 

Diplomate, American Board of Clinical Chemistry 

Diplomate, National Registry of Clinical Chemists Member, 

Association for Molecular Pathology 

Former Member (6 year term), Board of Directors, American Board of Clinical Chemistry 

Fellow, National Academy of Clinical Biochemistry 

Volunteer writer and reviewer, Clinical Laboratory Standards Institute 

Member, American Association for the Advancement of Science 

Member, American Association for Clinical Chemistry 

Member, Clinical Ligand Assay Society 

C. Publications

1. Garrett, P.E. et al. “Serial Plasma/PBMC Collections from Recently HIV-infected 

Individuals” 2012 HIV Diagnostics Conference, December 12-13, 2012, Atlanta, GA 

2. Hallett, T. and the Incidence Assay Critical Path Working Group (2011). "More and 

Better Information to Tackle Epidemics: Towards Improved HIV Incidence Assays." PLoS 

Med. 8(6) e1001045. doi:10.1371/journal.pmed.1001045. 

3. Hess, R. D., B. C. Gartner, et al. (2005). "Meeting report: Part I. Notes from the 

Molecular Virology Workshop, 23-24 April 2004, Clearwater Beach, Florida, USA." J Clin Virol 

32(3): 259-262, PMID 16180266. 

4. Hess, R. D., B. C. Gartner, et al. (2005). "Meeting report: Part II. Notes from the 

Twentieth Annual Clinical Virology Symposium." J Clin Virol 32(4): 342-346, PMID 

15849874. 

5. Hess, R. D., Gartner, BC, Garrett, PE. (2005). "Meeting Report Part III. Notes from the 20th 

Annual Clinical Virology Symposium, April 25-28, 2004 Clearwater Beach, FL, USA." J Clin 

Virol 33(1): 83-87, PMID. 

6. Garrett, P. E., S. Crush-Stanton, et al. (2004). “Method comparison of HIV tests for recent 

infection.” 20th Annual Clinical Virology Symposium. Clearwater Beach, 

Florida. (Not peer-reviewed, but relevant to this project.) 

7. Fiebig, E. W., PE Garrett, et al. (2003). "Dynamics of HIV viremia and antibody 

seroconversion in plasma donors: implications for diagnosis and staging of primary HIV 

infection." AIDS 17(13): 1871-1879, PMID 12960819. 

8. Garrett, P. E. (2001). "Quality control for nucleic acid tests: common ground and special 

issues." J Clin Virol 20(1-2): 15-21, PMID 11163578. 

9. Bondarenko, I. G., P. E. Garrett, et al. (1999). "Lack of correlation between sensitivity 

characteristics of the tests for hepatitis C virus antibodies estimated with serially diluted and 

natural low-reactive control specimens." Scand J Clin Lab Invest 59(2): 

153-158, PMID 10353330. 

10. Garrett, P. E., V. L. MacKeen, et al. (1999). “Seroconversion Profiles and Detuned Testing in 

the Determination of HIV Incidence.” Clinical Virology Symposium. (Not peer-reviewed, but 

relevant to this project.) 

Biosketches Page 23

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
D. Research Support

CDC Contract Garrett (PI) 09/10/10-09/09/11 

Acquisition of Longitudinal Samples from HIV Infected Individuals

The goal of this project is to collect additional bleeds from 19 individuals with closely estimated 

infection dates who were recruited and previously bled under CDC Contract #200- 

2004-10206. As PI, my responsibility is to continue the relationships with the collection centers 

(San Francisco City Clinic and SeraCare’s Donor Recruitment Group), work with the 

group to amend the protocol (completed) and to transition the shipment and processing of samples 

to CDC (also completed). This small contract is on track to be completed on time 

and within budget in September 2011. 

CDC Contract Garrett (PI) 09/01/04-08/31/10 

Seroconverter Specimen Panels

The goal of this project was to collect serial bleeds over 15 months from documented dates of HIV 

infection from 70 individuals. As PI, I coordinated all aspects of the project, from protocol 

development through subcontractor agreements, protocol familiarization, process development, 

donor recruitment, scheduling and collection, sample shipment, processing, storage, and data 

collection, transfer, and organization for the prospective collections, and identification, negotiation, 

material transfer agreements, IRB approvals, and shipments to CDC for the retrospective 

collections. In six years, I worked with and/or managed a group that included three successive 

CDC Project Officers, four potential clinical sites, one actual clinical site, three retrospective 

collection sites outside of SeraCare, and two groups within SeraCare that recruited additional 

donors and processed, stored, and shipped all the samples and data. None of the people involved 

reported to me, yet cooperation was good and we brought the project to a successful conclusion. 

CRS-2007-T 620 Manak (PI), Garrett (PI) 12/15/07-7/30/10 

Subcontract to PPD NIH HHSN26620050022C 

"Characterization of HIV Subtypes in a GLP Environment" Logistics and laboratory 

support for collection of HIV isolates from around the world, virus isolation, characterization, panel 

manufacture, and distribution. As Co-PI, I was responsible for all documentation and data 

handling, and was the contact person for donor organizations that were providing plasma or viral 

isolates for analysis and consideration for panel members. 

Biosketches Page 24

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
BIOGRAPHICAL SKETCH

NAME

Andrew E. Levin

POSITION TITLE

Scientific Director and President

eRA COMMONS USER NAME: 

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.)

INSTITUTION AND LOCATION DEGREE

(if applicable) YEAR(s) FIELD OF STUDY

Princeton University, Princeton, NJ A.B. 1972-1976 Biochemistry

University of Wisconsin, Madison, WI Ph.D. 1977-1984 Molecular Biology

Harvard University, Cambridge, MA Post-doc 1984-1987 Cell & Dev. Biology

A. Personal Statement.

As President and Scientific Director of Immunetics which I founded in 1987, I have spent over 20 years on 

the development and commercialization of in vitro diagnostic test products, mostly for esoteric infectious 

diseases. During this time, I have developed and/or launched new assay kits based on ELISA and 

Western Blot technologies, some of my own invention, for a wide range of diseases including HIV, HTLV, 

Lyme disease, Cysticercosis, Hydatid Disease, Babesiosis, Ehrlichiosis, SARS, Anthrax and others. In 

recent years I have led the development of a molecular diagnostics technology with broad application to 

clinical and public health needs for pathogen detection, and I have brought from concept to 

commercialization the novel BacTx® test for bacterial contamination in platelets. I have gained experience 

in clinical trial and regulatory pathways to FDA approvals for a range of in vitro diagnostic products. As 

President and Scientific Director of a profitable and growing in vitro diagnostic business, I have been 

successful in identifying opportunities where medical needs, scientific technology and business potential 

intersect. I believe that these attributes make me well-suited for the role of Principal Investigator on the 

proposed project.

B. Positions and Honors.

1976–1977 Massachusetts General Hospital, Boston, MA

Research Technician, Genetics Unit

1977–1984 University of Wisconsin, Dept. of Biochemistry, Madison, WI

 Graduate Student, Recipient of NIH Predoctoral Fellowship Award

1981 Centre de Génétique Moléculaire, CNRS, Gif-sur-Yvette, France

 NATO Exchange Researcher

1984–1987 Harvard University, Cambridge, MA, Dept. of Cellular and Developmental Biology

 NIH Postdoctoral Fellow

1987-Present Immunetics, Inc., Boston, MA

Scientific Director, Founder and President

Professional Associations

American Association of Blood Banks American Society for Microbiology

American Association of Clinical Chemistry American Society for Tropical Medicine and Hygiene

C. Selected peer-reviewed publications (in chronological order):

1. “Single-tier testing with the C6 peptide ELISA kit compared with two-tier testing for Lyme disease”, Wormser 

GP, Schriefer, Aguero-Rosenfeld ME, Levin A, Steere AC, Nadelman RB, Nowakowski J, Marques A, Johnson 

BJ, Dumler JS, Diagn Microbiol Infect Dis 2012 Oct 10 Epub (10.1016/j.diagmicrobio.2012.09.003)

2. “Identification of bacteria in scuba divers’ rinse tanks”, Washburn BK, Levin AE, Hennessy K and Miller, 

MR, Undersea Hyperb Med 37(4):233-40, 2010. PMID: 20737930. 

3. “Serological diagnosis of Taenia solium cysticercosis using recombinant and synthetic antigens in 

QuickELISATM”, Lee Y-M, Handali S, Hancock K, Pattabhi S, Kovalenko V, Levin AE, Rodriguez S, Castillo 

Berrios Y, Noh J, Silva-Ibanez M, Lin S, Scheel CM, Gonzalez AE, Gilman RH, Garcia HH, and Tsang VCW, 

Am. J. Trop. Med. Hyg. 84(4), 2010. PMID: 21460015. 

Biographical Sketches for each listed Senior/Key Person 2 Page 25

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Andrew E. Levin, Ph.D.

PHS 398/2590 (Rev. 05/01) Biographical Sketch Format Page 

4. “Impact of clinical variables on Borrelia burgdorferi-specific antibody seropositivity in acute-phase sera from 

patients in North America with culture-confirmed early Lyme disease”, Wormser GP, Nowakowski J, 

Nadelman RB, Visintainer P, Levin A, and Aguero-Rosenfeld ME.Clin. Vacc. Immunol. (2008) 15:1519-22. 

PMID: 18716009. 

5. “Effect of Borrelia burgdorferi genotype on the sensitivity of C6 and two-tier testing in North American 

patients with culture-confirmed Lyme disease”, Wormser GP, Liveris D, Hanincova K, Brisson D, Ludin S, 

Stracuzzi VJ, Embers ME, Philipp MT, Levin A, Aguero-Rosenfeld M and Schwartz I, Clin. Infect. Dis. (2008) 

47:910-914. PMID: 18724824

6. ”Detection of anti-Borrelia antibodies by immunoblotting in Lyme Borreliosis”, Anan'eva LP, Studentsov EE, 

Levin A., Klin Lab Diagn (2002) Jun;(6):45-7.

7. “Diagnosis of babesiosis using an immunoblot serologic test”, Ryan R, Krause PJ, Radolf J, Freeman K, 

Spielman A, Lenz R, Levin A., Clin Diagn Lab Immunol (2001) 8(6):1177-80.

8. ”Human granulocytic ehrlichiosis (HGE) and babesiosis: tick-borne diseases” in Für die Praxis: LymeBorreliose, ed. T. Talaska, Frankfurt (Oder), 1998.

9. ”Monoclonal anti-dipeptide antibodies cross-react with detyrosinated and glutamylated forms of tubulins”, 

Kuriyama R, Levin A, Nelson D, Madl J, Frankfurter A, Kimble M., Cell Motil Cytoskeleton (1995) 30(3):171-82

10. “Checkerboard DNA-DNA Hybridization”, Socransky, S.S., Smith, C., Martin, L., Paster, B.J., Dewhirst, 

F.E. and Levin, A.E., Biotechniques (1994);17:788-792.

11. “Purification and characterization of a calcium-dependent ATPase from Paramecium tetraurelia”, A.E. 

Levin, S. Travis, L.D. DeVito, K.A. Park and D.L. Nelson, J Biological Chemistry (1989) 264: 4544-4551.

12. “Abolition of actin-bundling by phosphorylation of human erythrocyte protein 4.9”, A. Husain-Chishti, A. 

Levin and D. Branton, Nature (1988) 334: 718-721. 

13. “Assembled clathrin in erythrocytes”, D. Bar-Zvi, A. Levin and D. Branton, Journal of Biological Chemistry

(1987) 262: 17719-17723.

14. “Copper staining: A five-minute protein stain for sodium dodecyl sulfate-polyacrylamide gels”, C. Lee, A. 

Levin and D. Branton, Analytical Biochemistry (1987) 166: 308-312.

Selected Abstracts

1. Erwin J.L., Ni X., Wang H., Krueger N.X., Telford S.R., Krause P.J., Busch M.P. and A.E. Levin (2012) 

“Sensitive and Specific Peptide-Based ELISA for Detection of Antibodies to Babesia microti”, Poster SP412, 

American Association of Blood Banks Annual Meeting, Oct. 2012.

1. Furniss, C.S., Shekar, S., Hennessy, K., Perry, L., Doron, S., Snydman, D., Krueger, N.X. and A.E. Levin 

(2010) “Rapid Detection of Antibiotic Resistance Genes in Bacterial Pathogens Associated with HospitalAcquired Pneumonia by Reverse Line Blot Assay”, American Soc. of Microbiology Annual Meeting, May 2010.

2. Washburn, B.K., Hennessy, K.T., Levin, A.E., Libby, B.J., Castelblanco, A.S., Cubilos, G.F., Kett, D.H. and 

Snydman, D.R. 2008. Semi-automated reverse line blot assay for detection and identification of bacteria and 

fungi in clinical samples. American Society of Microbiology Annual Meeting, June 2008, Abstract #C-054.

3. Kirby, C., L. Beausang, V. Kovalenko and A. Levin (2005) „BacTx – A Rapid Assay for the Detection of 

Bacteria in Platelet Units“, American Association of Blood Banks, Nov. 2005.

3. Levin, A., Beausang, L., Kirby, C., Syrkina, M. and V. Kovalenko (2005) “C6 ELISA Specificity vs. Two-Tier 

Testing Protocol”, X International Conference on Lyme Borreliosis, Vienna, Sept. 2005.

4. Septak, M., P. Wilkins, L. Chalcraft, K. Stamey, M. Syrkina, V. Kovalenko, C. Quinn and A. Levin (2004) 

“Clinical Validation of a Novel Anthrax ELISA for the Detection of Antibodies to Protective Antigen”, American 

Society of Microbiology, May 2004.

5. Andrew E. Levin, Peter Condon and Victor Kovalenko, (2002) “Lyme Borreliosis Serodiagnosis by ELISA 

Based on the C6 Peptide of VlsE”, International Conference on Lyme Borreliosis, Belgium, 2001. 

6. Levin, A., Condon, P. and Kovalenko, V. (2002) “C6 peptide ELISA for Lyme serodiagnosis: Equivalent to 

two-tier testing ?”, IX International Conference on Lyme Borreliosis, New York, 2002. Oral presentation O-172.

7. Andrew Levin, Thomas Talaska and Victor Kovalenko (2002) “C6 Peptide ELISA: Universal assay for 

detection of European Lyme borreliosis ?”, IX Int’l Conf. on Lyme Borreliosis, New York, 2002. Abstract P-149.

8. Levin, A.E. , Condon, P.C., Syrkina, M., Shmuter, G. and Oddo, S. (1999) “Fifteen-minute Lyme Western 

Blot with automated neural network interpretation”,

VIII International Congress on Lyme Borreliosis and Related Tick-Borne Diseases, Munich.

9. Levin, A.E. and Talaska, T. (1998) “Serologic Evidence of Coinfection with HGE and Borrelia burgdorferi in 

Germany”, First Congress of European Society for Emerging Infections, Budapest.

Biographical Sketches for each listed Senior/Key Person 2 Page 26

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Andrew E. Levin, Ph.D.

PHS 398/2590 (Rev. 05/01) Biographical Sketch Format Page 

10. Levin, A.E., Shmuter, G.M. and MacDonnell, P. (1998) “An accelerated membrane immunoassay for 

Bartonella henselae antibodies”, American Soc. for Trop. Medicine and Hygiene Annual Meeting, Abstract 174.

11. Levin, A.E., Shmuter, G.M. and Studentsov, Y. (1997) “Membrane-based assay distinguishes Chagas’ and 

Leishmania antibodies”, American Soc. of Trop. Med. and Hygiene Annual Meeting, 1997. Abstract 222.

12. Levin, A., Nicoll, C., Rowell, S. and Studentsov, Zh. (1997) “Canine Lyme disease kit distinguishes 

vaccinated from infected dogs”, American Veterinary Medical Association Annual Meeting, Abstract.

13. Levin, A. and Shmuter, G. (1996) “Evaluation of Western Blot assays for detection of human antibodies to 

Taenia solium and Echinococcus granulosus”, American Soc. for Microbiology Annual Meeting, Abstract V-51.

Patents:

Application #13/657,394 Sensitive and Specific Assay for Babesia spp. (pending), filed 10/22/2012.

“Rapid peptidoglycan-based assay for detection of bacterial contamination of platelets”, U.S. Pat. No. 

7,598,054, issued 10/06/09

"Rapid Flow-Through Binding Assay Apparatus and Method", U.S. Pat. No. 6,303,389, issued 10/16/01

"Systems and Methods for Rapid Blot Screening", U.S. Pat. No. 6,194,160 issued 2/27/01

"Modified Western Blot Membrane and Method for Detecting Lyme Disease and Other Tick-Borne Diseases", 

U.S. Pat. No. 6,013,460, issued 1/11/00

"Binding Assay Device with Removable Cassette and Manifold", U.S. Patent No. 5,100,626 issued 3/31/92

"Apparatus for Blot Screening Numerous, Small Volume, Antibody Solutions", U.S. Patent No. 4,834,946 

issued 5/30/89

"Fluid Flow Manifold for Blot Type Screening Apparatus", U.S. Patent No. 4,978,507 issued 12/18/90

"Templet for Simultaneous Screening of Several Antibodies and Method of Using the Same", U.S. Patent No. 

4,713,349 issued 12/15/87

"Protein Detection by Negative Staining", U.S. Patent No. 4,782,027 issued 11/1/88

D. Research Support:

Current (selected):

SBIR Phase II Contract No. HHSN268201200067C “Screening and Confirmatory Tests for Human 

Babesia” 

Agency: National Heart, Lung and Blood Institute/NIH

Performance Period: 08/31/2012 – 08/30/2014 Role: PI

Summary: Clinical evaluation under IND of an immunoassay for detection of antibodies to Babesia microti for 

use in blood screening. Based on an ELISA developed with specific B. microti synthetic peptide antigens. 

SBIR Phase I Grant No. 1R43AI100471 “Immunoassay for Diagnosis of Babesia Infection” 

Agency: National Institute of Allergy and Infectious Diseases/NIH

Performance Period: 12/15/2012 – 11/30/2014 Role: PI

Summary: Identification of peptide antigens for development of an immunoassay for detection of antibodies to 

Babesia microti and other human pathogenic Babesia species for in vitro diagnostic use. 

Completed (selected): 

Grant No. AI078567 “Detection of Antibiotic Resistance Genes in Bacterial Agents of Hospital-Acquired 

Pneumonia and Sepsis”

Agency: National Institute of Allergy and Infectious Diseases/NIH

Performance Period: 05/15/2008 – 04/30/2010

Summary: Further development and application of the reverse line blot assay developed under AI66564 to 

detect antibiotic resistance genes in bacteria derived from whole blood or respiratory samples, from patients 

with sepsis or hospital-acquired pneumonia.

Grant No. U01 AI66564 “Reverse Line Blot Diagnostic Test for Agents of Sepsis”

Agency: National Institute of Allergy and Infectious Diseases/ National Institutes of Health

Performance Period: 07/01/05 – 06/30/08 Role: PI

Summary: Development of a Reverse Line Blot assay to detect and identify bacterial agents of sepsis directly 

from whole blood samples, based on amplification with universal primers and hybridization with speciesspecific probes.

Grant No. 1 R43 AI064988-01 (PI: Kovalenko) “Peptide-Based Serodiagnostic Test for Cysticercosis” 

Agency: National Institute of Allergy and Infectious Diseases/ National Institutes of Health

Biographical Sketches for each listed Senior/Key Person 2 Page 27

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Andrew E. Levin, Ph.D.

PHS 398/2590 (Rev. 05/01) Biographical Sketch Format Page 

Performance Period: 4/01/05 – 7/31/08 Role: Coinvestigator

Summary: Development of a serologic test for cysticercosis based on new peptide antigens in an antibody 

capture ELISA format.

Grant No. AI59329-01 “Identification of SARS Antigens for Serodiagnosis”

Agency: National Institute of Allergy and Infectious Diseases/ National Institutes of Health

Performance Period: 4/01/04-3/31/07 Role: PI

Summary: Identification of peptide epitopes suitable for use in immunodiagnostic assays for SARS infection. 

Synthetic and recombinant sequences of viral proteins will be produced to define antigenic epitopes.

Grant No. HL65877 (Phase II) “Rapid Assay for Bacterial Contamination of Platelets”

Agency: National Heart, Lung and Blood Institute/National Institutes of Health

Performance Period: 10/01/02 – 8/31/10 Role: PI

Summary: Continuation of the Phase I project. Development of an assay based on peptidoglycan-binding 

proteins of invertebrate hemolymph for the detection of bacteria in platelet units. The peptidoglycan-binding 

assay offers high sensitivity and specificity in a simple, inexpensive format for blood bank or point-of-care use.

Contract No. 00713 “Anthrax Serology Test”

Agency: Centers for Disease Control, National Center for Infectious Diseases

Performance Period: 9/26/02 – 9/26/07 Role: PI

Summary: This contract covered the development and production of an ELISA assay for antibodies to anthrax 

Protective Antigen (PA). The ELISA assay was based on Immunetics’ QuickELISATM format. It was

developed in kit form, validated, and received FDA 510(k) approval. The assay kits will be provided to U.S. 

government public health laboratories for use in the event of an anthrax attack.

Grant No. AI51926 (Phase I) “Single Step Peptide ELISA for Lyme Serodiagnosis”

Agency: National Institute of Allergy and Infectious Diseases/ National Institutes of Health

Performance Period: 3/15/02 – 3/14/04 Role: PI

Summary: This project was aimed at a clinical trial comparison of Immunetics’ C6 peptide Lyme ELISA with the 

current CDC two-tier protocol for Lyme serodiagnosis. The peptide ELISA would replace the two-tier protocol 

with a simpler, more accurate and more cost-efficient alternative for Lyme disease testing.

Grant No. AI44541 (Phase I) “Neural Network for Lyme Western Blot Interpretation”

Agency: National Institute of Allergy and Infectious Diseases/ National Institutes of Health

Performance Period: 3/1/99-8/31/99 Role: PI

Summary: Immunetics developed the first neural network software program for automated interpretation of 

Lyme Western Blot band patterns. The neural network yielded results equal to or exceeding those of human 

interpreters in sensitivity and specificity. With this software program, Western Blots could be scanned and 

interpreted instantly by computer with objectivity, reproducibility and high accuracy.

Grant No. AI43123-03 (Phase I and Phase II) “Tick-Borne Disease Panel Test”

Agency: National Institute of Allergy and Infectious Diseases/ National Institutes of Health

Performance Period: 3/1/98 – 2/28/02 Role: PI

Summary: Development of a panel of tests for tick-borne pathogens including Lyme, Human Granulocytic 

Ehrlichiosis, and Human Babesiosis. Lyme, HGE and Babesia native and recombinant antigens were tested in 

ELISA, dot blot and Western Blot formats. Development resulted in the first ELISA assays for HGE and 

Babesia based on semi-purified native antigen lysates. The Babesia Western Blot was validated in a study 

published in Clinical and Diagnostic Laboratory Immunology (2001) 8(6):1177-1180.

Grant No. AI40849 (Phase II) “Rapid Confirmatory Lyme Disease Test”

Agency: National Institute of Allergy and Infectious Diseases/ National Institutes of Health

Performance Period: 9/15/97 – 2/29/00 Role: PI

Summary: Continuation of CDC contract 200-93-0666, development of a rapid immunoassay for Lyme 

serodiagnosis. A wide range of recombinant Lyme antigens were evaluated for sensitivity and specificity. The 

C6 peptide sequence within VlsE was chosen for the final version. The C6 peptide Lyme ELISA was patented, 

validated, received FDA 510(k) approval, and has been launched commercially by Immunetics.

Biographical Sketches for each listed Senior/Key Person 2 Page 28

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Program Director/Principal Investigator (Last, First, Middle): Kovalenko, Victor A.

PHS 398/2590 (Rev. 11/07) Page Biographical Sketch Format Page

BIOGRAPHICAL SKETCH

NAME 

 Kovalenko, Victor A.

POSITION TITLE

Principal Scientist, Immunetics, Inc.

President, Diagnostic Innovations, 

eRA COMMONS USER NAME (credential, e.g., agency login) LLC

INSTITUTION AND LOCATION DEGREE

(if applicable) YEAR(s) FIELD OF STUDY

Moscow State University M.S. 1970 Biochemistry

Institute of Bioorganic Chemistry, Russian Academy of 

Sciences 

Ph.D. 1983 Bioorganic Chemistry

A. Personal Statement 

I have spent all my scientific career developing sensitive bioanalytical and diagnostic detection methods utilizing 

a broad spectrum of detection labels – radioactive, enzymes, colloidal gold and carbon, pigment colloids, latex 

particles, and fluorescent labels. As a group leader at the Laboratory of Biotechnology, Institute of Bioorganic 

Chemistry, Moscow, I have supervised development of analytical methods and diagnostic test systems in 

various formats: ELISA, dot-blot, dipstick, passive diffusion, latex agglutination, and immunochromatography. 

These methods were applied to the development of various research diagnostic tests - human immunodeficiency 

virus, leptospirosis, tick-borne encephalitis, Streptococcus group A rapid antigen and antibody tests, detection of 

various recombinant proteins, neuropeptides, free and bound biotin, detection of E.coli contamination in 

recombinant proteins. As a Principal Investigator of the grant from the Russian Medical Academy I have 

develop HIV diagnostic test utilizing peptide antigens 

In 1986 I have founded the Department of Bioanalytical Reagents and Diagnostic Methods, at the Peptide 

Engineering Center for Innovative Research "PEPTOS" (Shemyakin Institute of Bioorganic Chemistry, Russian 

Academy of Sciences, Moscow). The department conducted research and development in the area of 

bioanalytical methods, focusing on application of the biotin-streptavidin system for development of amplified 

detection systems, diagnostic test systems and broad spectrum of reagents such as streptavidin, biotin 

derivatives, detector enzymes, enzyme conjugates, including polymerized HRP, colloidal carbon and pigment

conjugates, affinity sorbents, blocking reagents and enzyme substrates. Several innovative approaches were 

related to application of polymerized forms of enzymes for signal amplification and using carbon and pigment 

colloidal particles for development of sensitive and simple rapid tests. 

In 1994 I was invited to work in the USA as a Senior Scientist at BINAX, Inc. (Portland, ME), the developer and 

manufacturer of the ELISA and rapid lateral flow tests. There I was responsible for development of diagnostic 

reagents and amplified assays. I have developed new amplified tests in several ELISA formats for detection of 

bacterial antigens, chlamydial lipopolyssaccharide, gonorrhea, Legionella, Streptococcus group A, Streptococcus 

group B, Salmonella, and E.coli. I have developed lateral flow tests for detection of Chlamydia trachomatis and 

whole blood lateral-flow tests for detection of panel of human cardiac markers. My work also was directed on 

development of a new approaches for reduction of non-specific reactions in immunological tests using chemical 

modification of antibodies and developed methods for stable adsorption of analytes on colloidal gold based on 

analysis of affinity of various chemical groups to colloidal particles.

In 1999 I have moved to work at Immunetics, Inc (Boston, MA), where I became Principal Scientist in Diagnostic 

Methods and Reagent Development, and later in Rapid Tests Development. Here I made critical contributions to 

creation of several new products and intellectual property. Three tests, either developed by me or utilizing my 

inventions, were commercialized and received FDA approval, including the first C6 peptide test for Lyme disease 

(2002), the serological Anthrax PA test (2004), and a test for bacterial contamination in platelet units utilizing 

colorimetric method for detection of bacterial peptidoglycans (2012). New assay format utilizing peptide 

Biographical Sketches for each listed Senior/Key Person 3 Page 29

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Program Director/Principal Investigator (Last, First, Middle): Kovalenko, Victor A.

PHS 398/2590 (Rev. 11/07) Page Continuation Format Page

conjugates (QuickELISA) was used successfully in numerous grants and contracts for development of sensitive 

and specific ELISA tests, including antibodies against C6 and C10 Lyme diagnostic peptides, antibodies against 

SARS virus nucleocapside and spike proteins, H5 avian influenza, serological test for Taenia solium tapeworm 

cysticercosis and taeniasis antigens, as well as for application in rapid test formats for antibody detection (Lyme, 

Cysticercosis, Influenza, and Chagas disease, Human Immunodeficiency Virus). 

In 2007 I have founded Diagnostic Innovations, LLC (Scarborough, ME), as President and Research Director. 

This company is focused on invention-based development of the sensitive colorimetric detection system for rapid 

diagnostic tests and bioanalytical applications which use peroxidative enzymes as a label. In the five years since 

its inception, the company has developed many unique reagents of the substrate system for application in a 

various membrane-based rapid tests. The company performed several feasibility studies for application of the 

new technology for detection of antigens, disease markers, antibodies, and bacterial cells, which demonstrated 

the big potential of the new technology for development of highly sensitive rapid tests in various formats

In summary, I have demonstrated a combination of experience covering all major aspect of assay development 

and of productive research and development work leading to commercial products and new technologies. 

B. Positions and Employment

1970-1973 Research Scientist, Institute of Biological Physics, Biological Center of the Russian Academy of 

Sciences, Pushchino, Russia

1973-1976 Research Scientist, Joint Laboratory of Protein Chemistry, Institute of Protein Research and 

Schemyakin Institute of Bioorganic Chemistry, Moscow, Russia

1976-1994. Senior Research Scientist, Shemyakin Institute of Bioorganic Chemistry, Moscow, Russia 

(Laboratory of Protein Chemisrty and Laboratory of Biotechnology) 

1986-1993 Founder and Director of the Department of Bioanalytical Reagents and Diagnostic Methods, 

Institute-based Peptide Engineering Center for Innovative Research "PEPTOS", Shemyakin Institute 

of Bioorganic Chemistry, Russian Academy of Sciences, Moscow, Russia

1993 Visiting Scientist, Weizmann Institute of Science, Laboratory of Prof. Meir Wilchek, Israel 

1994-1999 Senior Research Scientist and Project Manager, Binax, Inc., Portland, ME. 

1999-Present Principal Scientist, Diagnostic Methods and Reagent Development, Immunetics, Inc., 

 Boston, MA. 

2007-Present Scientific Director, Founder and President/Managing Partner, Diagnostic Innovations, LLC, 

 Scarborough, ME

Author of more than 35 publications and 5 patents

Patents :

Victor A. Kovalenko. U.S. Patent No. US7,125,517B2 “System and methods for detection of analytes in biological fluids” 

Issued 10/24/06

Victor Kovalenko. U.S. Patent No. 7,262,019 B2 “System and methods for detection of Bacillus anthracis related analytes in 

biological fluids”, Issued 9/28/07

Victor Kovalenko, Andrew E. Levin, Lee Anne Beusang. U.S. Patent 7,589,054 B2 “Rapid peptidoglycan-based assay for 

detection of bacterial contamination of platelets” Issued 10/6/2009

Victor Kovalenko. U.S. Application 61/494/232 Color-Producing Diagnostic Systems, Reagents and Methods. Filed June 7, 

2012

Selected peer-reviewed publications

Yeuk-Mui Lee, Sukwan Handali, Kathy Hancock, Sowmya Pattabhi, Victor A .Kovalenko, Andrew E. Levin, Silvia Rodriguez, 

Yesenia Castillo Berrios, John Noh, Maria Silva-Ibanez, Sehching Lin, Christina M.Scheel, Armando E. Gonzalez, Robert H. 

Gilman, Hector H. Garcia, and Victor C.W. Tsang. 

 Serological diagnosis of Taenia solium cysticercosis using recombinant 

and synthetic antigens in QuickELISATM. Am. J. Trop. Med. Hyg. 84(4), 587-593, 2011

Sukwan Handali, Sowmya Pattabi, Yeuk-Mui Lee, Maria Silva-Ibanez, Victor A. Kovalenko, Andrew E.Levin, Armando 

E.Gonzalez, Jacquelin M. Roberts, Hector H.Garcia, Robert H.Gilman,Kathy Hancock, and Victor C.W.Tsang.(2010) 

Development and evaluation of porcine cysticercosis QUICKELISATM in Triturus EIA analyzer. J Immunoassay Immunochem, 

31:60-70

Pavlova I.S., Lukin Yu.V., Kovalenko V.A., Avdeev D.N., Kulshin V.A., Zubov V.P. (1994) Non-instrumental immunoassay 

based on colored polyacrolein latex: application to group-specific polysaccharide of Steptococcrus pyogenes.. Bioorg Khim 

(Russ.), 20, 731-739.

Biographical Sketches for each listed Senior/Key Person 3 Page 30

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Program Director/Principal Investigator (Last, First, Middle): Kovalenko, Victor A.

PHS 398/2590 (Rev. 11/07) Page Continuation Format Page

Stratieva-Taneeva P.A., Khaidukov V.A., Kovalenko V.A., Nazimov I.V., Samokhvalova L.V., Nesmeyanov V.A. (1993) 

Bispecific monoclonal antibodies to human interleukin 2 and horseradish peroxidase. Hybridoma ,12, 271-284.

Kiseleva V.I., Kolesnik T.B., Turchinsky M.F., Wagner L.L., Kovalenko V.A., Plaksin D.Yu., Koukalova B., Kuhrova V., 

Brabec V., Poverenny A.M.(1993) Trans-Diaminedichlorplatinum(II)-modified probes for detection of picogram quantities 

of DNA. Anal. Biochem., 206, 43-49. 

Pomelova V.G., Zavodchicova E.N., Lavrova N.A., Kovalenko V.A., Gaidamovich S.Ia. (1992) The effectiveness of 

lanthanide immunofluorescence and immunoenzyme analyses in differentiating viruses of the tick-borne encephalitis 

complex. Vopr. Virusol.(Russ.), 37, 244-247.

Golovnina T.A.,Kasheverov I.E.,Plaksin D.Yu.,Yakunina N.B., Kovalenko V.A., Utkin Yu.N., Tsetlin V.I. (1992) New 

enzyme immunoassay for detection of Supstance P receptors based on biotin-streptavidin system. Bioorg Khim (Russ.), 18, 

932-941.

Zavodchikova E.N., Lavrova N.A., Kovalenko V.A. (1991) Using of biotin-streptavidin complex in immunoenzyme analysis of 

tick-borne encephalitis. Advances in Science and Technology. Suppl.Virology, Moscow, pp.89-99. 

Petrenko A.G., Kovalenko V.A., Shamotienko O.G., Surkova I.V., Tarasyuk T.A., Uskaryov Yu.A., Grishin E.V. (1990) 

Isolation and properties of the alpha-latrotoxin receptor. EMBO J, 9, 2023-2027. 

Petrenko A.G., Shamotienko O.G., Surkova I.N., Kovalenko V.A., Grishin E.V. S. (1990) Studies on the receptor for 

neurotoxin from black-widow spider venom. 1. Characterization of membrane-bound and solubilazed receptor from bovine 

brain. Bioorg Khim, 16, 149-157.

Petrenko A.G., Surkova I.V, Shamotienko O.G., Kovalenko V.A., Krasnoperov V.N., Tretiakov L.A., Ushkaryov Y.A., Grishin 

E.V. (1990). Studies on the receptor for neurotoxin from black-widow spider venom. 2. Isolation and properties of the receptor 

from bovine brain membrane., Bioorg Khim , 16, 158-165.Petrenko A.G., Kovalenko V.A.,Shamotienko O.G.,Surkova I.V, 

Tarasyuk T.A., Uskaryov Yu.A.,Ovchinnikov Yu.A. (1988).Studies on the receptor for neurotoxin from black-widow spider 

venom, Neurochemistry Int.,138, 159.Grishin. E.V., Kovalenko V.A., Pashkov V.N., Shamotiyenko O.G. (1984) Isolation 

and characteristics of sodium channel components. "Biologhicheskiye membrany" (Russ.), 1, 858-867.

Grishin E.V., Kovalenko V.A., Ovchinnikov Yu.A., Petrenko A.G., Prosolova T.K., Soldatov N.M. (1983) Identification of 

sodium channel components interacting with neurotoxins. In the book: "Toxins as tools in neurochemistry" 

Eds.F.Hucho,Yu.A.Ovchinnikov; Walter de Greyter and Co., Berlin - New York, pp.47-58.

Kovalenko V.A., Pashkov V.N., Grishin E.V., Ovchinnikov Yu.A., Shevchenko V.P., Myasoedov N.F. (1982) Synthesis of 

biologically active tritium labeled tetrodotoxin derivative. Bioorg Khym (Russ.),8, 710-712.

Kovalenko V.A., Vulphius E.A. (1978) Molecular organization, properties and isolation of acetylcholine receptor. Advances 

in Science and Biotechnology. Suppl. Biophysics, Moscow, pp.8-96

Selected Abstracts

Oksana Penezina, David Clapham, Jillian Collins, Victor Kovalenko, Neil Krueger, Sunitha Matthew, Isaac R.RodriguezChavez, Andrew Levin (2012). HIV Selectest: a new peptide-based enzyme immunoassay successfully distinguishes HIV 

vaccine-induced seropositivity from HIV infections in RV144, VAX003 and VAX004 vaccine trial participants. Poster, XIX 

International AIDS Conference, Washington, DC. 22-27-July 2012

Lee YM, Patthabhi S, Kovalenko VA, Handali S, Hancock K, Garcia HH, Gonzalez AE, Gilman RH, Tsang VCW. (2006) Use 

of rT24H QuickELISA assay in diagnosis of cysticercosis. (poster) ASTMH Atlanta, 

Levin A., Beausang L., Kirby C, M. Syrkina, V. Kovalenko (2005) C6 ELISA Specificity vs. Two-Tier Testing Protocol, X 

International Conference on Lyme Borreliosis , Sept. 2005

Kirby C., L. Beausang, V. Kovalenko and A. Levin (2005) “BacTx-A Rapid Assay for Detection of Bacteria in Platelet Units” , 

American Association of Blood Bank, Nov. 2005 

M. Septak, P. Wilkins, L. Chalcraft, K. Stamey, M. Syrkina, V. Kovalenko, C. Quinn and A. Levin, (2004). Clinical Validation of 

a Novel Anthrax ELISA for the Detection of Antibodies to Protective Antigen Abstract of American Society of Microbiology 

annual meeting, May 2004, Los Angeles

Levin, A., Condon, P. and Kovalenko, V.(2002) “C6 peptide ELISA for Lyme serodiagnosis: Equivalent to two-tier testing?”, IX 

International Conference on Lyme Borreliosis, New York, 2002. O-172.

Andrew Levin, Thomas Talaska and Victor Kovalenko (2002) “C6 Peptide ELISA: Universal assay for detection of European 

Lyme borreliosis ?”, IX International Conference on Lyme Borreliosis, New York, 2002. Abstract P-149.

Andrew E. Levin, Peter Condon and Victor Kovalenko, (2002) “Lyme Borreliosis Serodiagnosis by ELISA Based on the C6 

Peptide of VlsE”, International Conference on Lyme Borreliosis, Belgium, 2001.

Fedyuk N.V., Konovalov E.E., Pokrovsky A.G.,Loktev V.B., Kovalenko V.A.(1992) Detection of the core HIV-1 antigen p24 by 

enzyme immunoassay (EIA) and immunofluorescence assay. Abstracts VII International conference on AIDS/II STD 

World Congress, Amsterdam, The Netherlands, 19-24 July, p.20.

Fedyuk N.V., Konovalov E.E., Pokrovsky A.G.,Loktev V.B., Kovalenko V.A., Plaksin D.Yu. (1992) Detection and quantitation 

of p24 antigen of human immunodeficiency virus. Abstracts: Symposium "Structure and function of regulatory 

polypeptides", Moscow, p.18.

Biographical Sketches for each listed Senior/Key Person 3 Page 31

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Program Director/Principal Investigator (Last, First, Middle): Kovalenko, Victor A.

PHS 398/2590 (Rev. 11/07) Page Continuation Format Page

Kovalenko V.A. et al. (1988) Sensitive test-system for determination of free biotin, molecules modified by biotin and biotinbinding proteins. Abstract. All-Union Conference "Modern trends in creating of medical diagnosticum", 13-14 December, 

Moscow, p. 51

D. Research Support

Current: 

Grant No. 1R43AI091291-01. “Rapid point-of-care test for Lyme serodiagnosis based on novel highly-sensitive detection 

technology”. 

Agency: National Institute of Allergy and Infectious Diseases/NIH

Performance period: 07/01/2010 – 07/01/2013 (extended) 

Summary: Development of a rapid test for Lyme disease for point-of-care application utilizing peptide antigens and new 

highly sensitive detection technology with peroxidase label and multicolor colorimetric substrate system 

Grant Number: 1 R43 AI098567-01A1 

Project Title: Rapid Test for Recent HIV Infection and Incidence Panels for Assay Evaluation

Period 07/12/2012-07/12/2014 

Role: Co-investigator 

Institution: SERACARE LIFE SCIENCES, INC./Immunetics, Inc. Principal Investigator: Garrett, Patricia Ellen

Summary: Development of rapid lateral flow test based on new colorimetric detection technology for analysis of antibody 

titer and avidity as a test for discrimination resent HIV infection from past and new incidence sera panel for assay validation. 

Completed:

Grant N0 1R43AI064988-01and 2R44AI064988-02 “ Peptide-Based Serological Test for Cysticercosis”

Performance period: 4/01/2005-7/31/08

Role: PI

Summary: Development of a serological test for Cysticercosis in a ELISA format and rapid non-instrumental version with 

analytical sensitivity of the microplate ELISA

Grant SG348 

Title: Chromogenic system for rapid diagnostic tests

Agency: Maine Technology Institute 

Performance period: 03/18/2008- 09/08/2008

Role: PI

Previous:

Grant No. AI59329-01 (PI Andrew Levin)

Title: Identification of SARS Antigens for Serodiagnosis

Agency: National Institute of Allergy and Infectious Diseases/ National Institutes of Health

Performance Period: 4/01/04-3/31/06

Role: Principal Scientist

Grant No. HL65877 (Phase II, PI Andrew Levin)

Title: Rapid Assay for Bacterial Contamination of Platelets

Agency: National Heart, Lung and Blood Institute/National Institutes of Health

Performance Period: 10/01/02 – 8/31/06

Role: Principal Scientist 

Contract No. -00713

Title: Anthrax Serology Test

Agency: Centers for Disease Control, National Center for Infectious Diseases

Performance Period: 9/26/02 – 9/26/04

Role: Principal Scientist

Grant No. AI51926 (Phase I, PI Andrew Levin)

Title: Single Step Peptide ELISA for Lyme Serodiagnosis

Agency: National Institute of Allergy and Infectious Diseases/ National Institutes of Health

Performance Period: 3/15/02 – 3/14/04

Role: Principal Scientist

Biographical Sketches for each listed Senior/Key Person 3 Page 32

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Program Director/Principal Investigator (Last, First, Middle): Kovalenko, Victor A.

PHS 398/2590 (Rev. 11/07) Page Continuation Format Page

1990-1996 Palladin Institute of Biochemistry , Molecular Immunology Department , Academy of

Sciences of Ukraine, Kiev, Ukraine

Research Scientist

• Developed matrices to control separation and adhesion of antibodies and conducted a solid phase 

synthesis of immunovector molecules (immunotoxins, radiolabeled antibodies), evaluated conformational 

stability, immunological activity and in vitro toxicity of the conjugates. Conducted experiments on 

chemical modification of different polymer substrates and antibodies. 

• Researched chemistry of blood/cultured cell surface molecules by flow cytometry to establish 

targets/improve diagnostic methods. 

SELECTED PATENTS 

1. US Patent N 7628917, 2009. Porous Composite Membrane and Method for Making the Same”. Penezina 

OP, Pacheco M, Tsou D. 

2. USSR Patent N 1588137. New method for the synthesis of labeled antibodies. S.V. Komissarenko, G.N. 

Fomovskaya, O.P. Levchuk (O.P. Penezina), et.al. – 1988. 

SELECTED PUBLICATIONS

1. Penezina O., Clapham D., Collins J., et al. “New HIV peptide-based immunoassay resolves vaccineinduced seropositivity in HIV vaccine (phase III) trial participants”. Retrovirology 2012, 9(Suppl 2):P120 

2. Penezina O, Komissarenko S, Tishenco L, et al. Revealing some oncofetal antigens in peripheral blood 

mononuclear cells of donors and patients with B-chronic lymphocytic leukemia. LEUKEMIA RES 22: (11) 

1009-1013 NOV 1998 

3. Fomovskaya GN, Penezina OP, Goroshnikova TV, et al. Expression of some oncofetal antigens in 

peripheral mononuclear-cells of human and monkey exposed to low-doses of ionizing-radiation. EKSP 

ONKOL 16: (2-3) 

4. Davenport R, Haddock T, Penezina O, et al. L-selectin expression on peripheral blood leukocytes over 48 

hr. in stored blood. TRANSFUSION 38: (10) 17S, OCT 1998. 

5. Penezina OP, Fomovskaya GN, Haddock TF, et al. Changes in the dextran purified human blood 

leukocyte cell subsets content after filtration via polyester filters coated with immobilized Chondroitin 

Sulfate A. TRANSFUSION 39: (10) 41S-41S Suppl. S OCT 1999 

6. Penezina OP, Fomovskaia GN, Haddock TF, et al. Specific adhesion of human leukocytes to magnetic 

polystyrene beads, modified with Ca2+ independent ligands to L-selectin. FASEB J 11: (9) A1093 Suppl. 

S JUL 31 1997 

7. Davenport RD, Penezina OP. Cleavage of high molecular weight kininogen induced by filtration of 

platelet concentrates. TRANSFUSION 37: (9) S416-S416 Suppl. S SEP 1997 

8. Penezina OP. Fomovskaia GN. Haddock TF. Davenport RD. Partial dependence of human peripheral 

blood leukocyte binding to HMW fucoidan on divalent cations. UBZ,71(6):56-61, 1999 

9. Penezina OP, Fomovskaya GN, Haddock TF, et al. Specific adhesion to immobilized chondroitin sulfate 

A varies for different cell subsets of dextran purified human blood leukocytes. MOL BIOL CELL 9: 56A 

NOV 1998 

10. Oksana Penezina, Howard Neal, Navin Pathirana. “Proving the Suitability of Whatman Puradisc 

Syringe Filters for HPLC Sample Preparation Applications”. LCGC Europe, The Applications Book, July 

2006, page 82. 

Biographical Sketches for each listed Senior/Key Person 9 Page 50

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Program Director/Principal Investigator (Last, First, Middle): Kovalenko, Victor A.

PHS 398/2590 (Rev. 11/07) Page Continuation Format Page

SELECTED POSTER PRESENTATIONS. 

1. Penezina O., Clapham D., Collins J., et al. “New HIV peptide-based immunoassay resolves vaccineinduced seropositivity in HIV vaccine (phase III) trial participants”. AIDS Vaccine 2012, September 2012, 

Boston, MA 

2. Penezina O., Clapham D., Collins J., et al. “HIV Selectest: a new peptide-based enzyme immunoassay 

successfully distinguishes HIV vaccine-induced seropositivity from HIV infection in RV144, VAX003 and 

VAX004 vaccine trial participants”. XIX International AIDS Conference (AIDS 2012), July, 2012, 

Washington, D.C. 

3. Penezina O., Jose M. “Whatman nitrocellulose filterplates for chemiluminescent ELISA offer time, 

sensitivity and reagent-saving advantages over commonly used plastic 96-well microtiter plates”, 13th SBS, 

April, 2007, Montreal, Canada. 

4. Jose M, Penezina O. “Optimization of the Flow-through chemiluminescence ELISA protocol for

Whatman Protran chemiluminescence ELISA filterplate”, 13th SBS, April, 2007, Montreal, Canada. 

5. Penezina O., Neal H. “Whatman FTA Cards, designed for collection, transport, archiving and isolation 

of nucleic acids at room temperature, inactivate human immunodeficiency virus type 1(HIV-1) and 

BVDV(HCV model) virus.” 14th ISHEID, June, 2006, Toulon, France. 

6. Penezina O., Neal H. “Whatman FTA Cards, designed for collection, transport, archiving and isolation 

of nucleic acids at room temperature, inactivate human immunodeficiency virus type 1(HIV-1)”, 3rd IAS 

Conference on HIV Pathogenesis and Treatment, July, 2005, Rio de Janeiro, Brazil. 

7. Penezina O., Harvey M. “Evaluation of Human Immunodeficiency Virus Type I(HIV-1) Inactivation by 

Whatman FTA Elute Microcards”, XVII International AIDS Conference, August, 2008, Mexico City, 

Mexico.

8. Penezina O., Jose M., Harvey M. “FTA Elute Cards as Collection Devices for Blood, Urine and Saliva.” 

PITTCON, March, 2008, New Orleans, USA.

9. Penezina O., et. al. “Whatman FTA cards designed for collection, transport, archiving and isolation of 

nucleic acids at room temperature, preserve poliovirus type-2 viral RNA for up to 30 days at room 

temperature”. LabAutomation2007, Palm Springs, CA, January, 2007. 

SELECTED ORAL PRESENTATIONS.

1. Oksana Penezina, David Clapham, Kristen Hennessy, David Crane, Victor Kovalenko, Neil Krueger, 

Isaac R. Rodriguez-Chavez, Michael P. Busch and Andrew E. Levin "New HIV peptide-based immunoassay 

resolves vaccine induced seropositivity in HIV vaccine RV144 and HVTN204 trials", 2012 CDC HIV 

Diagnostics Conference December 12-14, 2012, Atlanta, GA. 

2. “New hydrophilization method of hydrophobic porous media”, ICOM2005 (International Congress on 

Membranes and Membrane Processes), Seoul, Korea, August, 2005. 

3. “New hydrophilization method for PVDF membrane”, NAMS 2004, Honolulu, HI, June, 2004. 

4. “The development of 95-well filterplate for DNA Sequencing reaction clean up”, NAMS 2001, 

Lexington, KY, May, 2001. 

5. “The development of 96-well ultrafiltration filterplates for genomics and proteomics applications.” The 

Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy, New Orleans, LA, March, 

2002: (PITTCON‘2002) 

6. “New Integrated Sample Preparation System for HPLC”, NAMS 2005 (North American Membrane 

Society Annual Meeting), Providence RI, June, 2005. 

Biographical Sketches for each listed Senior/Key Person 9 Page 51

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
* Last Name

RESEARCH & RELATED BUDGET - SECTION A & B, BUDGET PERIOD 1

* Budget Type:

Enter name of Organization:

* Start Date: * End Date:

* Project Role Base Salary ($)

* Fringe 

Benefits ($) * Funds Requested ($)

9.

8.

7.

6.

5.

4.

3.

2.

1.

Total Funds requested for all Senior Key Persons in the attached file

Total Senior/Key Person

Additional Senior Key Persons:

B. Other Personnel

A. Senior/Key Person

* Number of 

Personnel * Project Role

Acad. 

Months

Sum. 

Months

* Requested 

Salary ($)

Cal. 

Months

Post Doctoral Associates

Graduate Students

Undergraduate Students

Secretarial/Clerical

Total Number Other Personnel Total Other Personnel

Total Salary, Wages and Fringe Benefits (A+B)

Prefix * First Name Middle Name Suffix

* Fringe 

Benefits ($) * Funds Requested ($)

Acad. 

Months

Sum. 

Months

* Requested 

Salary ($)

Cal. 

Months

RESEARCH & RELATED Budget {A-B} (Funds Requested)

* ORGANIZATIONAL DUNS:

OMB Number: 4040-0001 

Expiration Date: 06/30/2011

Project Subaward/Consortium

5

Delete Entry

Dr. 7.20

Dr. 0.60

Dr. 7.20

Dr. 1.20

1 Research Assoc 6.00

1 Research Assoc 6.60

1 QA Associate 1.20

1 MFG Associate 1.80

1 Clinicial Trial Director 1.20

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Detailed Budget - Year 1 Page 52

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
C. Equipment Description

List items and dollar amount for each item exceeding $5,000

Equipment item * Funds Requested ($)

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11. Total funds requested for all equipment listed in the attached file

D. Travel

1. Domestic Travel Costs ( Incl. Canada, Mexico and U.S. Possessions)

2. Foreign Travel Costs

Total Travel Cost

Total Equipment

E. Participant/Trainee Support Costs

1. Tuition/Fees/Health Insurance

2. Stipends

3. Travel

4. Subsistence

5. Other

Number of Participants/Trainees Total Participant/Trainee Support Costs

Funds Requested ($)

Funds Requested ($)

RESEARCH & RELATED Budget {C-E} (Funds Requested)

RESEARCH & RELATED BUDGET - SECTION C, D, & E, BUDGET PERIOD 1

* Budget Type:

Enter name of Organization:

* Start Date: * End Date:

Additional Equipment:

* ORGANIZATIONAL DUNS:

Project Subaward/Consortium

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Detailed Budget - Year 1 Page 53

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
F. Other Direct Costs

1. Materials and Supplies

2. Publication Costs

3. Consultant Services

4. ADP/Computer Services

5. Subawards/Consortium/Contractual Costs

6. Equipment or Facility Rental/User Fees

7. Alterations and Renovations

8.

9.

10.

Total Other Direct Costs

G. Direct Costs

Total Direct Costs (A thru F)

H. Indirect Costs Indirect Cost 

Rate (%)

Indirect Cost 

Base ($)

1.

2.

3.

4.

Cognizant Federal Agency

I. Total Direct and Indirect Costs

Total Direct and Indirect Institutional Costs (G + H)

J. Fee

K. * Budget Justification

Indirect Cost Type

Funds Requested ($)

Funds Requested ($)

* Funds Requested ($)

Funds Requested ($)

Funds Requested ($)

RESEARCH & RELATED Budget {F-K} (Funds Requested)

Total Indirect Costs

(Only attach one file.)

(Agency Name, POC Name, and POC Phone Number)

Modified Total Direct Cost_

Modified Total Direct CostModified Total Direct CostModified Total Direct Cost_

RESEARCH & RELATED BUDGET - SECTION F-K, BUDGET PERIOD 1

* Budget Type:

Enter name of Organization:

* Start Date: * End Date:

* ORGANIZATIONAL DUNS:

Project Subaward/Consortium

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Detailed Budget - Year 1 Page 54

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
* Last Name

RESEARCH & RELATED BUDGET - SECTION A & B, BUDGET PERIOD 2

* Budget Type:

Enter name of Organization:

* Start Date: * End Date:

* Project Role Base Salary ($)

* Fringe 

Benefits ($) * Funds Requested ($)

9.

8.

7.

6.

5.

4.

3.

2.

1.

Total Funds requested for all Senior Key Persons in the attached file

Total Senior/Key Person

Additional Senior Key Persons:

B. Other Personnel

A. Senior/Key Person

* Number of 

Personnel * Project Role

Acad. 

Months

Sum. 

Months

* Requested 

Salary ($)

Cal. 

Months

Post Doctoral Associates

Graduate Students

Undergraduate Students

Secretarial/Clerical

Total Number Other Personnel Total Other Personnel

Total Salary, Wages and Fringe Benefits (A+B)

Prefix * First Name Middle Name Suffix

* Fringe 

Benefits ($) * Funds Requested ($)

Acad. 

Months

Sum. 

Months

* Requested 

Salary ($)

Cal. 

Months

RESEARCH & RELATED Budget {A-B} (Funds Requested)

* ORGANIZATIONAL DUNS:

OMB Number: 4040-0001 

Expiration Date: 06/30/2011

Project Subaward/Consortium

5

Delete Entry

Dr. PD/PI 7.20

Dr. Scientific Director 0.60

Dr. Senior Scientist 7.20

Dr. Project Leader 1.20

1 Research Associate 6.00

1 Research Associate 6.60

1 QA Associate 1.20

1 MFG Associate 1.80

1 Clincial Trial Director 0.60

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Detailed Budget - Year 2 Page 55

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
C. Equipment Description

List items and dollar amount for each item exceeding $5,000

Equipment item * Funds Requested ($)

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11. Total funds requested for all equipment listed in the attached file

D. Travel

1. Domestic Travel Costs ( Incl. Canada, Mexico and U.S. Possessions)

2. Foreign Travel Costs

Total Travel Cost

Total Equipment

E. Participant/Trainee Support Costs

1. Tuition/Fees/Health Insurance

2. Stipends

3. Travel

4. Subsistence

5. Other

Number of Participants/Trainees Total Participant/Trainee Support Costs

Funds Requested ($)

Funds Requested ($)

RESEARCH & RELATED Budget {C-E} (Funds Requested)

RESEARCH & RELATED BUDGET - SECTION C, D, & E, BUDGET PERIOD 2

* Budget Type:

Enter name of Organization:

* Start Date: * End Date:

Additional Equipment:

* ORGANIZATIONAL DUNS:

Project Subaward/Consortium

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Detailed Budget - Year 2 Page 56

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
F. Other Direct Costs

1. Materials and Supplies

2. Publication Costs

3. Consultant Services

4. ADP/Computer Services

5. Subawards/Consortium/Contractual Costs

6. Equipment or Facility Rental/User Fees

7. Alterations and Renovations

8.

9.

10.

Total Other Direct Costs

G. Direct Costs

Total Direct Costs (A thru F)

H. Indirect Costs Indirect Cost 

Rate (%)

Indirect Cost 

Base ($)

1.

2.

3.

4.

Cognizant Federal Agency

I. Total Direct and Indirect Costs

Total Direct and Indirect Institutional Costs (G + H)

J. Fee

K. * Budget Justification

Indirect Cost Type

Funds Requested ($)

Funds Requested ($)

* Funds Requested ($)

Funds Requested ($)

Funds Requested ($)

RESEARCH & RELATED Budget {F-K} (Funds Requested)

Total Indirect Costs

(Only attach one file.)

(Agency Name, POC Name, and POC Phone Number)

Modified Total Direct CostsModified Total Direct CostsModified Total Direct CostsModified Total Direct CostRESEARCH & RELATED BUDGET - SECTION F-K, BUDGET PERIOD 2

* Budget Type:

Enter name of Organization:

* Start Date: * End Date:

* ORGANIZATIONAL DUNS:

Project Subaward/Consortium

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Detailed Budget - Year 2 Page 57

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
* Last Name

RESEARCH & RELATED BUDGET - SECTION A & B, BUDGET PERIOD 3

* Budget Type:

Enter name of Organization:

* Start Date: * End Date:

* Project Role Base Salary ($)

* Fringe 

Benefits ($) * Funds Requested ($)

9.

8.

7.

6.

5.

4.

3.

2.

1.

Total Funds requested for all Senior Key Persons in the attached file

Total Senior/Key Person

Additional Senior Key Persons:

B. Other Personnel

A. Senior/Key Person

* Number of 

Personnel * Project Role

Acad. 

Months

Sum. 

Months

* Requested 

Salary ($)

Cal. 

Months

Post Doctoral Associates

Graduate Students

Undergraduate Students

Secretarial/Clerical

Total Number Other Personnel Total Other Personnel

Total Salary, Wages and Fringe Benefits (A+B)

Prefix * First Name Middle Name Suffix

* Fringe 

Benefits ($) * Funds Requested ($)

Acad. 

Months

Sum. 

Months

* Requested 

Salary ($)

Cal. 

Months

RESEARCH & RELATED Budget {A-B} (Funds Requested)

* ORGANIZATIONAL DUNS:

OMB Number: 4040-0001 

Expiration Date: 06/30/2011

Project Subaward/Consortium

4

Delete Entry

PD/PI 7.20

Scientific Director 0.60

Sr. Scientist 7.20

Project Leader 1.20

1 Research Associate 6.00

1 Research Associate 6.60

1 QA Associate 1.20

1 MFG Associate 1.80

07/01/2016 06/30/2017 Budget Period 

Add Attachment Delete Attachment View Attachment

Previous Period

3

	


 		

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Detailed Budget - Year 3 Page 58

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
C. Equipment Description

List items and dollar amount for each item exceeding $5,000

Equipment item * Funds Requested ($)

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11. Total funds requested for all equipment listed in the attached file

D. Travel

1. Domestic Travel Costs ( Incl. Canada, Mexico and U.S. Possessions)

2. Foreign Travel Costs

Total Travel Cost

Total Equipment

E. Participant/Trainee Support Costs

1. Tuition/Fees/Health Insurance

2. Stipends

3. Travel

4. Subsistence

5. Other

Number of Participants/Trainees Total Participant/Trainee Support Costs

Funds Requested ($)

Funds Requested ($)

RESEARCH & RELATED Budget {C-E} (Funds Requested)

RESEARCH & RELATED BUDGET - SECTION C, D, & E, BUDGET PERIOD 3

* Budget Type:

Enter name of Organization:

* Start Date: * End Date:

Additional Equipment:

* ORGANIZATIONAL DUNS:

Project Subaward/Consortium

07/01/2016 06/30/2017

Add Attachment Delete Attachment View Attachment

Budget Period 3 Delete Entry

	


 		

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Detailed Budget - Year 3 Page 59

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
F. Other Direct Costs

1. Materials and Supplies

2. Publication Costs

3. Consultant Services

4. ADP/Computer Services

5. Subawards/Consortium/Contractual Costs

6. Equipment or Facility Rental/User Fees

7. Alterations and Renovations

8.

9.

10.

Total Other Direct Costs

G. Direct Costs

Total Direct Costs (A thru F)

H. Indirect Costs Indirect Cost 

Rate (%)

Indirect Cost 

Base ($)

1.

2.

3.

4.

Cognizant Federal Agency

I. Total Direct and Indirect Costs

Total Direct and Indirect Institutional Costs (G + H)

J. Fee

K. * Budget Justification

Indirect Cost Type

Funds Requested ($)

Funds Requested ($)

* Funds Requested ($)

Funds Requested ($)

Funds Requested ($)

RESEARCH & RELATED Budget {F-K} (Funds Requested)

Total Indirect Costs

(Only attach one file.)

(Agency Name, POC Name, and POC Phone Number)

Modified Total Direct CostsModified Total Direct CostsModified Total Direct CostModified Total Direct CostRESEARCH & RELATED BUDGET - SECTION F-K, BUDGET PERIOD 3

* Budget Type:

Enter name of Organization:

* Start Date: * End Date:

* ORGANIZATIONAL DUNS:

Project Subaward/Consortium

07/01/2016 06/30/2017 Budget Period 3

Add Attachment Delete Attachment View Attachment

Next Period

Delete Entry

	


 		

 !""

Detailed Budget - Year 3 Page 60

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
BUDGET JUSTIFICATION – IMMUNETICS

Patricia Garrett, Ph.D. (Principal Investigator, Immunetics), 60% effort (7.2 cm)

Dr. Garrett has 25 years of experience in HIV diagnostics and has worked extensively in HIV incidence, in 

particular. She is the originator of the concept for the Phase I grant in progress, and was the PI until a 

management change at SeraCare resulted in her transition to a consultant role there earlier this year. She is 

skilled in project design and management, has been principal investigator or co-principal investigator on four 

other grants and contracts, and has published and presented widely on topics related to infectious disease 

diagnostics, method evaluation, and quality control. She has worked with this project team for more than a 

year, fostered good working relationships among team members and excellent progress on the grant work, and 

will be responsible for all aspects of the project.

Andrew E. Levin, Ph.D. (Scientific Director, Immunetics), 5% effort (0.6 cm)

Dr. Levin will provide overall coordination and guidance for the work to be carried out at Immunetics. He has 

extensive experience in diagnostic assay development and has served as PI on a number of previous 

infectious disease assay projects. Dr. Levin will coordinate work with Diagnostic Innovations, Diagnostic 

Consulting Network and with clinical collaborators at CDC, MHRP, and BSRI as needed with respect to 

acquisition and serological testing of human serum samples. He will analyze assay data for performance of the

rapid test with respect to sensitivity, specificity, and other parameters, which is a prerequisite to further

development by Dr. Kovalenko and partner company Diagnostic Innovations. Dr. Levin will be responsible 

for the Immunetics component in reports to NIH, in scientific publications, and in presentations at other venues.

Victor A. Kovalenko, PhD (Senior Scientist), 60% effort (7.2 cm)

Dr. Kovalenko as the inventor of the new rapid test technology which is the subject of this application will 

provide overall scientific leadership for the project. With his extensive experience in numerous areas of 

analytical biochemistry, bioorganic chemistry, diagnostic reagent and infectious disease assay development, 

he has served as principal scientist on a number of grants and as PI on a recent immunodiagnostics grant. He 

will assist in generating scientific reports for publications or presentation.

, Ph.D. (Project Leader), 10% effort (1.2 cm)

Dr. will be the primary scientist responsible for carrying out laboratory evaluations of the HIV rapid 

test at Immunetics on serum samples acquired from collaborators and internally, determining 

quantitative performance characteristics, investigating and analyzing deviations from performance targets,

running ELISA and Western Blot assays to characterize samples and for comparison with the rapid 

test, analyzing comparative assay performance qualitatively and quantitatively, and overseeing

documentation of laboratory work and compliance with Quality Systems Regulations (GMP). Dr. has

over 15 years of experience in development of in vitro diagnostic products in both public and private sector

organizations, including 5 years focused on membrane assay development and validation, directly relevant to 

the present project. 

Quality Assurance Associate, 10% effort (1.2 cm)

A QA Associate at Immunetics will provide about 4 hours of effort per week to ensure that the project is 

documented in accordance with Immunetics Quality System and Design Control requirements, and to audit 

laboratory and clinical records as needed. 

 Research Associate, 50% effort (6.0 cm)

The Research Associate will be responsible for carrying out reagent syntheses for assay development, 

evaluations of the HIV rapid test at Immunetics on serum samples acquired from CDC, MHRP and BSRI or 

internally, determining qualitative and quantitative performance characteristics, investigating and analyzing 

deviations from performance targets, running ELISA and Western Blot assays to characterize samples and for 

comparison with the rapid test, documentation of laboratory work and compliance with Quality Systems 

Regulations (GMP).

Budget Justification Page 61

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
 Research Associate, 55% effort (6.6cm)

A Research Associate at Immunetics will support the Senior Scientist (Dr. with about 20 hours of 

effort per week in year 1, during which most of the assay development work will be carried out requiring 

intensive testing of serum samples under various experimental conditions, both on rapid test prototypes and on 

other incidence ELISAs, conventional ELISAs and Western Blot assays. The Research Associate will perform 

assays, document and interpret results, and provide general laboratory assistance. 

 MT (ASCP), MPH (Director, Clinical Affairs), 1.2 cm

 is Immunetics’ Director of Clinical Affairs and is responsible for all aspects of design, monitoring, 

and compliance for clinical studies. Prior to joining Immunetics, was Director of Clinical Research at 

 Corporation overseeing all activities related to clinical research studies. She has over 20 years of 

experience in clinical affairs management, including regulatory affairs and quality assurance. Her experience 

includes medical device, pharmaceutical, and academic arenas in the therapeutic areas of diabetes, 

anesthesiology, oncology and dermatology. 

Consultants

- Statistical Analyst

There are no funds requested for the first year.

Total Year 1 Direct Cost: 

Consortium

Diagnostic Innovations (DI). will maintain a 20% effort at Diagnostic Innovations, coordinating 

project development activities performed at this facility. Diagnostic Innovations will concentrate on developing 

conjugates and the enzyme label detection system, substrate and test strip components which are the key 

elements of the HIV rapid test. Tasks will specifically include synthesis of colorimetric detection system

reagents and peptide conjugates, development of stabilization chemistry for all diagnostic strip components,

assay format optimization and diagnostic cassette design. Following completion of an optimized prototype 

rapid test, DI will provide formulations, protocols and documentation for manufacture of bulk reagents 

and test strip manufacture.

Total Year 1 Direct Cost: $

will oversee design and engineering of the proposed assay. will perform manufacturing 

procedures (impregnation, dispensing, drying, lamination, cutting, assembly) of the diagnostic cassette 

components, including the test strip, dried reagent pad, and flow cell housing. Quality control of HIV rapid test 

kits will be performed at the component level. Further details are described in the Consortium 

Arrangements section.

Total Year 1 Direct Cost: $

Blood Systems Research Institute. 

BSRI as the research division of Blood Systems, Inc. has been a leader in investigations of new blood 

screening technologies and the development of new regulatory and industry policies for blood screening and 

donor management. The work at BSRI will be overseen by is an expert on HIV 

incidence testing and has an extensive history of involvement in major studies of every pathogen affecting 

blood safety over the past several decades. The study of HIV incidence involving comparison of whole blood vs 

plasma proposed in this project will be managed 

Total Year 1 Direct Cost: $ 

Other:

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Controls from SeraCare. 

SeraCare will provide HIV serum or plasma controls for use with the HIV rapid incidence test. 

Shipping

Reimbursement is requested for shipping costs for shipping of samples and rapid test kits (

Total Year 1 Cost: $

Equipment

None.

Total Year 1 Cost: $

Travel

Travel for Principal Investigator and one scientist to one national meeting (e.g., American Society of 

Microbiology, CDC Emerging Infectious Diseases) per year is requested 

Total Year 1 Cost: $

Fringe

Fringe benefits are calculated at the rate of as approved by NIH DFAS. 

Total Year 1 Cost: $

Indirect Cost (F&A)

Indirect costs are charged at Immunetics’ DFAS-approved F&A rate of .

Total Year 1 Cost: $

Budget Justification Page 63

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Section A, Senior/Key Person

Section C, Equipment

RESEARCH & RELATED BUDGET - Cumulative Budget

Section D, Travel

Domestic

Section E, Participant/Trainee Support Costs

Foreign

Tuition/Fees/Health Insurance

Stipends

Travel

Subsistence

Other

Number of Participants/Trainees

1.

2.

3.

4.

5.

6.

1.

2.

Section F, Other Direct Costs

1. Materials and Supplies

2. Publication Costs

3. Consultant Services

4. ADP/Computer Services

5. Subawards/Consortium/Contractual Costs

6. Equipment or Facility Rental/User Fees

7. Alterations and Renovations

8.

9.

10.

Totals ($)

Total Number Other Personnel

Total Salary, Wages and Fringe Benefits (A+B)

Other 1

Other 2

Other 3

Section B, Other Personnel

Section J, Fee

Section I, Total Direct and Indirect Costs (G + H)

Section H, Indirect Costs

Section G, Direct Costs (A thru F)

14

	


 		

 !""

Cumulative Budget Page 64

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTION A & B, BUDGET PERIOD 1

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2014 * End Date: 06-30-2015 Budget Period: 1

A. Senior/Key Person

Prefix * First Name Middle Name * Last Name Suffix * Project Role Base Salary

($)

Cal.

Months

Acad.

Months

Sum.

Months

* Requested

Salary ($)

* Fringe

Benefits ($)

* Funds Requested ($)

1. MD PD/PI 0.60

Total Funds Requested for all Senior Key Persons in the attached file

Additional Senior Key Persons: File Name: Mime Type: Total Senior/Key Person

B. Other Personnel

* Number of

Personnel

* Project Role Cal.

Months

Acad.

Months

Sum.

Months

* Requested

Salary ($)

* Fringe

Benefits

* Funds Requested

($)

Post Doctoral Associates

Graduate Students

Undergraduate Students

Secretarial/Clerical

1 Staff Scientist II 0.60

1 Research Associate II 1.50

2 Total Number Other Personnel Total Other Personnel

Total Salary, Wages and Fringe Benefits (A+B)

RESEARCH & RELATED Budget {A-B} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 1 Page 65

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTION C, D, & E, BUDGET PERIOD 1

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2014 * End Date: 06-30-2015 Budget Period: 1

C. Equipment Description

List items and dollar amount for each item exceeding $5,000

Equipment Item * Funds Requested ($)

Total funds requested for all equipment listed in the attached file

Total Equipment

Additional Equipment: File Name: Mime Type:

D. Travel Funds Requested ($)

1. Domestic Travel Costs ( Incl. Canada, Mexico, and U.S. Possessions)

2. Foreign Travel Costs

Total Travel Cost

E. Participant/Trainee Support Costs Funds Requested ($)

1. Tuition/Fees/Health Insurance

2. Stipends

3. Travel

4. Subsistence

5. Other:

Number of Participants/Trainees Total Participant/Trainee Support Costs

RESEARCH & RELATED Budget {C-E} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 1 Page 66

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTIONS F-K, BUDGET PERIOD 1

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2014 * End Date: 06-30-2015 Budget Period: 1

F. Other Direct Costs Funds Requested ($)

1. Materials and Supplies

2. Publication Costs

3. Consultant Services

4. ADP/Computer Services

5. Subawards/Consortium/Contractual Costs

6. Equipment or Facility Rental/User Fees

7. Alterations and Renovations

Total Other Direct Costs

G. Direct Costs Funds Requested ($)

Total Direct Costs (A thru F)

H. Indirect Costs

Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) * Funds Requested ($)

1. MTDC

Total Indirect Costs

Cognizant Federal Agency

(Agency Name, POC Name, and POC Phone Number)

DHHS, DCA Western Field Office, Arif Karim, 415-437-7820

I. Total Direct and Indirect Costs Funds Requested ($)

Total Direct and Indirect Institutional Costs (G + H)

J. Fee Funds Requested ($)

K. * Budget Justification File Name: 1234-BSRI_Budget_Justification.pdf Mime Type: application/pdf

(Only attach one file.)

RESEARCH & RELATED Budget {F-K} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 1 Page 67

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTION A & B, BUDGET PERIOD 2

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2015 * End Date: 06-30-2016 Budget Period: 2

A. Senior/Key Person

Prefix * First Name Middle Name * Last Name Suffix * Project Role Base Salary

($)

Cal.

Months

Acad.

Months

Sum.

Months

* Requested

Salary ($)

* Fringe

Benefits ($)

* Funds Requested ($)

1. MD PD/PI 0.60

Total Funds Requested for all Senior Key Persons in the attached file

Additional Senior Key Persons: File Name: Mime Type: Total Senior/Key Person

B. Other Personnel

* Number of

Personnel

* Project Role Cal.

Months

Acad.

Months

Sum.

Months

* Requested

Salary ($)

* Fringe

Benefits

* Funds Requested

($)

Post Doctoral Associates

Graduate Students

Undergraduate Students

Secretarial/Clerical

1 Staff Scientist II 0.60

1 Research Associate II 1.50

2 Total Number Other Personnel Total Other Personnel

Total Salary, Wages and Fringe Benefits (A+B)

RESEARCH & RELATED Budget {A-B} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 1 Page 68

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTION C, D, & E, BUDGET PERIOD 2

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2015 * End Date: 06-30-2016 Budget Period: 2

C. Equipment Description

List items and dollar amount for each item exceeding $5,000

Equipment Item * Funds Requested ($)

Total funds requested for all equipment listed in the attached file

Total Equipment

Additional Equipment: File Name: Mime Type:

D. Travel Funds Requested ($)

1. Domestic Travel Costs ( Incl. Canada, Mexico, and U.S. Possessions)

2. Foreign Travel Costs

Total Travel Cost

E. Participant/Trainee Support Costs Funds Requested ($)

1. Tuition/Fees/Health Insurance

2. Stipends

3. Travel

4. Subsistence

5. Other:

Number of Participants/Trainees Total Participant/Trainee Support Costs

RESEARCH & RELATED Budget {C-E} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 1 Page 69

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTIONS F-K, BUDGET PERIOD 2

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2015 * End Date: 06-30-2016 Budget Period: 2

F. Other Direct Costs Funds Requested ($)

Total Other Direct Costs

G. Direct Costs Funds Requested ($)

Total Direct Costs (A thru F) 27,894.00

H. Indirect Costs

Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) * Funds Requested ($)

1. MTDC

Total Indirect Costs

Cognizant Federal Agency

(Agency Name, POC Name, and POC Phone Number)

DHHS, DCA Western Field Office, Arif Karim,

I. Total Direct and Indirect Costs Funds Requested ($)

Total Direct and Indirect Institutional Costs (G + H)

J. Fee Funds Requested ($)

K. * Budget Justification File Name: Mime Type: application/pdf

(Only attach one file.)

RESEARCH & RELATED Budget {F-K} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 1 Page 70

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTION A & B, BUDGET PERIOD 3

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2016 * End Date: 06-30-2017 Budget Period: 3

A. Senior/Key Person

Prefix * First Name Middle Name * Last Name Suffix * Project Role Base Salary

($)

Cal.

Months

Acad.

Months

Sum.

Months

* Requested

Salary ($)

* Fringe

Benefits ($)

* Funds Requested ($)

1. MD PD/PI 0.60

Total Funds Requested for all Senior Key Persons in the attached file

Additional Senior Key Persons: File Name: Mime Type: Total Senior/Key Person

B. Other Personnel

* Number of

Personnel

* Project Role Cal.

Months

Acad.

Months

Sum.

Months

* Requested

Salary ($)

* Fringe

Benefits

* Funds Requested

($)

Post Doctoral Associates

Graduate Students

Undergraduate Students

Secretarial/Clerical

0 Total Number Other Personnel Total Other Personnel

Total Salary, Wages and Fringe Benefits (A+B)

RESEARCH & RELATED Budget {A-B} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 1 Page 71

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTION C, D, & E, BUDGET PERIOD 3

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2016 * End Date: 06-30-2017 Budget Period: 3

C. Equipment Description

List items and dollar amount for each item exceeding $5,000

Equipment Item * Funds Requested ($)

Total funds requested for all equipment listed in the attached file

Total Equipment

Additional Equipment: File Name: Mime Type:

D. Travel Funds Requested ($)

1. Domestic Travel Costs ( Incl. Canada, Mexico, and U.S. Possessions)

2. Foreign Travel Costs

Total Travel Cost

E. Participant/Trainee Support Costs Funds Requested ($)

1. Tuition/Fees/Health Insurance

2. Stipends

3. Travel

4. Subsistence

5. Other:

Number of Participants/Trainees Total Participant/Trainee Support Costs

RESEARCH & RELATED Budget {C-E} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 1 Page 72

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTIONS F-K, BUDGET PERIOD 3

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2016 * End Date: 06-30-2017 Budget Period: 3

F. Other Direct Costs Funds Requested ($)

Total Other Direct Costs

G. Direct Costs Funds Requested ($)

Total Direct Costs (A thru F)

H. Indirect Costs

Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) * Funds Requested ($)

1. MTDC

Total Indirect Costs

Cognizant Federal Agency

(Agency Name, POC Name, and POC Phone Number)

DHHS, DCA Western Field Office, Arif Karim,

I. Total Direct and Indirect Costs Funds Requested ($)

Total Direct and Indirect Institutional Costs (G + H)

J. Fee Funds Requested ($)

K. * Budget Justification File Name: 1234-BSRI_Budget_Justification.pdf Mime Type: application/pdf

(Only attach one file.)

RESEARCH & RELATED Budget {F-K} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 1 Page 73

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - Cumulative Budget

Totals ($)

Section A, Senior/Key Person

Section B, Other Personnel

Total Number Other Personnel 4

Total Salary, Wages and Fringe Benefits (A+B)

Section C, Equipment

Section D, Travel

1. Domestic

2. Foreign

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 1 Page 74

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Budget Justification

Personnel

Consortium Principal Investigator for the project will oversee the work performed 

at will provide intellectual input to the project both in the technical performance of the work and the 

interpretation of the results. He will attend the management and advisory meetings, as necessary. 

will contribute 0.6 calendar months to the project each year.

Staff Scientist II and Manager of the Core Immunology Laboratory (CIL) at will 

provide scientific support and guidance to the research associate performing the work in the CIL, will assist in 

the preparation of standard SOPs for the work, and analyze results. Dr. will provide 0.6 calendar 

months effort during Years 1 and 2.

, Research Associate II, has 13 years’ experience performing various incidence assays. She 

will be responsible for receiving, subaliquoting, cataloging (using a Freezerworks specimen management 

program/system) all samples that will be tested and will perform incidence assays at as directed by the 

study group. will devote 0.15 calendar months to the project during Years 1 and 2.

Fringe benefits are calculated at our federally-negotiated rate of 

Materials and Supplies

During Year 1, $ has been budgeted for the purchase of disposables, including gloves and tips.

Subaward 1 Budget Justification Attachment Page 75

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTION A & B, BUDGET PERIOD 1

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2014 * End Date: 06-30-2015 Budget Period: 1

A. Senior/Key Person

Prefix * First Name Middle Name * Last Name Suffix * Project Role Base Salary

($)

Cal.

Months

Acad.

Months

Sum.

Months

* Requested

Salary ($)

* Fringe

Benefits ($)

* Funds Requested ($)

1. PhD Other Investigator 0.60

Total Funds Requested for all Senior Key Persons in the attached file

Additional Senior Key Persons: File Name: Mime Type: Total Senior/Key Person

B. Other Personnel

* Number of

Personnel

* Project Role Cal.

Months

Acad.

Months

Sum.

Months

* Requested

Salary ($)

* Fringe

Benefits

* Funds Requested

($)

Post Doctoral Associates

Graduate Students

Undergraduate Students

Secretarial/Clerical

1 Scientist 1.20

1 Associate Scientist 1.20

1 Laboratory Assistant 1.20

1 Design Engineer 1.20

4 Total Number Other Personnel Total Other Personnel

Total Salary, Wages and Fringe Benefits (A+B)

RESEARCH & RELATED Budget {A-B} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 2 Page 76

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTION C, D, & E, BUDGET PERIOD 1

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2014 * End Date: 06-30-2015 Budget Period: 1

C. Equipment Description

List items and dollar amount for each item exceeding $5,000

Equipment Item * Funds Requested ($)

Total funds requested for all equipment listed in the attached file

Total Equipment

Additional Equipment: File Name: Mime Type:

D. Travel Funds Requested ($)

1. Domestic Travel Costs ( Incl. Canada, Mexico, and U.S. Possessions)

2. Foreign Travel Costs

Total Travel Cost

E. Participant/Trainee Support Costs Funds Requested ($)

1. Tuition/Fees/Health Insurance

2. Stipends

3. Travel

4. Subsistence

5. Other:

Number of Participants/Trainees Total Participant/Trainee Support Costs

RESEARCH & RELATED Budget {C-E} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 2 Page 77

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTIONS F-K, BUDGET PERIOD 1

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2014 * End Date: 06-30-2015 Budget Period: 1

F. Other Direct Costs Funds Requested ($)

1. Materials and Supplies

2. Publication Costs

3. Consultant Services

4. ADP/Computer Services

5. Subawards/Consortium/Contractual Costs

6. Equipment or Facility Rental/User Fees

7. Alterations and Renovations

Total Other Direct Costs

G. Direct Costs Funds Requested ($)

Total Direct Costs (A thru F)

H. Indirect Costs

Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) * Funds Requested ($)

1. Facilities, Overhead

Total Indirect Costs

Cognizant Federal Agency

(Agency Name, POC Name, and POC Phone Number)

None

I. Total Direct and Indirect Costs Funds Requested ($)

Total Direct and Indirect Institutional Costs (G + H)

J. Fee Funds Requested ($)

K. * Budget Justification File Name: Mime Type: application/pdf

(Only attach one file.)

RESEARCH & RELATED Budget {F-K} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 2 Page 78

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTION A & B, BUDGET PERIOD 2

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2015 * End Date: 06-30-2016 Budget Period: 2

A. Senior/Key Person

Prefix * First Name Middle Name * Last Name Suffix * Project Role Base Salary

($)

Cal.

Months

Acad.

Months

Sum.

Months

* Requested

Salary ($)

* Fringe

Benefits ($)

* Funds Requested ($)

1. PhD Other Investigator 0.60

Total Funds Requested for all Senior Key Persons in the attached file

Additional Senior Key Persons: File Name: Mime Type: Total Senior/Key Person

B. Other Personnel

* Number of

Personnel

* Project Role Cal.

Months

Acad.

Months

Sum.

Months

* Requested

Salary ($)

* Fringe

Benefits

* Funds Requested

($)

Post Doctoral Associates

Graduate Students

Undergraduate Students

Secretarial/Clerical

1 Scientist 1.20

1 Research Associate 1.20

1 Research Assistant 1.20

1 Design Engineer 1.20

4 Total Number Other Personnel Total Other Personnel

Total Salary, Wages and Fringe Benefits (A+B)

RESEARCH & RELATED Budget {A-B} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 2 Page 79

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTION C, D, & E, BUDGET PERIOD 2

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2015 * End Date: 06-30-2016 Budget Period: 2

C. Equipment Description

List items and dollar amount for each item exceeding $5,000

Equipment Item * Funds Requested ($)

Total funds requested for all equipment listed in the attached file

Total Equipment

Additional Equipment: File Name: Mime Type:

D. Travel Funds Requested ($)

1. Domestic Travel Costs ( Incl. Canada, Mexico, and U.S. Possessions)

2. Foreign Travel Costs

Total Travel Cost

E. Participant/Trainee Support Costs Funds Requested ($)

1. Tuition/Fees/Health Insurance

2. Stipends

3. Travel

4. Subsistence

5. Other:

Number of Participants/Trainees Total Participant/Trainee Support Costs

RESEARCH & RELATED Budget {C-E} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 2 Page 80

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTIONS F-K, BUDGET PERIOD 2

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2015 * End Date: 06-30-2016 Budget Period: 2

F. Other Direct Costs Funds Requested ($)

1. Materials and Supplies

2. Publication Costs

3. Consultant Services

4. ADP/Computer Services

5. Subawards/Consortium/Contractual Costs

6. Equipment or Facility Rental/User Fees

7. Alterations and Renovations

Total Other Direct Costs

G. Direct Costs Funds Requested ($)

Total Direct Costs (A thru F)

H. Indirect Costs

Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) * Funds Requested ($)

1. Facilities, Overhead

Total Indirect Costs

Cognizant Federal Agency

(Agency Name, POC Name, and POC Phone Number)

None

I. Total Direct and Indirect Costs Funds Requested ($)

Total Direct and Indirect Institutional Costs (G + H)

J. Fee Funds Requested ($)

K. * Budget Justification File Name: Mime Type: application/pdf

(Only attach one file.)

RESEARCH & RELATED Budget {F-K} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 2 Page 81

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTION A & B, BUDGET PERIOD 3

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2016 * End Date: 06-30-2017 Budget Period: 3

A. Senior/Key Person

Prefix * First Name Middle Name * Last Name Suffix * Project Role Base Salary

($)

Cal.

Months

Acad.

Months

Sum.

Months

* Requested

Salary ($)

* Fringe

Benefits ($)

* Funds Requested ($)

1. PhD Other Investigator 0.60

Total Funds Requested for all Senior Key Persons in the attached file

Additional Senior Key Persons: File Name: Mime Type: Total Senior/Key Person

B. Other Personnel

* Number of

Personnel

* Project Role Cal.

Months

Acad.

Months

Sum.

Months

* Requested

Salary ($)

* Fringe

Benefits

* Funds Requested

($)

Post Doctoral Associates

Graduate Students

Undergraduate Students

Secretarial/Clerical

1 Scientist 1.20

1 Research Associate 1.20

1 Research Assistant 1.20

1 Design Engineer 1.20

4 Total Number Other Personnel Total Other Personnel

Total Salary, Wages and Fringe Benefits (A+B)

RESEARCH & RELATED Budget {A-B} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 2 Page 82

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTION C, D, & E, BUDGET PERIOD 3

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2016 * End Date: 06-30-2017 Budget Period: 3

C. Equipment Description

List items and dollar amount for each item exceeding $5,000

Equipment Item * Funds Requested ($)

Total funds requested for all equipment listed in the attached file

Total Equipment

Additional Equipment: File Name: Mime Type:

D. Travel Funds Requested ($)

1. Domestic Travel Costs ( Incl. Canada, Mexico, and U.S. Possessions)

2. Foreign Travel Costs

Total Travel Cost

E. Participant/Trainee Support Costs Funds Requested ($)

1. Tuition/Fees/Health Insurance

2. Stipends

3. Travel

4. Subsistence

5. Other:

Number of Participants/Trainees Total Participant/Trainee Support Costs

RESEARCH & RELATED Budget {C-E} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 2 Page 83

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTIONS F-K, BUDGET PERIOD 3

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2016 * End Date: 06-30-2017 Budget Period: 3

F. Other Direct Costs Funds Requested ($)

1. Materials and Supplies

2. Publication Costs

3. Consultant Services

4. ADP/Computer Services

5. Subawards/Consortium/Contractual Costs

6. Equipment or Facility Rental/User Fees

7. Alterations and Renovations

Total Other Direct Costs

G. Direct Costs Funds Requested ($)

Total Direct Costs (A thru F)

H. Indirect Costs

Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) * Funds Requested ($)

1. Facilities, Overhead

Total Indirect Costs

Cognizant Federal Agency

(Agency Name, POC Name, and POC Phone Number)

None

I. Total Direct and Indirect Costs Funds Requested ($)

Total Direct and Indirect Institutional Costs (G + H)

J. Fee Funds Requested ($)

K. * Budget Justification File Name: Mime Type: application/pdf

(Only attach one file.)

RESEARCH & RELATED Budget {F-K} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 2 Page 84

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - Cumulative Budget

Totals ($)

Section A, Senior/Key Person

Section B, Other Personnel

Total Number Other Personnel 12

Total Salary, Wages and Fringe Benefits (A+B)

Section C, Equipment

Section D, Travel

1. Domestic

2. Foreign

Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 2 Page 85

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
BUDGET JUSTIFICATIONPersonnel

will serve as the Principal Investigator at (3 calendar years, 5% 

effort). His responsibilities include study design and supervision of research activities, review 

and interpretation of data, communications with Immunetics. 

Scientist_TBD, will serve as (3 calendar years, 10% effort). 

Oversight, planning and management of the program at liaison with Immunetics. 

Assoc. Scientist_TBD, will serve as (3 calendar years, 10% effort). 

Translation of documents provided to into spefications and SOPs. Validation of 

processes and equipment, technical troubleshooting, production of parts for evaluation at 

Immunetics. 

Lab Technician_TBD, will serve (3 calendar years, 10% effort) to carry out the laboratory 

work of the research project as per protocol under the guidance of the Principal Investigator. 

Design Engineer_TBD will serve (3 calendar years, 10% effort) 

Design and development of the cartridge for the Immunetics device, production of rapid 

prototype parts, design and implementation of the prototype mold. 

Supplies

Supplies to be purchased in year 1 will include: assay specific material, stereo-lithographic 

plastic parts, plastic parts for prototype mold, miscellaneous lab and computer supplies and 

services and shipping 

Total Year 1 Cost: $

Travel

Support for a trip to allow the two collaborating 

companies to discuss progress in face-to-face meeting per year is requested (travel plus 1 night 

lodging plus per diem) 

Total Year 1 Cost: $

Fringe

 fringe rate approved by DFAS is 

Indirect Cost (F&A)

 F&A rate approved by DFAS is 

Subaward 2 Budget Justification Attachment Page 86

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTION A & B, BUDGET PERIOD 1

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2014 * End Date: 06-30-2015 Budget Period: 1

A. Senior/Key Person

Prefix * First Name Middle Name * Last Name Suffix * Project Role Base Salary

($)

Cal.

Months

Acad.

Months

Sum.

Months

* Requested

Salary ($)

* Fringe

Benefits ($)

* Funds Requested ($)

1. PD/PI 4.20

Total Funds Requested for all Senior Key Persons in the attached file

Additional Senior Key Persons: File Name: Mime Type: Total Senior/Key Person

B. Other Personnel

* Number of

Personnel

* Project Role Cal.

Months

Acad.

Months

Sum.

Months

* Requested

Salary ($)

* Fringe

Benefits

* Funds Requested

($)

Post Doctoral Associates

Graduate Students

Undergraduate Students

Secretarial/Clerical

1 7.20

1 7.20

1 9.60

3 Total Number Other Personnel Total Other Personnel

Total Salary, Wages and Fringe Benefits (A+B)

RESEARCH & RELATED Budget {A-B} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 3 Page 87

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTION C, D, & E, BUDGET PERIOD 1

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2014 * End Date: 06-30-2015 Budget Period: 1

C. Equipment Description

List items and dollar amount for each item exceeding $5,000

Equipment Item * Funds Requested ($)

1. Virtis Advantage Plus Freeze Dryer XL,

2. Bio-Dot

Total funds requested for all equipment listed in the attached file

Total Equipment

Additional Equipment: File Name: Mime Type:

D. Travel Funds Requested ($)

1. Domestic Travel Costs ( Incl. Canada, Mexico, and U.S. Possessions)

2. Foreign Travel Costs

Total Travel Cost

E. Participant/Trainee Support Costs Funds Requested ($)

1. Tuition/Fees/Health Insurance

2. Stipends

3. Travel

4. Subsistence

5. Other:

Number of Participants/Trainees Total Participant/Trainee Support Costs

RESEARCH & RELATED Budget {C-E} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 3 Page 88

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTIONS F-K, BUDGET PERIOD 1

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2014 * End Date: 06-30-2015 Budget Period: 1

F. Other Direct Costs Funds Requested ($)

1. Materials and Supplies

2. Publication Costs

3. Consultant Services

4. ADP/Computer Services

5. Subawards/Consortium/Contractual Costs

6. Equipment or Facility Rental/User Fees

7. Alterations and Renovations

Total Other Direct Costs

G. Direct Costs Funds Requested ($)

Total Direct Costs (A thru F)

H. Indirect Costs

Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) * Funds Requested ($)

1. Total Direct Cost

Total Indirect Costs

Cognizant Federal Agency

(Agency Name, POC Name, and POC Phone Number)

I. Total Direct and Indirect Costs Funds Requested ($)

Total Direct and Indirect Institutional Costs (G + H)

J. Fee Funds Requested ($)

K. * Budget Justification File Name: Mime Type: application/pdf

(Only attach one file.)

RESEARCH & RELATED Budget {F-K} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 3 Page 89

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTION A & B, BUDGET PERIOD 2

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2015 * End Date: 06-30-2016 Budget Period: 2

A. Senior/Key Person

Prefix * First Name Middle Name * Last Name Suffix * Project Role Base Salary

($)

Cal.

Months

Acad.

Months

Sum.

Months

* Requested

Salary ($)

* Fringe

Benefits ($)

* Funds Requested ($)

1. PD/PI 4.20

Total Funds Requested for all Senior Key Persons in the attached file

Additional Senior Key Persons: File Name: Mime Type: Total Senior/Key Person

B. Other Personnel

* Number of

Personnel

* Project Role Cal.

Months

Acad.

Months

Sum.

Months

* Requested

Salary ($)

* Fringe

Benefits

* Funds Requested

($)

Post Doctoral Associates

Graduate Students

Undergraduate Students

Secretarial/Clerical

1 7.20

1 7.20

1 9.60

3 Total Number Other Personnel Total Other Personnel

Total Salary, Wages and Fringe Benefits (A+B)

RESEARCH & RELATED Budget {A-B} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 3 Page 90

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTION C, D, & E, BUDGET PERIOD 2

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2015 * End Date: 06-30-2016 Budget Period: 2

C. Equipment Description

List items and dollar amount for each item exceeding $5,000

Equipment Item * Funds Requested ($)

1. spectrophotometer (Shimadzu UV1800)

Total funds requested for all equipment listed in the attached file

Total Equipment

Additional Equipment: File Name: Mime Type:

D. Travel Funds Requested ($)

1. Domestic Travel Costs ( Incl. Canada, Mexico, and U.S. Possessions)

2. Foreign Travel Costs

Total Travel Cost

E. Participant/Trainee Support Costs Funds Requested ($)

1. Tuition/Fees/Health Insurance

2. Stipends

3. Travel

4. Subsistence

5. Other:

Number of Participants/Trainees Total Participant/Trainee Support Costs

RESEARCH & RELATED Budget {C-E} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 3 Page 91

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTIONS F-K, BUDGET PERIOD 2

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2015 * End Date: 06-30-2016 Budget Period: 2

F. Other Direct Costs Funds Requested ($)

1. Materials and Supplies

2. Publication Costs

3. Consultant Services

4. ADP/Computer Services

5. Subawards/Consortium/Contractual Costs

6. Equipment or Facility Rental/User Fees

7. Alterations and Renovations

Total Other Direct Costs

G. Direct Costs Funds Requested ($)

Total Direct Costs (A thru F)

H. Indirect Costs

Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) * Funds Requested ($)

1. Total Direct Cost

Total Indirect Costs

Cognizant Federal Agency

(Agency Name, POC Name, and POC Phone Number)

I. Total Direct and Indirect Costs Funds Requested ($)

Total Direct and Indirect Institutional Costs (G + H)

J. Fee Funds Requested ($)

K. * Budget Justification File Name: Mime Type: application/pdf

(Only attach one file.)

RESEARCH & RELATED Budget {F-K} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 3 Page 92

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTION A & B, BUDGET PERIOD 3

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2016 * End Date: 06-30-2017 Budget Period: 3

A. Senior/Key Person

Prefix * First Name Middle Name * Last Name Suffix * Project Role Base Salary

($)

Cal.

Months

Acad.

Months

Sum.

Months

* Requested

Salary ($)

* Fringe

Benefits ($)

* Funds Requested ($)

1. PD/PI 4.20

Total Funds Requested for all Senior Key Persons in the attached file

Additional Senior Key Persons: File Name: Mime Type: Total Senior/Key Person

B. Other Personnel

* Number of

Personnel

* Project Role Cal.

Months

Acad.

Months

Sum.

Months

* Requested

Salary ($)

* Fringe

Benefits

* Funds Requested

($)

Post Doctoral Associates

Graduate Students

Undergraduate Students

Secretarial/Clerical

1 7.20

1 7.20

1 9.60

3 Total Number Other Personnel Total Other Personnel

Total Salary, Wages and Fringe Benefits (A+B)

RESEARCH & RELATED Budget {A-B} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 3 Page 93

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTION C, D, & E, BUDGET PERIOD 3

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2016 * End Date: 06-30-2017 Budget Period: 3

C. Equipment Description

List items and dollar amount for each item exceeding $5,000

Equipment Item * Funds Requested ($)

Total funds requested for all equipment listed in the attached file

Total Equipment

Additional Equipment: File Name: Mime Type:

D. Travel Funds Requested ($)

1. Domestic Travel Costs ( Incl. Canada, Mexico, and U.S. Possessions)

2. Foreign Travel Costs

Total Travel Cost

E. Participant/Trainee Support Costs Funds Requested ($)

1. Tuition/Fees/Health Insurance

2. Stipends

3. Travel

4. Subsistence

5. Other:

Number of Participants/Trainees Total Participant/Trainee Support Costs

RESEARCH & RELATED Budget {C-E} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 3 Page 94

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - SECTIONS F-K, BUDGET PERIOD 3

* ORGANIZATIONAL DUNS:

* Budget Type: ❍ Project ● Subaward/Consortium

Enter name of Organization:

* Start Date: 07-01-2016 * End Date: 06-30-2017 Budget Period: 3

F. Other Direct Costs Funds Requested ($)

1. Materials and Supplies

2. Publication Costs

3. Consultant Services

4. ADP/Computer Services

5. Subawards/Consortium/Contractual Costs

6. Equipment or Facility Rental/User Fees

7. Alterations and Renovations

Total Other Direct Costs

G. Direct Costs Funds Requested ($)

Total Direct Costs (A thru F)

H. Indirect Costs

Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) * Funds Requested ($)

1. Total Direct Cost

Total Indirect Costs

Cognizant Federal Agency

(Agency Name, POC Name, and POC Phone Number)

I. Total Direct and Indirect Costs Funds Requested ($)

Total Direct and Indirect Institutional Costs (G + H)

J. Fee Funds Requested ($)

K. * Budget Justification File Name: Mime Type: application/pdf

(Only attach one file.)

RESEARCH & RELATED Budget {F-K} (Funds Requested)

Tracking Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 3 Page 95

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RESEARCH & RELATED BUDGET - Cumulative Budget

Totals ($)

Section A, Senior/Key Person

Section B, Other Personnel

Total Number Other Personnel 9

Total Salary, Wages and Fringe Benefits (A+B)

Section C, Equipment

Section D, Travel

1. Domestic

2. Foreign

Number: GRANT11483849 OMB Number: 4040-0001

Expiration Date: 04/30/2008

Subaward 3 Page 96

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
 HIV Incidence rapid test 

BUDGET JUSTIFICATION –

 (Scientific Director, P.I.), 35% effort 

Dr. as a inventor of a new technology and assay formats will provide 

overall scientific leadership (supervision) of project, coordination and guidance for 

the project He will write scientific reports for publications or presentations 

 (Senior Scientist) , 60% effort 

Dr. as a specialist in protein biochemistry will be responsible for 

synthesis of particles and polymers with hydrogen donors and peptides, development 

of strategy of stabilization of conjugates, components of substrate system, supervise 

stability study of the reagents, develop QC methods for reagents 

 (Scientist), 60% effort 

will be responsible for the development and optimization of diagnostic strips, integration 

plasma separation elements for whole blood testing, reagents stabilities studies, 

writing documentation 

 ( Associate Scientist ) 80% effort 

Will assist in development of reagents, stability study, 

optimization of components of diagnostic strips, analysis of various biological matrixes 

and materials for lateral flow tests 

Supplies 

Supplies to be purchased will include : various chemical reagents, cross-linking 

reagents, blocking reagents, stabilization products, biochemicals, materials for rapid 

test development (membranes, adsorbents, lamination films, cards, vacuum sealer 

bags, miscellaneous lab supplies ( plastic ware, tubes, filters, desiccants, etc.) 

Total three years cost: $ 

Equipment 

Equipment to be purchased will include benchtop freeze dryer with shelf system and 

stoppering (Virtis Advantage Plus Freeze Dryer XL, Cost ~$18,000), upgrade for 

spectrophotometer (Schimadzu UV1800 as a replacement of current UV1240, additional 

cost ~ $8,000) and rotary cutter for membranes (Bio-Dot, ~ $16,000) New freeze dryer 

need for manufacture of key reagents that require more precise control of drying 

conditions and stoppering under vacuum. Currently use freeze drier model do have 

this functions. Spectrophotometer is important equipment in reagent synthesis and 

analysis. New model should significantly reduce time for performing 

spectrophotometric data analysis in comparison with current UVmini1240, which do not 

have good data managing software. Rotary cutter will be used instead current 

Subaward 3 Budget Justification Attachment Page 97

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
guillotine-type cutter to attain more precise strip cutting with minimal contamination of 

the membrane edges with adhesive 

Total cost: $ 

Travel 

Total 3 Years Cost: $ 

Indirect Cost (F&A) 

F&A rate is 30%. 

Total for three years : $ 

Subaward 3 Budget Justification Attachment Page 98

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
SBIR/STTR Information OMB Number: 4040-0001 

Expiration Date: 6/30/2016

* Program Type (select only one)

* SBIR/STTR Type (select only one)

* 1a. Do you certify that at the time of award your organization will meet the eligibility criteria for a small business as defined in the funding 

opportunity announcement?

* 2. Does this application include subcontracts with Federal laboratories or any other Federal Government agencies?

* If yes, insert the names of the Federal laboratories/agencies:

* 3. Are you located in a HUBZone? To find out if your business is in a HUBZone, use the mapping utility provided by the Small Business 

* 4. Will all research and development on the project be performed in its entirety in the United States?

* Explanation:

* 5. Has the applicant and/or Program Director/Principal Investigator submitted proposals for essentially equivalent work under other 

Federal program solicitations or received other Federal awards for essentially equivalent work? 

* If yes, insert the names of the other Federal agencies:

* 6. Disclosure Permission Statement: If this application does not result in an award, is the Government permitted to disclose the title of 

your proposed project, and the name, address, telephone number and e-mail address of the official signing for the applicant organization, 

to organizations that may be interested in contacting you for further information (e.g., possible collaborations, investment)?

* 7. Commercialization Plan: If you are submitting a Phase II or Phase I/Phase II Fast-Track Application, include a 

Commercialization Plan in accordance with the agency announcement and/or agency-specific instructions.

* Attach File:

Questions 1-7 must be completed by all SBIR and STTR Applicants:

If no, provide an explanation in an attached file.

Administration at its web site: http://www.sba.gov 

SBIR STTR

Both (See agency-specific instructions to determine whether a particular agency allows a single submission for both SBIR and STTR)

Phase I Phase II

Fast-Track (See agency-specific instructions to determine whether a particular agency participates in Fast-Track)

Yes

No

35

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

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* 1b. Anticipated Number of personnel to be employed at your organization at the time of award.

	


 		

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SBIR/STTR Information Page 99

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
* 8. Have you received SBIR Phase II awards from the Federal Government? If yes, provide a company commercialization history in 

accordance with agency-specific instructions using this attachment. 

* Attach File:

* 9. Will the Project Director/Principal Investigator have his/her primary employment with the small business at the time of award?

* 10. Please indicate whether the answer to BOTH of the following questions is TRUE:

(1) Does the Project Director/Principal Investigator have a formal appointment or commitment either with the small business directly 

(as an employee or a contractor) OR as an employee of the Research Institution, which in turn has made a commitment to the 

small business through the STTR application process; AND 

(2) Will the Project Director/Principal Investigator devote at least 10% effort to the proposed project?

* 11. In the joint research and development proposed in this project, does the small business perform at least 40% of the work and the research 

institution named in the application perform at least 30% of the work?

SBIR-Specific Questions:

STTR-Specific Questions:

SBIR/STTR Information

Questions 8 and 9 apply only to SBIR applications. If you are submitting ONLY an STTR application, leave questions 8 and 9 blank and proceed to 

question 10.

Questions 10 and 11 apply only to STTR applications. If you are submitting ONLY an SBIR application, leave questions 10 and 11 blank.

Add Attachment Delete Attachment View Attachment

Yes

No

Yes

No

Yes

No

Yes

No

	


 		

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SBIR/STTR Information Page 100

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
RAPID HIV INCIDENCE TEST COMMERCIALIZATION PLAN

Value of the SBIR Project, Expected Outcomes, and Impact

Overview.

Assessment of the state of the HIV epidemic for epidemiologic purposes and targeting intervention efforts to 

populations exhibiting high rates of HIV transmission are wholly dependent on determining the frequency of 

new infections. However, very few HIV assays have been developed specifically to distinguish incidence from 

prevalence. Most HIV serologic assays are aimed at diagnostic use, while RNA assays have been used 

largely to determine viral load for clinical management purposes. The general lack of tools for this purpose 

reflects the greater focus on diagnostic applications by assay developers. We aim to serve a major public 

health need through the development of a new test capable of rapidly identifying new HIV infections.

Secondly, determining the frequency of new HIV infections has required access to well-equipped centralized 

laboratories capable of running the few sophisticated assays available for this purpose; these have been 

ELISAs requiring microplate handling and reading instrumentation, including the BED ELISA and the 

Vironostika detuned ELISA. Dependence on a central laboratory also implies the requirement for a system to 

. Immune 

complexes comprising antibodies and peroxidase conjugates migrate through membrane pores in lateral flow 

tests without formation of aggregation/agglutination migratory artifacts which are known to be a problem in 

lateral flow tests using large detector conjugates. 

Antibody detection format. The proprietary QuickELISATM format is based on using peptide conjugates for 

capture and labeling of specific antibodies without participation of secondary antibody conjugate binding 

reagents. This format allows for testing of antibodies in undiluted samples and detects all classes of antigenspecific antibodies. The higher sensitivity and specificity of this technology have been demonstrated by 

Immunetics in several past products including the FDA-approved Anthrax PA QuickELISATM test and a Lyme 

ELISA test marketed in Europe. 

Novel peptide antigens for improved sensitivity. The IDR-M antigen recently developed by Dr. Parekh at 

CDC overcomes the shortcomings of previous antigens (e.g. the BED antigen) in detection of multiple HIV 

subtypes, an essential requirement for a worldwide assay. We have transformed IDR-M into its constituent 

peptides for enhanced performance in the HIV rapid incidence test, allowing us to take full advantage of the 

QuickELISA methodology (above) in a rapid assay format.

Commercialization Plan Page 101

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Expected outcomes. 

At the conclusion of the proposed Phase II effort, we will have completed optimization of an HIV rapid test 

capable of discriminating incidence from prevalence in serum or plasma within a 15 minute turnaround time. 

Working together with , a highly experienced manufacturing partner for rapid 

tests, we will have configured, optimized and produced the HIV incidence rapid test in cassette format. Based 

on initial test performance data and on input from our collaborators at , we will design 

and perform multi-site field studies designed to determine the test sensitivity, specificity and false recency rate

with both well-characterized incidence/prevalence panels and prospective samples, and will evaluate the 

reproducibility, stability and impact of potentially interfering substances on test performance. These data will be 

submitted to FDA to support a waiver for non-diagnostic surveillance use of the assay, to our European notified 

body (Obelis SA) to support commercial introduction in Europe, and to regional regulatory agencies in other 

countries (e.g., in Africa, Asia and elsewhere ex-U.S.) as needed. With appropriate regulatory approvals or 

waivers, we expect to launch the rapid incidence test commercially in the U.S. and worldwide by the end of 

Phase II.

Impact. 

The availability of the first rapid test for HIV incidence will transform the field by putting a powerful tool for 

monitoring the HIV epidemic at the disposal of organizations and individuals operating primarily in the field, 

without the need for support services from a highly sophisticated central laboratory as currently required. 

Pending the results of field studies and the scope of the claims, this rapid test could ultimately lead to a change 

in the testing algorithm for HIV incidence by eliminating the need for RITA’s (Recent Infection Testing 

Algorithms) dependent on multiple tests to overcome the shortcomings of each individual test. Finally, 

commercialization of the HIV incidence rapid test will enable Immunetics to enter the growing rapid test market 

and demonstrate the utility of a novel detection technology with the potential to improve the standard of 

performance for HIV and rapid tests in general.

Company. 

Immunetics is a small business, currently with a staff of approximately full-time employees, focused on 

infectious disease diagnosis and pathogen detection. The company, started by Andrew Levin in 1987, has 

developed and commercialized a range of diagnostic assay products. Since inception, the Company has been 

funded by revenues from product sales, private (angel) investments, NIH grants and NIH contracts. About 

million in equity investment has been raised over the past 10 years. Total revenues exceeded million in 

2012, about 20% growth over 2011. The Company has been profitable since 2005 and is not dependent on 

equity investments to maintain and grow the business. Current staff include administrative/finance people, 

in marketing/sales, in Manufacturing and Quality Assurance, and in Product Development. In 2004, the 

Company moved from Cambridge, MA to its present location in Boston, where it occupies about 18,000 square 

feet of newly built-out office and laboratory space. It is currently expanding its laboratory with another 9,000 sf 

to accommodate growth needs. The facility has passed four successive FDA inspections with no findings and 

operates with GMP infrastructure ensured by a Quality Assurance director supported by an external regulatory 

consultant. In 2009, the Company achieved ISO13485 certification, a mark of excellence requiring adherence 

to the highest quality standards throughout all company operations. Pertinent to this application, Immunetics 

has recently recruited as CEO John Yonkin, the former President of Alere, Inc., a global firm specializing in 

development and marketing of point-of-care tests for physician and consumer use. Mr. Yonkin brings extensive

and directly relevant industry experience to the launch of this novel point-of-care test. Immunetics’ Vice 

President, Richard Pinkowitz, was likewise a marketing and sales executive at Alere’s predecessor Inverness 

Medical, where he managed the sales of point-of-care tests for diabetes and brings significant marketing and 

sales experience to the company. Dr. Andrew Levin, Immunetics’ President and Scientific Director, has over 20 

years of experience in the development of HIV assays, most recently as Principal Investigator of a $10 million 

contract from the National Heart, Lung and Blood Institute for development of the HIV Selectest, an ELISA for 

discrimination of HIV infection from vaccine-induced antibody responses. 

Development of the rapid test will be guided by , Dr. Victor Kovalenko. He is the 

inventor of the antibody detection technology (QuickELISA) and colorimetric detection system for rapid 

diagnostic tests and has extensive experience in diagnostic reagents and assay development in various 

formats, gained at Immunetics and prior academic and industrial positions. Both Immunetics’ FDA-approved 

C6 Lyme IgG/IgM ELISA and Anthrax Protective Antigen ELISA kits were developed under his supervision. He 

is also a principal at Diagnostic Innovations, Immunetics’ consortium partner in several joint projects for rapid 

diagnostic test development. 

Commercialization Plan Page 102

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Blot assay devices. The Miniblotter® instrument, a device developed and patented by Dr. Levin for incubation 

and processing of multiple samples on western blot and other membranes, was the Company’s first product. 

The Miniblotter® product line continues to be a source of revenue for the Company, with over 5,000 users 

worldwide. These instruments have been used by Immunetics and its customers to develop many specialized 

assays for both research and clinical purposes, including miniaturized assays for HIV antibodies in neonatal 

dried blood spots, the checkerboard assay format for detection of multiple antibody-antigen pairs, and for 

multiple nucleic acid hybridizations, which has led to the development of tests now in widespread use for 

clinical evaluation of periodontal pathogens, the spoligotyping method, an epidemiological and diagnostic tool 

for analysis of Mycobacteria strains, and numerous others. Immunetics has also developed the CodaXcelTM 

instrument, a device which accelerates the processing time for western blots and nucleic acid hybridization 

blots, providing a start-to-finish time of approximately 15 minutes in place of hours.

Diagnostic assay products. Immunetics’ main diagnostic product line comprises a series of immunoassay 

kits for detection of antibodies as markers of infection. Diagnostic assays which were brought from inception to 

market include Western Blot assay kits for HIV-1/2 (under license from the U.S. government), Cysticercosis 

(under license from the U.S. government/Centers for Disease Control), Hydatid Disease, Lyme disease 

for HGE based on a recombinant antigen. These are the first and only products of their type brought to market. 

Grant AI45809 supported the development of a recombinant antigen-based rapid test for Lyme disease. Under 

this grant, Immunetics began work with VlsE, a newly discovered protein antigen of Borrelia burgdorferi. This 

work has led to the development of a new, highly sensitive and specific ELISA for Lyme disease based on the 

C6 peptide of VlsE, a patented technology now licensed exclusively to Immunetics. This represents the first 

peptide-based serodiagnostic test for Lyme disease, which has been shown by laboratories in the U.S. and 

European countries to offer the highest combination of sensitivity and specificity currently possible in a single 

assay. A series of published studies have documented the advantages of the C6 ELISA over other serologic 

tests. The Company has conducted clinical trials of the new Lyme ELISA, filed a submission to the FDA, and 

received 510(k) clearance in May, 2001. The C6 Lyme ELISA is now in use in major clinical laboratories in the 

U.S. and Europe, has arguably become the standard of performance in the field, and is the Company’s top 

source of sales revenue. Under grant AI51926, Immunetics evaluated the clinical performance of the C6 ELISA 

with and without an additional peptide component (C10 from the OspC protein) proposed to enhance 

sensitivity. This grant supported initial clinical studies comparing the C6 ELISA to the widely accepted 

ELISA+Western Blot protocol recommended by CDC in 1994. The Company extended these studies in a 

multicenter clinical trial, carried out in 2005-2006, which was the largest and most stringent ever conducted for 

Commercialization Plan Page 103

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
a Lyme disease diagnostic test – involving approximately 500 well-characterized retrospective clinical samples, 

1,200 prospective patient samples and over 2,000 controls (published recently in Diagnostic Microbiology and 

Infectious Diseases (2013) 75(1):9-15). Immunetics has submitted a 510(k) application to the FDA based on 

the trial data, supporting the claim that the C6 ELISA can be used as a single-step test for Lyme disease, with 

no confirmatory Western Blot needed – a precedent of significance for the diagnosis of Lyme disease, with 

ramifications for the Company’s market position with this product. Through this clinical trial, Immunetics has 

acquired experience in the design and management of a multicenter clinical trial, data management, regulatory 

aspects, FDA interaction, HIPAA compliance, Quality Assurance requirements and infrastructure, business and 

administrative organization, and financial requirements.

With support from NIAID Phase I SBIR grant R43 AI091291, Immunetics has developed a rapid test for Lyme 

disease. The prototype rapid test employs the proven C6 antigen used in the FDA-approved Lyme C6 ELISA 

test together with a second peptide, C10, that increase sensitivity for antibody detection at earliest stages of 

disease. The rapid test utilizes Immunetics’ proprietary QuickELISA assay technology, which exhibits high 

sensitivity and specificity. Detection of reactive samples will employ a proprietary detection system, which uses 

enzyme catalysis and a novel stable multicolor substrate system (Patent application 61/494,232, filed 

has completed clinical trials of the BacTxTM kit, and received FDA (CBER) 510(k) approval in June 2012 for 

testing of whole blood-derived platelets and in August 2013 for testing of apheresis platelets. This experience 

with a regulatory approval for a blood test through CBER will be relevant to other blood screening tests under 

development for Chagas disease, babesiosis and HIV. We consider this a major strength supporting our 

capability to carry out the proposed project successfully from start to finish.

Chagas disease test. With support from NIAID grant R44 AI080021, Immunetics is developing an 

immunoblot-based serological confirmatory test for Chagas’ disease, a chronic infection with the parasite 

Trypanosoma cruzi, which has emerged recently as a significant new threat to transfusion safety in the U.S. 

and elsewhere. As a result of the large number of immigrants from Latin America into the United States and 

other countries, up to several hundred thousand individuals in the U.S. are currently believed to be infected 

with T. cruzi. T. cruzi serology is limited in accuracy, though, by a high level of cross reactivity with Leishmania, 

as well as other microbial pathogens and disease conditions. To address this concern, the confirmatory test 

under development will include both native Chagas protein fractions and Leishmania antigen peptides. The 

goal of the project is to complete development of the test and to generate validation data in preparation for 

clinical trials. We will seek to receive clearance of the test from CBER for use in confirmatory blood screening 

as well as from CDRH for use in patient diagnosis.

Commercialization Plan Page 104

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
HIV Selectest - discriminatory test for infection vs. vaccine-induced seropositivity. The vaccine trial market is 

the target for a project at Immunetics supported by a recently awarded major contract from the NHLBI under its 

REDS-II (Retrovirus Epidemiology Donor Study) project. Under this contract, Immunetics is developing an 

ELISA aimed at distinguishing between the immune response to HIV infection and to experimental HIV vaccine 

antigens. Currently, individuals participating in clinical trials of HIV vaccines test positive on standard HIV 

screening assays based on cross-reaction between vaccine and native virus antigens. The new test under 

development is based on recently identified peptide antigens which react with sera from infected individuals but 

not from HIV vaccine recipients. When development is completed, this ELISA will be evaluated in a large-scale 

clinical trial and an application will be submitted to the FDA for approval for vaccine trial use. The test kit will 

then be made available for use in government and industry-sponsored HIV vaccine trials. Through this project, 

Immunetics is gaining experience in the regulatory and QA compliance requirements for development, 

manufacture and release of a blood screening test, and likewise in the regulatory approval pathway defined by 

the Center for Biologics Evaluation and Research (CBER) at the FDA. Experience gained with the CBER 

requirements and regulatory pathway will be directly translatable to other blood screening tests under 

development, including tests under development for Chagas disease and babesiosis.

underscores the potential value of molecular detection methods. A further extension of the reverse line blot 

system in another direction is underway supported by NIAID grant AI080004, in which primers and probes are 

being developed to permit detection and identification of trypanosomal diseases, in particular African 

trypanosomiasis caused by T. brucei subspecies, and to differentiate between these and other pathogenic and 

non-pathogenic kinetoplastids.

Immunetics staffing and financial base. 

As a small but growing business, Immunetics faces the same challenges that many other small technologybased companies face. Recruiting talented people for creative and managerial positions is a key requirement 

for success. Based in Boston, Immunetics presents an attractive opportunity in a location well-known for its 

large biomedical community. We consider that our success in recruitment is due in large part to the pipeline of 

products, most of which have been developed with support from NIH grants. Since 2005, the company has 

been operating at a profit, based on increasing sales of its core products (above). With management capable 

of delivering both profitable operations and growth in revenues at about 15%-20% per year based on current 

products (last 2 years), the Company is well-positioned to expand its business. Equity financing will be sought

based on market conditions, but the Company is not dependent on it for operations and growth. Over the next 

5 years, Immunetics envisions accelerating growth in all aspects, including sales revenue from the launch of 

Commercialization Plan Page 105

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
the BacTx® kit and other products, the new product development pipeline, manufacturing capability, and sales 

and marketing impact. The Company’s long term objective is to return value to its shareholders, which may be 

achieved by an eventual merger or acquisition, public offering, or management buyout.

Market, Customer and Competition

Market size and share. An estimated 60,000-100,000 HIV incidence tests for population studies are currently 

performed annually worldwide (Scenario 1, below). This figure is based on a 2009 study funded by the Bill and 

Melinda Gates Foundation [7]. HIV incidence testing is thus an “orphan” market, yet one which plays an 

essential role in public health efforts to contain the epidemic and interdict HIV transmission. The study cited 

three scenarios with different market size estimates. Because the scenarios are relevant to our plans for 

intended use of the HIVI rapid test, we have quoted them directly here:

(1) Scenario 1: The current situation, in which HIV incidence assays are used only on HIV-seropositive 

specimens and demand is influenced by suboptimal performance.

(2) Scenario 2: An improved HIV incidence assay is widely available at a low cost and performs consistently 

well across HIV-1 subtypes. This new assay is used only on HIV-seropositive specimens.

(3) Scenario 3: A novel HIV incidence assay is developed that can be used both to determine HIVseropositivity and to identify how recently a given sample was infected. This assay would be used for public 

health and research purposes, rather than individual patient diagnosis.

 

 of approaches to incidence testing in past years have relied on modifications of existing diagnostic 

tests – typically by detuning assay sensitivity, practiced on the Vironostika EIA, Vitros EIA, Architect and 

Axsym EIA, Inno-LIA and several others [7]. However, none of these assays have adequately satisfied desired 

performance criteria including low false recency (FRR) rates [5,10]. The CDC LAg ELISA based on rIDR-M, 

now offered commercially by Sedia and Calypte, represents the only assay which appears to come close to 

meeting desired FRR and other criteria. Currently there are no direct competitors with an HIV incidence rapid

test on the market, although some efforts are being made to modify conventional rapid HIV screening tests for 

incidence use, such as the Uni-Gold Recombigen test [7]. These modified assays will almost by definition 

have fairly complex test protocols, and in some cases a RITA (recent infection testing algorithm) is anticipated. 

In a RITA scenario, multiple assays or a combination of test results and clinical information are used to 

establish and/or confirm recency [5], adding to the overall complexity and cost of determining HIV incidence by 

Commercialization Plan Page 106

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
population surveillance. Based on our data to this point, we believe we can produce, validate and 

commercialize a single, simple, accurate, HIVI rapid test with a false recency rate equivalent to the LAg ELISA, 

eliminating the need for a complex and costly RITA. Thus we expect to gain market share rapidly, and project 

capturing TAM share (as above) within 3 years of product launch.

 

 

 

 

 

 

 

Commercialization Plan Page 107

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Intellectual property protection

The HIV incidence rapid test employs a proprietary antibody capture and detection method, covered by U.S. 

patents 7,262,019, 7,125,517, and 7,105,311 issued to Immunetics. This method, termed QuickELISATM, 

allows capture of labeled antibodies in one step, and has been used by Immunetics in commercially available 

and FDA-approved serological tests for Lyme disease and Anthrax.

The IDR-M peptide used in the HIV rapid test is in the public domain and not covered by an issued patent 

based on the publication of its sequence and properties in 2010 [13]. CDC has acknowledged that no patent 

has been filed on IDR-M. Our patent attorneys are available to resolve any freedom-to-operate issues which 

may arise, whether merited or not.

The rapid test also employs a new highly-sensitive, multi-color detection system (U.S. Patent application 

61/494,232 filed by Immunetics June 7, 2011). Immunetics has also reviewed the intellectual property 

landscape for lateral flow rapid tests in general, and has concluded that we will have freedom to operate based 

on the intended test design and on the impending expiration of several patents covering lateral flow 

technology.

Finance plan

Final rapid test kit manufacturing. 

Final production steps for the HIV incidence rapid test kits will be performed at Immunetics, including 

manufacturing and dispensing of wash buffer and kit controls, product labeling, and assembly of components 

into kits comprising 10 tests. Immunetics has the facilities and capacity to perform such kit production and 

packaging tasks within our FDA registered manufacturing facility located in Boston, as we currently do for the 

FDA-cleared BacTx®, Anthrax and C6 Lyme ELISA kits. Following manufacture and QC, HIV incidence rapid 

test kits will be sequestered in a cold room as inventory ready to ship. Space will be set aside to accommodate 

sufficient kits to maintain a rolling inventory adequate to cover anticipated shipments within the next 90 days. 

For this purpose, a 400 sf cold room and separate 200 sf cold room are available. Immunetics has adequate 

unused space to install additional cold storage if needed to maintain larger inventory levels. Should production 

requirements rise beyond Immunetics’ and DCN’s capacity, we will contract production to a higher volume 

manufacturer of rapid tests, of which a variety of companies are known in the U.S. and Asia which are FDAcertified and meet high quality assurance standards.

Commercialization Plan Page 108

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Marketing plan and sales strategy.

Product positioning and regulatory position. 

Previous HIV incidence ELISA assays have been positioned for regulatory purposes as population surveillance 

 

Sales strategy. 

Revenue stream

Commercialization Plan Page 109

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
COMMERCIALIZATION HISTORY 

Current: 

Contract No. (Phase II) 

Title: Screening and Confirmatory Tests for Human Babesia 

Agency: National Heart, Lung and Blood Institute/National Institutes of Health 

Performance Period: 08/31/2-12 – 08/30/2014 

Total award: $3,667,660 

Commercialization status: 

The Babesia ELISA test is currently in IND clinical trials leading to an FDA submission for BLA licensure. 

Summary: 

The aim is development and regulatory approval of an immunoassay for Babesia seropositivity, to be used as 

a high throughput blood screening test to prevent transfusion-transmitted babesiosis. The test employs unique 

immunodominant antigens specific for B. microti. 

Phase III and other funding: 

Follow-on funding from the Company’s current product revenue sources will be used to support initial 

manufacture and release of product following FDA licensure. Funding has also been received from BSRI, our 

partner in clinical trials and in commercialization of the product. 

Grant No. (Phase II) 

Title: Confirmatory Immunoblot Test for Chagas’ Disease 

Agency: National Institute of Allergy and Infectious Diseases/National Institutes of Health 

Performance Period: 06/01/08 – 02/28/14 

Total award: $2,410,129 

Commercialization Status: 

Product in development, planned for clinical trials in 2013-2014 followed by FDA submission and commercial 

launch upon FDA clearance. 

Summary: Development of an immunoblot assay for antibodies to T. cruzi, the agent of Chagas’ disease, for 

use as a confirmatory test in clinical diagnosis and blood screening. The immunoblot assay will be significantly 

easier to use than radioimmunoprecipitation (RIPA), the current standard, which is only practiced in a handful 

of laboratories nationwide. Chagas’ has been identified as a threat to the blood supply and a confirmatory test 

is required for blood screening. The disease affects over 25 million people worldwide, principally in Latin 

America, and confirmatory testing for clinical diagnosis is likewise a critical need. 

Previous: 

Grant No. (Phase II) 

Title: Rapid Assay for Bacterial Contamination of Platelets 

Agency: National Heart, Lung and Blood Institute/National Institutes of Health 

Performance Period: 10/01/02 – 8/31/10 

Total award: $ (through 8/31/07) 

Phase III Funding: 

Follow-on funding from the Company’s current product revenue sources plus an investment round in 2006 

yielding about $ Additional product revenues projected from sale of product following FDA approval. 

Prior SBIR Phase II Awards Page 110

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Commercialization status: 

FDA 510(k) clearance for the BacTx® rapid test for bacterial detection in whole blood-derived platelets obtained 

in June 2012. FDA 510(k) clearance for use on apheresis platelets received in August 2013. Product launch 

planned for Q4 2013. This is only the second product cleared by the FDA for this application. 

 

Summary: Development of an assay based on peptidoglycan-binding proteins for the detection of bacteria in 

platelet units. This assay addresses an acute need in the blood bank and transfusion unit, where bacterial 

contamination of platelets causes both morbidity and mortality. The peptidoglycan-binding assay offers high 

sensitivity and specificity in a rapid, simple and inexpensive format for blood bank or point-of-care use. 

Grant No. (Phase II) 

Title: Rapid Confirmatory Lyme Disease Test 

Agency: National Institute of Allergy and Infectious Diseases/ National Institutes of Health 

Performance Period: 9/15/97 – 2/29/00 

Total award: $ 

Phase III Funding: 

Investment rounds led by Stonegate Partners during this period raised about $5 million, which in part 

supported commercialization of the C6 Lyme ELISA developed under this grant. 

Commercialization status: 

In Phase III, the C6 peptide Lyme ELISA was validated, received FDA 510(k) approval, was patented, and has 

been launched commercially by Immunetics. It is now the Company’s lead product by revenue, showing about 

20% growth in sales per year. It is in routine use in major clinical laboratories in the U.S. and Europe. 

Summary: The aim was development of a rapid immunoassay for Lyme serodiagnosis. Immunetics evaluated 

a wide range of recombinant Lyme antigens, focused on antigens with high sensitivity and specificity. Antigens 

were evaluated on serum panels including Lyme-positive, normal and potentially cross-reactive sera. The VlsE 

antigen was selected, and the C6 peptide sequence within VlsE ultimately chosen for use in the final ELISA 

version. 

Grant No. (Phase II) 

Title: Tick-Borne Disease Panel Test 

Agency: National Institute of Allergy and Infectious Diseases/ National Institutes of Health 

Performance Period: 8/31/99 – 2/28/02 

Total award: $ 

Phase III Funding: 

Two investment rounds led by the Company’s Board of Directors during this period raised about $1 million, 

which in part supported commercialization of the Babesia and Ehrlichia tests developed under this grant. 

Commercialization status: 

Immunetics was awarded U.S. patent #6,013,460 for a modified Western Blot for detection of multiple tickborne diseases. The Babesia Western Blot was validated in a study published in Clinical and Diagnostic 

Laboratory Immunology (2001) 8(6):1177-1180. The Babesia Western Blot kit and HGE ELISA and Western 

Blot kit were produced and marketed as the first commercial kits of their type for serodiagnosis of these 

diseases. 

Summary: This project was aimed at development of a panel of tests for tick-borne pathogens including Lyme, 

Human Granulocytic Ehrlichiosis, and Human Babesiosis. Immunetics evaluated Lyme, HGE and Babesia 

native and recombinant antigens in ELISA, dot blot and Western Blot formats. Development resulted in the 

first ELISA and Western Blot assays for HGE and Babesia based on semi-purified native antigen lysates. 

Prior SBIR Phase II Awards Page 111

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
PHS 398 Cover Page Supplement

1. Project Director / Principal Investigator (PD/PI)

* Title:

* Street1:

* City:

* Country:

Street2:

County/Parish:

* State:

* Zip / Postal Code:

Prefix: * First Name:

Middle Name:

* Last Name:

Suffix:

2. Human Subjects

Clinical Trial?

* Agency-Defined Phase III Clinical Trial?

* First Name:

Middle Name:

* Last Name:

Suffix:

3. Applicant Organization Contact

Person to be contacted on matters involving this application

* Phone Number: Fax Number:

Email:

OMB Number: 0925-0001 

Province:

Prefix:

Dr. Patricia

Garrett

No Yes

No Yes

	


 		

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Clinical Trial & HESC Page 112

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
4. Human Embryonic Stem Cells

* Does the proposed project involve human embryonic stem cells?

If the proposed project involves human embryonic stem cells, list below the registration number of the 

specific cell line(s) from the following list: http://stemcells.nih.gov/research/registry/. Or, if a specific 

stem cell line cannot be referenced at this time, please check the box indicating that one from the 

registry will be used: 

Specific stem cell line cannot be referenced at this time. One from the registry will be used.

PHS 398 Cover Page Supplement

No Yes

Cell Line(s):

	


 		

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Clinical Trial & HESC Page 113

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
PHS 398 Research Plan

1. Application Type:

From SF 424 (R&R) Cover Page. The response provided on that page, regarding the type of application being submitted, is repeated for your 

reference, as you attach the appropriate sections of the Research Plan.

*Type of Application:

OMB Number: 0925-0001 

2. Specific Aims

3. *Research Strategy

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

8. Targeted/Planned Enrollment Table

9. Inclusion of Children

10. Vertebrate Animals

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

1. Introduction to Application 

(for RESUBMISSION or REVISION only)

Human Subjects Sections

2. Research Plan Attachments: 

 Please attach applicable sections of the research plan, below.

Other Research Plan Sections

5. Progress Report Publication List

11. Select Agent Research

12. Multiple PD/PI Leadership Plan

4. Inclusion Enrollment Report

New Resubmission Renewal Continuation Revision

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List of Research Plan Attachments Page 114

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Specific Aims 

Accurate estimates of HIV incidence (the rate of new HIV infections) are critical for policy decisions, for 

monitoring the epidemic, and for planning and evaluating interventions. Despite more than a decade of effort, 

significant barriers to progress remain [5,10]. Two such barriers have been the lack of an incidence assay for 

field work and resource-poor settings, and the unavailability of serially collected plasma panels for assay 

evaluation from individuals with closely estimated infection dates. In this project, we propose to transform HIV 

serological incidence testing from ELISA methodology based on avidity and titer and requiring a laboratory with 

sophisticated infrastructure, to a field procedure using a simple, stable, and reliable rapid test. In Phase I, we 

have developed prototypes of a new, highly sensitive rapid test based on novel colorimetric detection 

technology, which allows the analysis of antibody titer and avidity in less than 15 minutes within a single 

cassette. The rapid assay is based on synthetic peptides derived from a recently developed multisubtype gp41 

HIV peptide antigen (IDR-M) which is the basis for the currently state-of-the-art limiting antigen (LAg) ELISA for 

incidence testing [13,15,16]. Evaluated with a CDC panel of 188 samples (57 recent, 131 long-term), the new 

rapid assay with one synthetic peptide yielded > 98% correlation with the LAg ELISA (Table 2, Research Plan). 

In Phase II, we will evaluate the accuracy of the new rapid test for classification of recent vs. long-term HIV 

infections using well-characterized serum/plasma panels developed specifically for this purpose. These will 

include a panel representing recently HIV-infected individuals (HIV RNA positive/anti-HIV negative at 

recruitment) collected over a two year period as a specific aim in Phase I. Field evaluations of the rapid test 

will be carried out in collaboration with public health agencies. In Phase II, we plan to optimize, validate and 

commercialize the HIV incidence rapid assay with the following specific aims: 

Aim 1. Complete development of an optimized HIV incidence rapid test based on the rIDR-M antigen or 

synthetic peptides derived from it. 

a. Optimization of antibody capture format, colorimetric detection system, dissociation conditions, interpretation 

criteria, test strip format and housing to yield <2% false recency compared to LAg ELISA; 

b. Preparation and validation of plasma controls (incident, prevalent, negative) using dried tube specimens [2] 

or lyophilization. Validation will involve comparison with standard controls’ ability to detect introduced error. 

Correlation of >95% will signal success. 

c. Simultaneous preparation of instructions for use, interpretation spreadsheet and training package, including 

photographs or video of test method process and interpretation; 

d. Design of cassette, transfer to manufacturing and manufacture of pilot lots of the rapid test for laboratory 

and field evaluations. 

e. Field testing of device and peripherals for accuracy, ease of use, reproducibility, and clarity of interpretation; 

data review and analysis; modifications as required. Four resource-limited sites from among CDC sites in 

Malawi, Botswana and Kenya and MHRP sites in Nigeria, Tanzania, and Thailand will test 200 sequential 

unlinked samples each in parallel with LAg ELISA or their current population surveillance method. The goal 

will be >98% correlation. Discrepants will be investigated to the extent possible, and appropriate modifications 

made to the assay. 

Aim 2. Validate the final-format HIV incidence rapid test performance using plasma panels with closely 

estimated HIV infection dates and other relevant sample sets from DOD, CDC, CEPHIA, Blood Systems 

Research Institute and SeraCare. 

a. Analysis of sensitivity and specificity of antibody detection and discrimination of recent vs. long-term 

infections across multiple subtypes with seroconversion series and other repository samples from known longterm infections, elite controllers, and ART-treated and non-treated individuals with a goal of ≤ 2% false 

recency; 

b. Evaluation of a rapid plasma separation device [17] to allow population surveillance with whole blood 

samples when necessary: comparison of fresh plasma samples (incident and prevalent) from spun whole 

blood and membrane-separated whole blood will be performed at Blood Systems Research Institute with a 

goal of >98% correlation between specimen types. 

Aim 3. Prepare data from all studies for publication and for submission to FDA for waiver of approval 

to allow intended use for population surveillance, for submission for CE mark, and for other regulatory 

approvals as appropriate. 

a. To make the HIVI rapid test commercially available, we will pursue regulatory waiver from the FDA and 

approvals in target countries/regions, including Africa and Asia. 

Specific Aims Page 115

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
SIGNIFICANCE

Over three decades into the global HIV epidemic, identifying new HIV infections is critical to the evaluation of 

prevention and intervention strategies, because these must be specifically directed at interdicting new 

infections. The cost of HIV prevention programs exceeds $10 billion/year worldwide, while UNAIDS estimates 

about 2.5 million new infections annually, such that each new infection is worth about $4,000 in prevention 

efforts [15]. As such, improvements in targeting prevention efforts more specifically to populations with high 

rates of new infection should lead to greater cost-effectiveness and greater success in reducing HIV 

transmission. A significant challenge has been to identify new infections, however. 

Very few HIV assays have been developed specifically to distinguish new from established HIV infections, i.e. 

to distinguish incidence from prevalence. Most HIV serologic assays are aimed at diagnostic use, while RNA 

assays have been used largely to determine viral load for clinical management purposes. Acute HIV infection 

can be detected by tests such as p24 antigen capture, but the time frame for such acute infection is limited to 

about 3 weeks post-infection, while a “recent” infection for purposes of determining incidence is typically 

defined as within one year. Assessment of the state of the HIV epidemic for epidemiologic purposes is wholly 

dependent on determining the frequency of new infections. The general lack of tools for this purpose reflects 

the greater focus on diagnostic applications by assay developers due to the perceived larger market for 

traditional clinical diagnostics. A first generation of incidence assays have been developed, such as the wellknown BED ELISA and Vironostika detuned ELISA, along with assays targeting specific immunodominant 

epitopes, p24 antigen detection and others, but their limitations have become increasingly obvious 

[5,10,15,16]. The World Health Organization (WHO) formally advised to discontinue use of the BED assay in 

2005 due to its low level of accuracy, and other assays have shown similar problems. Given the limitations in 

accuracy of single first generation incidence assays, dependence on RITA’s or Recent Infection Testing 

Algorithms combining results of more than one type of test is increasing. Recognizing this need, the WHO 

with support from the Bill & Melinda Gates Foundation appointed a Technical Working Group on HIV Incidence 

Assays in 2008 (http://www.who.int/diagnostics_laboratory/links/hiv_incidence_assay/en/index.html) to develop 

recommendations for assay development, validation and commercialization [5]. At a recent (2010) meeting on 

the state of HIV incidence assays, participants concluded that a “standard, accurate, inexpensive and easy to 

use commercial kit” is urgently needed to estimate HIV incidence [10]. We aim to serve a major public health 

need through the development of a new test capable of rapidly identifying new HIV infections. 

Secondly, determining the frequency of new HIV infections has required access to well-equipped centralized 

laboratories capable of running the few sophisticated assays available for this purpose; these have been 

ELISAs requiring microplate handling and reading instrumentation, including the BED ELISA and the 

Vironostika detuned ELISA [7]. Dependence on a central laboratory also implies the requirement for a system 

to transport serum specimens from where they have been collected to the laboratory, a separate and acute 

logistical challenge in low-resource settings where refrigeration may not be available or dependable. A rapid 

test capable of identifying new infections that could be administered in real time in the field, where the subject 

is located rather than in a laboratory, would offer major benefits. 

In Phase I, we have developed a prototype serological assay in a rapid (< 15 minute), point-of-care format for 

distinguishing recent from long-term HIV infection using antibody avidity, and we have generated an 

incidence/prevalence serum panel useful in characterizing such assays through serial collections from six 

recently HIV-infected individuals over almost two years. The simplicity of this rapid assay, in contrast with 

conventional laboratory-based assays, offers to make incidence testing available to all potential users, 

especially in low-resource settings. As has been demonstrated in other fields where the advent of point-ofcare tests has resulted in more timely and effective clinical management, the HIV incidence rapid test will 

provide a new and powerful tool for public health which may similarly lead to significant advances in the field. 

We propose in Phase II to complete development, validate and pursue appropriate regulatory approvals or 

waivers for this transformative HIV incidence (HIVI) rapid test, intended for population surveillance, that 

combines three innovative components: a capability to distinguish recent from long-standing infection that uses 

a unique one-step approach to determining antibody avidity; a novel multicolor colorimetric enzymatic detection 

chemistry with ELISA-equivalent sensitivity, and a synthetic peptide antigen combination with significantly 

improved detection equivalence for multiple group M HIV subtypes. The new rapid HIVI test will fill the acute 

need for an accurate incidence test that meets the needs of all stakeholders involved in public health 

prevention and monitoring efforts and clinical research, from central facilities and laboratories to the field. 

Research Strategy Page 116

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
INNOVATION 

This project will introduce a significant innovation in the field of HIV incidence measurement - the first rapid test 

for identification of recent HIV infections designed for field use rather than performance in a central, wellequipped laboratory. This development will reduce the dependence on well-established laboratory 

infrastructures for epidemiologic surveillance in limited-resource areas where the HIV epidemic is most 

prevalent, including regions in Africa and Asia. The ability to carry out testing of HIV incidence in the field will 

eliminate the need to transport serum specimens in a stable way to a frequently distant central laboratory, 

thereby simplifying logistics and reducing cost. The real-time turnaround of results will likewise enable faster 

response time for public health efforts aimed at identifying populations with high HIV incidence. These 

features in synergy will transform the paradigm for HIV incidence testing from the current centralized and slow 

laboratory-based system to a rapid, field-based, decentralized and locally empowered system. 

The Immunetics HIVI rapid test will be the first to offer a combination of sensitivity and specificity for 

determining HIV recency in a rapid (< 15 minute) format. The test will use a novel, highly sensitive and stable 

colorimetric detection technology based on peroxidase-catalyzed dye formation with oxidative coupling to 

membrane immobilized dye-formation reagents, which was developed by Principal Scientist Dr. Kovalenko. 

The new detection chemistry will open the door to development of other highly sensitive rapid tests with unique 

ability for multicolor targeting in multiplexed assays, ideally suited for visual reading or simple densitometry. 

The IDR-M antigen on which the test is based is a recent innovation developed by Dr. Parekh et al. at CDC, 

and has shown significant advantages in serological detection of the complete spectrum of HIV clades [13]. 

Recombinant IDR-M is a tandem sequence of three gp41-derived peptides with varying sequences to optimize 

immunoreactivity with all HIV clades. While IDR-M has been employed for incidence – prevalence 

discrimination in a limiting antigen (LAg) ELISA format which has arguably become the current standard for 

incidence testing [15,16], application to rapid tests is a new and relatively unexplored area. A recent study by 

Granade et al. [1] demonstrates the potential for IDR-M to be used in a lateral flow format, but no commercial 

rapid test has yet been developed. Hence the use of the new IDR-M antigen in our unique, proprietary rapid 

test format is a second significant innovation. 

With respect to the underlying assay technology, the new HIV incidence (HIVI) rapid test embodies three 

further, distinct innovations: 

1) HIVI will combine antibody titer and avidity analysis in a simple lateral flow format with the sensitivity and 

specificity of an ELISA and the speed and simplicity of a rapid, point-of-care test. 

2) The HIVI rapid test will use a new, simplified approach to discriminate between recent and long-term 

infection: a one-step avidity assay specially developed for rapid tests, based on preventing low affinity antibody 

binding by addition of a chemical reagent upon sample addition rather than subsequent dissociation of a 

preformed complex. This new approach to prevent binding of low affinity antibodies, combined with a 

proprietary antibody capture format using peptide conjugates without secondary detection reagents 

(“QuickELISATM”), makes it possible to run a rapid test with minimal sample dilution or even undiluted, 

compared to typical sample dilutions of 1:20-1:200 required for most ELISAs. 

3) The high sensitivity of the HIVI rapid test is based on an innovative, stable, multi-color colorimetric detection 

system using peroxidase that is applicable to a broad spectrum of diagnostic tests (U.S. Patent application 

61/494,232 filed by Immunetics June 7, 2011). For the HIVI test, this detection system is integrated into the 

most popular rapid test format, a lateral flow strip test, providing sensitivity that significantly exceeds 

conventional colloidal gold or colored latex labels. An example of multiplexed detection of antibodies to 

several different envelope-derived HIV peptides using 

different colors for each is shown in Figure 1. The 

small sizes of the horseradish peroxidase (HRP)-

labeled conjugate and the antibody capture 

conjugate eliminate many problems with 

agglutination and migration of labeled immune 

complexes through typical lateral flow membranes.

Antibody detection with peptide antigen conjugates (QuickELISATM). The assay format based on antibody 

capture as a complex with two independent peptide conjugates (Figure 2) eliminates the use of labeled 

secondary antibody conjugates and provides a significant increase in specificity, capture of all antibody classes 

and ability for antibody analysis without sample dilution, which is critical to the simplicity of a rapid test protocol 

Figure 1. HIV positive sera. Sample dilution 1:40. 15 min test, 

multiplexed with 4 HIV peptide antigens including IDR-M1. 

Research Strategy Page 117

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
and increases 

analytical sensitivity. 

This method, termed 

“QuickELISATM”, was 

developed by 

Principal Scientist Dr. 

Kovalenko and is 

covered under U.S. 

patents 7,105,311 

and 7,125,517. In a 

QuickELISA assay, 

one molecule of 

peptide antigen is conjugated with detector label, while the second is conjugated to a component of a highaffinity binding pair (streptavidin). The second component of this high affinity binding pair (e.g. biotinylated 

protein) is immobilized on the solid phase at high density. Unlike conventional tests with secondary conjugates, 

where samples must be diluted typically 20-200 fold before transfer to wells, the QuickELISATM test with 

peptide conjugates can be run with undiluted sera. Only the label involved in specific complex formation is 

captured and detected, making the test insensitive to most factors related to non-specific site reactions. The 

absence of a species- and isotype-specific secondary antibody enables detection of both IgG and IgM along 

with other multivalent antibody classes in a single assay. This approach has been used successfully by 

Immunetics in a commercial, FDA-cleared serological test for Anthrax Protective antigen and a Lyme C6 

QuickELISA test marketed in Europe. 

APPROACH 

Phase I Report. 

Rapid test detection technology. Our rapid test technology integrates a catalytic peroxidase detection 

system (Figure 3) with a new type of two-component stable substrate system, where one component 

(hydrogen donor) can be passively immobilized on membranes through use of a soluble polymer–coupled 

hydrogen donor conjugate or incorporated into membrane pores as particle-loaded reagents. The second 

component (coupler) is present in a free form, and is oxidized by peroxidase in the presence of a peroxide as 

primary peroxidase substrate. The oxidized coupler reacts with the membrane-immobilized hydrogen donor 

with formation of stable, light-insensitive contrast dyes. The availability of a plurality of hydrogen donor 

compounds opens unique possibilities for lateral flow tests where the internal control zone and several test 

zones produce different colors, simplifying visual analysis. The sensitivity of this detection system equals or 

exceeds the sensitivity of ELISAs with common HRP labeled reagents and the best colorimetric 

tetramethylbenzidine (TMB) HRP substrate. The new rapid test can detect antibodies at nanogram/ml 

concentrations and at dilutions up to 10 million-fold for some strongly positive samples. This substrate system 

also produces signals free from the diffusion frequently seen with precipitating peroxidase substrates. All major 

components of the new detection technology can be incorporated into lateral flow cassettes in a stable dry 

form (substrate reagents, capture/detector reagents), allowing long term storage at ambient temperature. 

Lateral flow tests with HRP as a label can be fabricated in a configuration requiring only one liquid component, 

an assay wash buffer, as in conventional lateral flow tests. The availability of efficient commercial 

immunoassay stabilizers and blockers, and experience with peroxidase stabilization, suggested to us that HRP 

or other thermostable peroxidases can be used as a label in rapid diagnostic tests with stability similar to 

conventional particle-based 

colorimetric labels. We have 

developed reagents which function 

efficiently as membrane 

blockers/stabilizers, conjugate 

drying buffers, and dry substrate 

reagents containing a coupler and 

a stabilized peroxide compound. 

Approach for simultaneous analysis of antibody titer and avidity. Analysis of antibody avidity is the best 

currently available approach for serological analysis of HIV incidence. Several ELISA-based methods have 

been developed and commercialized for avidity analysis, designed for discriminating recent from past or 

Figure 2. Antibody capture schemes for ELISA and membrane-based rapid tests.

Figure 3. Principle of peroxidase-based detection chemistry.

Research Strategy Page 118

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
chronic infection (e.g., for CMV, herpes, toxoplasmosis, and hepatitis, as well as HIV), all based on comparison 

of antibody binding to a solid phase immobilized antigen before and after incubation with reagents that 

dissociate low affinity antibodies (i.e., low pH, or chaotropic reagents such as urea, ammonium thiocyanate, 

guanidine). The dissociation reagent must be removed before treatment with secondary detection conjugate. 

The difference between signal before and after dissociation correlates with the proportion of low avidity 

antibodies. 

For the HIVI rapid test, we plan a simpler version of avidity detection, more suitable for a lateral flow device. To 

eliminate the additional dissociation and washing steps, we have changed the function of the dissociation 

reagent from dissociation to prevention. In our new HIVI method, the dissociation reagent is present when 

sample is incubated with antigen, and thus binding of low affinity antibodies is prevented. Combining this 

method with the use of two antigen conjugates in an antibody capture format (“QuickELISA” format described 

above) results in a one-step assay where prevention of low avidity antibody binding and labeling of bound 

antibodies proceed together in one incubation step. Following washing to remove non-bound label, the test is 

ready for detection of bound label (i.e., color development/substrate reaction). 

 

 

sensitivity of the signal to the dissociation reagent between recent and long term infection samples (i.e., 

incident vs. prevalent, as defined by LAg ELISA results) is shown on the score card in Figure 6. The score 

card illustrates expected band patterns obtained with a range of incidence and prevalence serum samples as a 

working reference standard. An internal positive control line (red) is included to qualify an assay as valid. Test 

results for an unknown sample can accordingly be interpreted by comparison to a similar score card which will 

be included in the final kit. The presence of three antibody bands at increasing intensity provides a greater 

dynamic range over which to interpret assay results; however, further evaluations during Phase II will indicate 

whether a single band can effectively substitute for the three separate bands. 

When the test is optimized and validated, a similar scoring chart will be prepared with high quality color images 

of results from pedigreed samples representing different HIV subtypes and a range of known infection dates 

from early Recent to very Long Term. The requirement for a single chart with accurate results from several 

widely circulating HIV subtypes or clades is the basis for Specific Aims 1d and 2a, which require that all widely 

circulating HIV subtypes show equivalent results. 

Research Strategy Page 119

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
 

Peptides for rapid incidence test. While 

the original IDR-M protein was produced by 

CDC as a recombinant containing tandem 

gp41 sequences covering different sets of 

HIV clades, we determined that the high 

hydrophobicity of the large rIDR-M protein, 

even after incorporation of hydrophilic 

linkers, prevented solubility in buffer over a 

wide concentration range. The high 

hydrophobicity also limited the possibilities for synthesis 

of the soluble conjugates required for the antibody 

detection format described above. Additionally, StrAv 

and HRP conjugates synthesized from recombinant 

rIDR-M showed strong association tendencies, leading 

to non-specific signal from binding with immobilized 

biotin in the absence of antibodies. To circumvent these 

problems, we generated synthetic peptides 

recapitulating each of the tandem gp41 sequences in 

the rIDR-M protein. To optimize the synthesis method 

for conjugates from hydrophobic peptides, we selected 

one peptide (IDR-M1) covering HIV subtypes 

A,B,C,F,G,H,J,K and recombinant forms AG,AB,AC,BF 

and BG [13] and combined it with hydrophilic linkers 

used for conjugation. We also synthesized the three 

peptides contained within rIDR-M in a biotinylated form 

with additional hydrophilization by linkage with a 

polyethylene glycol spacer. All peptides were adequately immunoreactive as antigen complexes with 

additionally hydrophilized StrAv. The mixture of conjugated individual peptides provided much higher sensitivity 

than rIDR-M, possibly due to greater availability of the antigenic epitopes in the synthetic peptide configuration 

(Figure 7). Covalent conjugates of IDR-M1 with StrAv and HRP with additional hydrophilic linkers added during 

conjugation demonstrated good solubility and complete absence of non-specific association, making these 

Figure 4. Comparison of two antibody capture methods for rapid 

incidence tests with two-strip format +/- dissociation reagent, on 

SeraCare Incidence/Prevalence Panel PRB601. 

Figure 5. Proposed rapid HIV incidence test 

cassette design and scoring chart. Mock up of 

cassette with strips inserted after running. 

 X: Long-term infection with high LAg ODn; Y: 

Long-term infection with LAg ODn near LAg 

ELISA cut-off; Z: Recent infection. 

Sample windows: 

C- Control non-treated sample window 

D - Window for sample with dissociation reagent 

X Y Z 

Figure 6. Scoring chart for HIVI rapid incidence test interpretation. R= 

Recent; LT = Long-term infection. C- Control non-treated sample window. D - 

Window for sample with dissociation reagent.

Figure 7. Comparison of sensitivity of synthetic peptides vs. recombinant 

IDR-M in HIVI rapid incidence test. rIDR-M and peptides M1, M2 and M3 at 

equimolar concentration as streptavidin conjugates. Detection with antihuman IgG-HRP. 

Research Strategy Page 120

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
conjugates well suited for antibody detection in a format with two peptide conjugates. The same strategy for 

hydrophilization will be applied for the other two rIDR-M peptides, which cover clades D, AD and AE.

The HIVI rapid test with the hydrophilic IDR-M1 peptide has very high analytical sensitivity. We demonstrated 

that some high positive samples can produce positive signal at dilutions up to 13 million, 10-20 times more 

sensitive than in an ELISA version of the test. This high sensitivity provides the possibility to explore use of 

oral fluid/saliva as the sample in place of serum in future assay versions, which would enable replacement of a 

blood draw with a non-invasive sampling procedure. In a preliminary experiment, the HIVI rapid test with IDRM1 detected HIV antibodies in saliva, which correlated well with detection in paired plasma samples (Figure 8). 

The saliva/plasma HIV panel was provided by the University of California at San Francisco SCOPE study. 

Testing HIV serum panels with known Recent/Long Term classification based on LAg ELISA (CDC). 

A serum panel originally from BocaBiolistics (Coconut Creek, FL) comprising 132 samples and a second panel 

from SeraCare comprising 89 samples were evaluated with the prototype HIVI rapid test using IDR-M1 

peptide. Results for these panels obtained with the rIDR-M-based LAg ELISA were provided by CDC for 

comparison. Interpretation for the HIVI is based on visual analysis of the intensity of color in test lines. The 

LAg ELISA’s ODn values correlated >98% for Recent and >99% for Long Term samples. Four samples were 

negative in both the LAg ELISA and the HIVI rapid test. Table 1 compares strip photographs with ELISA data 

for selected samples representing recent infection with ODn values in a medium range and close to the ELISA 

cut-off of 1.5 ODn, and for long term samples selected because their line color intensity in the absence of 

dissociation reagent is close to that of Recent samples. With one exception (sample 11-SC-0025), the Recent 

samples show a significant decrease in signal intensity in the presence of dissociation agent, while the Long 

Term samples show equivalent intensities. The two strip format thus provides unique visual discrimination 

between Recent and Long Term infection. The data as summarized in Table 2 clearly demonstrate excellent 

correlation between the two tests. 

Table 1. Examples of HIVI rapid test with LAg-defined Recent and Long Term infection. 

Figure 8. Paired plasma/saliva HIV panel tested with HIVI rapid incidence lateral flow test, detecting IgG, IgM and IgA 

antibodies. Separate detection lines correspond to increasing antibody binding level, not separate antibody classes. 

Research Strategy Page 121

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Phase I Progress Summary: 

1. Hydrophobic peptides from rIDR-M 

were adapted for use in an assay 

format with two antigen conjugates 

(StrAv and HRP) that offers multiple 

advantages for antibody testing in a 

rapid test format, requiring one step 

for antibody labeling and capture in 

a test line. 

2. Peptide conjugates from the major 

rIDR-M peptide that covers multiple 

subtypes (A,B,C,F,H,J,K and 

recombinants AC,AB,AC,BF,BG), 

and biotinylated forms of peptides for clades AE, D, and AD were synthesized and hydrophilized. 

3. A new approach for one step avidity testing based on combining antigen–antibody binding and dissociation 

reagent treatment was developed. 

4. New dissociation reagents were developed that are compatible with HRP, do not inactivate HRP activity, 

and can be conveniently incorporated into the sample addition step to prevent complex formation between 

low-avidity antibodies and peptide conjugates. 

5. Stable dry forms of dissociation reagent were developed for a separate sample application zone on lateral 

flow strips, as a potential alternative to the liquid form. 

6. A stable dry form of color developer/substrate that can be integrated into a lateral flow cassette was 

developed. 

7. The 2-strip design for the HIVI rapid test, with multiple test zones that improve its ability to discriminate 

samples based on antibody titer in addition to comparison of antibody avidity was further optimized. 

8. A prototype two-strip lateral flow cassette design was developed for use with either liquid or dry forms of 

substrate, both enabling an assay time <12 min from sample application to result. 

9. A scoring chart for simple and convenient visual interpretation of rapid test results was proposed. 

10. Extensive testing of an HIVI rapid test prototype using the IDR-M1 peptide with an HIV panel characterized 

with LAg ELISA data demonstrated more than 98% agreement with ELISA interpretation. 

11. The high sensitivity of the prototype HIVI lateral flow test using the IDR-M1 and several other HIV peptides 

for antibody detection was demonstrated. . 

12. The capability of the HIV rapid test for detection of HIV antibodies of multiple clades was confirmed by 

testing an HIV serum panel including clades A, B and C (sera from multiple sources). 

RESEARCH PLAN 

The overall objective of the proposed Phase II project is to optimize and configure the prototype HIVI rapid test 

for scalable manufacture, to carry out a field evaluation at several sites, to validate the optimized assay, to 

publish the data and submit for an FDA waiver for population surveillance use. Immunetics will be responsible 

for the overall project including work performed by collaborators, final assay design and development, bulk 

reagent manufacture, assembly and QC, retrospective and prospective field evaluation, and submission 

preparation and follow-through. Consortium partner Diagnostic Innovations (DI) will carry out reagent 

development and optimization, while Design Consulting Network (DCN) will perform optimization and scale-up 

of test strip manufacturing processes as well as diagnostic cassette mold design, manufacture and assembly. 

Retrospective and prospective field studies of HIVI rapid test performance aimed at supporting FDA waiver and 

CE mark submissions will be carried out in collaboration with CDC, MHRP, and BSRI. Immunetics will manage 

the project in accordance with our Quality System and Design Control guidelines. 

Product Definition. 

The target specifications for an HIV incidence test have been summarized in a recent paper by Hallett et al. 

which represents the consensus of the HIV Incidence Assay Working Group convened in a 2011 meeting 

sponsored by NIH and the Bill and Melinda Gates Foundation [10]. In Table 3, we compare the specifications 

of our HIV incidence rapid test with those proposed in this paper. Key attributes of an incidence test are the 

mean duration (w) and the false recency rate (FRR). The mean duration indicates the time at which an 

individual converts from “recent” to “established” infection. The false recency rate reflects the inaccuracy of the 

Table 2. Comparison of LAg ELISA with rIDR-M peptide vs. HIVI rapid test 

with IDR-M1 peptide conjugates. 

Research Strategy Page 122

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
test in classifying longstanding infections as recent. The LAg ELISA as the current standard in the field 

demonstrates a mean duration in the range of 4 – 5 months, and a false recency rate of slightly less than 2% 

[15,16]. Our preliminary data show correspondence between the HIVI rapid test and the LAg test of > 95%, 

suggesting that the HIVI rapid test will yield mean duration and FRR values similar to those observed for the 

LAg ELISA, which meet the target criteria below. With respect to other criteria, the HIVI rapid test is designed 

to meet the intended use on target populations comprising all HIV clades, and to meet requirements for sample 

type and volume, infrastructure and training, storage and shipping, and shelf life. As Immunetics is ISO13485 

certified and manufactures products under GMP, that requirement will be met; the need for regulatory 

clearance by FDA will be determined by the proposed claims. Previous HIV incidence tests have been exempt 

from FDA approval based on their use for population studies but not individual diagnosis; should the HIVI rapid 

test be used for the same purpose, it is anticipated that it will be exempted from FDA review. However, given 

the potential to use the test for diagnostic purposes based on the high diagnostic potential of the IDR-M 

antigen, the possibility to pursue FDA approval in the future will be considered.

Phase II Research and Development work will comprise: 

Specific Aim 1: Complete development of an optimized HIV incidence rapid test based on the rIDR-M 

antigen or synthetic peptides derived from it. 

Aim 1a. Optimization of antibody capture format, colorimetric detection system, dissociation conditions, 

interpretation criteria, test strip format and housing to yield <2% false recency compared to LAg ELISA. 

Activities will include:

· Synthesis of the StrtAv and HRP conjugates from two IDR-M peptides (M2, M3) specific to clades AE, 

D, and AD using hydrophilization approach validated for M1 peptide. Analyze possibility for synthesis of 

StrAv and HRP multi-peptide conjugates containing two or all three peptides in one conjugate without loss 

of solubility and without tendency to self-association. 

· Optimization of the rapid test with all peptides covering the full spectrum of IDR-M specificity using panels 

of HIV positive samples representing all major subtypes. 

Table 3. Target specifications for an HIV incidence assay. From Incidence Assay Critical Path Working Group (2011). 

More and Better Information to Tackle HIV Epidemics: Towards Improved HIV Incidence Assays. PLoS Med 8(6): 

e1001045. Published 06/14/2011.

Research Strategy Page 123

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
· Evaluation of differences between two antibody detection methods: one for simultaneous detection of all 

classes of anti-peptide antibodies (method of choice with two peptide conjugates) and methods with 

secondary detection reagents binding IgG antibodies as in conventional LAg ELISA. 

· Optimization of binding capacity of reagents in three tests lines to provide better discrimination of 

differences in antibody titer. Comparison vs. a single test line for greater simplicity. 

· Finalization of development of stabilization chemistry to produce strips with dry peptide conjugates, 

dissociation reagent, substrate reagents and for liquid sample diluents . 

· Introduction of two-color (color-coded) tracking dye system allowing simple visual monitoring to verify that 

test strips are being run with correctly diluted sample. 

· Development of single dose packs with wash buffer. 

· Comparison serum and plasma as sample matrix for rapid test. 

· Evaluation of use of dry tube or filter paper-dried serum/plasma samples for rapid incidence testing. 

· Evaluation of commercially available plasma separation devices for preparation of plasma for rapid 

incidence testing from whole blood 

· Finalization of development of cassette design optimized for new detection system in two versions, with dry 

substrate reagent and for use with liquid substrate reagent. 

· Development of storage materials and conditions for completely assembled tests (packaging materials, 

desiccants). 

· Development of QC criteria for peptide conjugates, substrate reagents and dissociation reagents. 

· Development of a simple approach for result interpretation using a scoring chart with representative images 

of test strips showing recent or long-term HIV band patterns obtained with samples of known infection 

status based on LAg ELISA criteria. 

The final stages of rapid test development at Immunetics will include scale-up of bulk reagent manufacture, 

peptide conjugates, substrate system reagents developed at Diagnostic Innovations, and writing and validation 

of manufacturing and QC procedures. QA reagents and procedures will be developed for in-process QC to 

verify that each lot of the rapid test detects antibodies to all HIV peptides included on the test strip. 

Aim 1b. Preparation and validation of plasma controls (incident, prevalent, negative) using dried tube 

specimens. Validation will involve comparison with standard controls’ ability to detect introduced error. 

Correlation of >95% will signal success. Activities will include: 

· Development of dry tube forms of Positive and Negative control samples for rapid test kits. Dry controls 

provide longer term stability than liquid controls and are less demanding in transport and storage. The 

method described by Ramos et al. for preparation of air-dried control sera will be compared with 

preparation by lyophilization. Air dried controls possess two disadvantages: the requirement for overnight 

drying and a similar requirement for overnight rehydration. Lyophilization can be carried out more rapidly 

and will result in a dry preparation that can be resolubilized within seconds to minutes. Immunetics has 

experience with lyophilization procedures and will prepare lyophilized controls in its pilot-scale lyophilizer in 

the Manufacturing Dept. Stability and reactivity of controls prepared by various protocols will be compared 

to select an optimal protocol for production of controls for HIV rapid incidence test kits. 

Aim 1c. Simultaneous preparation of instructions for use, interpretation spreadsheet and training package, 

including photographs or video of test method process and interpretation. 

· Instructions and training package will be prepared and tested on naïve operators to optimize them prior to 

external evaluations. Photos and video will be generated using available equipment and expertise at 

Immunetics. The interpretation spreadsheet will be prepared in Excel and made available for downloading 

from Immunetics’ website by test users. The spreadsheet will facilitate record keeping, accuracy and 

objectivity in interpretation by providing a standard form for documentation of results.

Aim 1d: Design of cassette, transfer to manufacturing and manufacture of pilot lots of the rapid test for 

laboratory and field evaluations. 

· DCN In collaboration with Diagnostic Innovations will optimize and perform manufacturing operations for 

the rapid test cassette and test strips. An injection molded cassette will be designed to meet the specific 

characteristics of the HIV rapid test (fluid volume, diagnostic line placement, delivery of peroxide substrate) 

and to allow simple, low-cost assembly. Initial cassette prototypes will be produced and tested to enable 

design refinement. Three pilot lots of 1-2,000 cassettes each will be produced to meet the anticipated 

needs of test evaluations in-house and at field sites. The molded cassette will likely be a derivative design 

Research Strategy Page 124

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
based on existing cassettes which applicants have found suitable for the rapid test with some minor 

modifications. 

· Test strip production involves sequential impregnation, dispensing, drying, cutting and laminating steps, 

each of which must be carefully optimized and controlled to ensure reproducible and sensitive test 

performance. Accurate and consistent dispensing of reagents will be preferentially performed using noncontact ink-jet technology (e.g. Bio-Dot). Strip manufacture will be done at DCN which has all equipment 

necessary for this process. A batch method will be applied for application of control and test line reagents 

on diagnostic membranes attached to a backing card with subsequent membrane blocking and drying. 

Cards with diagnostic membranes will then be loaded with conjugate pads and sample application pads, or 

additional plasma separation material. All work will be performed under humidity control. Completely 

assembled cards will be cut on rotary cutters. Immunetics will provide positive and negative control sera 

for Quality control. Prototype test kits will be evaluated on a small scale at one or more collaborating sites 

and at Immunetics to obtain input on usability and preliminary performance and enable improvements, if 

needed. Stability studies. Reagents and completely assembled devices will be subject to real time stability 

studies at 4°C, room temperature (20-25°C), and accelerated stability at 37°C. Performance of each lot of 

reagents and assembled devices will be verified using a QC panel comprising 10 - 12 samples containing a 

range of incidence and prevalence sera, and negative controls. The target shelf life for the rapid test will 

be 12 months at room temperature. 

Aim 1e: Field testing of the rapid test for accuracy, ease of use, reproducibility, interpretation.

· We will design and carry out a study comparing the HIV incidence rapid test with the conventional LAg 

ELISA method. Immunetics has extensive experience in the design, management, execution and analysis 

of clinical trials in support of regulatory submissions (its last clinical trial resulted in a 510(k) approval by 

CBER in August 2013). IRB approval will be obtained for the protocol, potentially exempting it from human 

subjects regulations as individual subjects will not be recruited but testing carried out anonymously. 

· The market for HIV incidence assays has been well understood since at least the mid-1990s to be 

relatively small and very price-sensitive, yet extremely important to stakeholders, including national and 

regional governments, so-called normative organizations that set standards and provide guidance, other 

NGOs, charities, and academic and research institutions [10]. Given this situation, many of these 

organizations, as well as some small or civic-minded (or both) for-profit companies, have tried different 

approaches to developing HIV incidence assays and evaluating what they have developed. These efforts, 

in turn, have led over time to some consensus as to steps required for validation, and we will be guided by 

this consensus. An example of the guidance for validation of an HIV incidence test, used at the CDC [Y. 

Duong], is shown in Table 4. 

Objectives Specimen Type Sample 

Size HIV Subtype or Cohort Output Result Pass Criteria 

Laboratory Validation 

Optimization Serum/plasma >100 runs on 

controls 

Applicability to all subtypes Assay precision - %CV for 

controls 

<10% (in the dynamic range) 

Commercial kit or 

accessory kit for 

modifying diagnostic 

kit 

Serum/plasma and DBS N/A N/A Manufactured product Manufacturer can produce multiple 

lots consistently by passing 

stringent external QC criteria 

Mean duration of 

recency (ω) 

Seroconversion panels 

(ART-naïve) 

20-30 panels 

per subtype 

A, B, C, D, AE, and/or other 

CRFs 

· Biomarker kinetics 

· ω for each subtype 

· ω overall 

· Defined for single subtype 

· For worldwide application, 

statistically equivalent ω for all 

subtypes 

FRR · >1 year 

(ART-naïve) 

· AIDS 

500 per study 

population 

Minimum 

2-3 subtypes 

Level of misclassification <2%

FRR Elite Controllers 20-30 Minimum 

1 set of specimens 

Level of misclassification <2%

Impact of ART Individuals on ART with 

clinical information on 

ART use 

50-100 Minimum 

1 subtype 

Level of misclassification Inclusion/

Exclusion criteria for ART use 

Table 4. Validation and characterization for HIV incidence assays – CDC guidance

Research Strategy Page 125

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Field Validation 

Incidence Estimates Cross-sectional survey 

populations 

Varies Minimum 2-3 survey populations, 

containing subtype(s) for which 

an assay will be used 

Comparison with modeled 

or observed incidence, 

plausibility 

Assay-derived incidence estimate 

should be similar to other methods 

Sub-category risk 

analysis 

Cross-sectional survey 

populations 

Varies Minimum 2-3 survey populations, 

containing subtype(s) for which 

an assay will be used. 

Comparison with observed 

risks, plausibility 

Odds ratios should be plausible 

and comparable to observed risks 

We have modified this process somewhat to gain field experience with a prototype assay. The prototype 

assay will be built with the final antigen formulation, and will have demonstrated both satisfactory 

reproducibility and excellent correlation (>98%, taking into account possible differences in the cutoff) with 

the LAg lab-based assay across multiple widely occurring HIV Group M subtypes or clades, a major 

requirement for a test expected to have worldwide distribution. (Differing classification as recent or long 

term for different subtypes will lead to unacceptably inaccurate estimates of incidence in some 

populations.) When this milestone has been reached, an evaluation of operability, or the quality of results 

from field-trained individuals in two sites (one MHRP and one CDC site) will be done. Feedback from this 

evaluation will be used to make final adjustments in the test configuration itself, if required, but especially in 

the Instructions for Use (IFU) and the training package. 

After the final test kit formulation has been transferred to Manufacturing and three lots have been 

satisfactorily made, validation largely according to the above table will begin. Here we are fortunate in that 

large repositories of plasma samples with incidence test results from LAg and various more complex RITAs 

(recent infection test algorithms), and with clinical data confirming recency or long term infection from 

several populations of interest, have already been assembled by CDC, CEPHIA (testing at BSRI) and 

MHRP, and these organizations will test the Immunetics HIVI rapid test against those samples. 

Populations included among the repository samples (see also the Table above) are 

· Seroconverters (individuals with known or closely estimated HIV infection dates) with HIV infections 

from several different subtypes and circulating recombinant forms). These samples will be tested first, as 

they are used to evaluate the mean duration of recency, which in turn sets the cutoff for the assay. 

Statisticians from CDC who have experience with this aspect of the evaluation will work with Dr. Parekh’s 

group and the Immunetics team to determine the MDR, for which the symbol is used. 

· False recency samples (from 1. individuals known to have been infected for more than a year but who 

test ‘recent’; 2. individuals with AIDS, whose immune systems have been degraded so that they also test 

recent; 3. elite controllers (individuals whose immune systems control their infections without anti-retroviral 

therapy, who also sometimes test ‘recent’) will be tested to determine or confirm a false recency rate (FRR) 

in different populations. If other aspects of the assay are satisfactory or better, but FRR is >2% in a given 

populations, exclusion criteria could be considered, or a RITA in which ‘recents’ are all confirmed (or not) 

by another incidence assay, by clinical information, or by reflexing to another test such as CD4 or HIV 

RNA. 

· Samples from individuals taking anti-retroviral therapy (ART), which is known to slow or seemingly 

abort the anti-HIV immune response will be tested to determine whether ART use is an exclusion criterion 

for the Immunetics HIVI rapid test. 

If the results of the laboratory validations confirm that the HIVI rapid test meets the goals established in the 

final column of the table above, field evaluations using prospective, sequential samples from populations 

under study, and comparing results with the incidence assay or RITA currently in use at the site, will be 

launched at two to four sites within and outside the U.S. by CDC and MHRP. In these studies, surveillance 

technicians working in-country in settings where a rapid test format is preferable to a high-volume system 

will be trained to run the Immunetics HIVI rapid test, and then will test up to 100 sequential samples as just 

described in cross-sectional survey populations for incidence estimates or sub-category risk analysis. 

Correlation of HIVI results with percent recency as determined by other means in this setting will be 

calculated. The CDC validation protocol above describes a goal for these studies of ‘similar’ incidence 

estimates, because the locally used method may be less well validated. Results will be analyzed by 

surveillance experts and reported in a publication or presentation. We anticipate that field evaluations will 

be scheduled to take place starting in the first half of year 3 of the grant. The epidemic’s evolution and 

multiple other factors will influence where surveillance is being done at that time, but sites will be chosen 

where different HIV-1 Group M subtypes are circulating. 

· Data will be collected in real time as studies proceed, and will be analyzed on an ongoing basis. 

Publications and presentations will be prepared as analysis becomes available. For statistical analyses of 

data and objective verification of study results, interpretation and conclusions, we will engage Dr. 

Research Strategy Page 126

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
 biological statistician. has assisted 

Immunetics in previous clinical studies with similar statistical analyses. 

Aim 2a. Analysis of HIVI rapid incidence test sensitivity, specificity and discrimination of recent vs long-term 

infections. 

· The capability of the HIVI rapid test to discriminate recent from long-term infection will be evaluated on 

well-characterized serum/plasma panels containing known incidence and prevalence specimens, as well 

as samples from elite controllers and ART-treated or non-treated individuals. The CDC LAg ELISA with 

false recency rate < 2 at cut-off of 1.5 will be used as the standard of comparison. Panels will be obtained 

from (see letters of support). will assist in requesting access to incidenceprevalence panels from CEPHIA (Consortium for the Evaluation and Performance of HIV Incidence 

Assays, http://www.incidence-estimation.com/cephiaqueries/cephiaDB/overview, supported by a grant 

from the Bill & Melinda Gates Foundation), including the 200-member Qualification Set and the 3,000 

member Evaluation Set which includes a preponderance of global, non-clade B sera. The HIVI rapid 

incidence test must also exhibit a level of sensitivity of detection of HIV antibodies roughly comparable to 

that of other HIV screening tests in order to serve the indicated use. Sensitivity will be evaluated using 

panels of well-characterized HIV-positive sera, low titer sera, seroconversion panels, and global clade 

panels, all of which are available within Immunetics’ current collection. Specificity will be tested on healthy 

blood donor sera, of which thousands are available in Immunetics’ freezers. 

Aim 2b. Evaluation of a rapid plasma separation device to enable whole blood testing. 

· The HIVI incidence rapid test will be adapted for testing of whole blood samples by a simple, independent 

plasma separation device (Pall, GE Healthcare, or MDI Membrane Technologies) designed for sample 

application and transfer of plasma to a diagnostic strip. Our collaborators at and 

 have extensive experience in development of whole blood rapid tests. Optimization of test 

performance in whole blood will be performed using a test panel prepared by spiking normal blood samples 

with a range of titers of HIV sera. The testing of whole blood samples will be evaluated at (see letter 

of support), which will have access to whole blood samples drawn from local HIV patients participating in 

the Phase I-initiated collection of samples from recently infected, newly diagnosed individuals 

(see letter of support). Assay performance on whole blood vs. serum/plasma will 

be compared with respect to accuracy of recency classification, and overall sensitivity and specificity. 

Aim 3. Prepare data from all studies for publication and for submission to FDA for waiver of approval to allow 

intended use for population surveillance, for submission for CE mark, and for other regulatory approvals as 

appropriate. 

· We intend to submit, together with our collaborators, results of evaluations of the HIVI rapid incidence test 

for publication in order to promptly disseminate information on its performance and availability. The 

regulatory situation worldwide will be monitored, and the Immunetics team and our collaborators will stay in 

touch with regulators and prepare submissions as soon as data analysis allows. As a test to be applied to 

a population for surveillance rather than to an individual for diagnosis, the HIV incidence rapid test will not 

be subject to FDA regulation as a diagnostic device. Previous HIV incidence tests including the BED 

ELISA which is commercially available from Sedia (http://www.hivincidence.com/uploads/LN-6011-

02_Product_Insert__BED_EIA__sm_.pdf) have been waived by the FDA based on the intended use for 

surveillance only, and the specific exclusion of diagnostic use. However it will be necessary to obtain CE 

mark registration for commercialization in Europe, and other regulatory requirements may pertain to other 

regions of the world. We will obtain CE mark registration through 

 of the world will be pursued on a 

case by case basis. We expect the regulatory environment to evolve over the next few years, and we plan 

to monitor it, and apply for clearances, approval, or waiver as appropriate, for an intended use for 

population surveillance.

Research Strategy Page 127

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Human Subjects.

IRB approvals will be sought for the proposed studies, although we anticipate that they may be considered 

exempt. Immunetics possesses FWA #8606 covering work with Human Subjects.

1. Risks to the subjects.

Human subjects involvement and characteristics.

The project’s goal is the development of a rapid assay for HIV incidence which will allow discrimination 

between recent and long-term HIV infection. In the course of the project, we will make use of panels of HIVpositive sera to be provided by CDC, MHRP (WRAIR/DOD), Blood Systems Research Institute (San 

Francisco), SeraCare and other sources. These sera were collected under IRB approvals by the source 

institutions which allow their use in our research project. CDC and MHRP will additionally carry out field studies 

of the rapid HIV incidence test. These studies will be carried out at existing study sites in various global 

locations (expected to include Africa and Asia) in conjunction with existing, IRB-approved protocols for HIV 

testing from these institutions. Thus, the proposed study under this Phase II grant will not involve recruitment of 

 No 

procedures will be performed on patients specifically for this study, as serum/plasma samples will have been 

collected as part of ongoing studies by the collaborating organizations. 

Protection against risk.

There will be no risk to patients’ health presented by this study, as no new procedures will be carried out for 

this study. The study will rely on serum/plasma samples collected as part of ongoing studies by collaborating 

organizations including CDC, MHRP, and BSRI. Clinical samples to be provided in the course of the study will 

be provided to Immunetics devoid of patient identifiers to protect individual privacy.

3. Potential benefits of the proposed research to the subjects and others.

As serum/plasma samples will be de-identified, there will be no human subjects and hence no direct benefit to 

them. The goal of the project is the development of a rapid test for discrimination of recent vs. long-term HIV 

infection. As no such rapid test is currently available, development of the proposed test will aid future public 

efforts which will ultimately affect HIV infected individuals. As such, the test resulting from this work will 

represent a significant asset to the global HIV prevention effort.

Protection of Human Subjects Page 128

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
4. Importance of the knowledge to be gained.

While the principal result of the project will be the development of a rapid test for discrimination of recent from 

long-term HIV infection, it is anticipated that the process of assay development will generate useful knowledge

regarding HIV peptide antigens, the immune response in HIV infection and immunoassay methods. The 

application of a novel rapid assay methodology will be demonstrated, and its discriminatory power, analytical 

sensitivity and specificity shown. A successful discriminatory test will set a significant precedent, providing an 

essential monitoring and diagnostic tool for future HIV incidence studies. The value of such information far 

outweighs the negligible risks posed by the study. Significant findings from the project will be published as 

scientific papers, while new intellectual property will be patented or protected.

Protection of Human Subjects Page 129

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Inclusion of Women and Minorities

Women and minorities will be included to the extent that they are represented in the population of 

individuals from whom samples have been or will be collected, as no subjects will be enrolled for this study 

and all samples will be de-identified. As the source regions from which samples will be obtained include the 

U.S., Africa and Asia, it is expected that a large percentage of samples will be obtained from individuals 

who correspond to minorities in the U.S. including individuals of black racial and African and Asian ethnic

origins. The exact distribution of genders and racial/ethnic origins in the sample population is not under our 

control, however, but dependent on the study protocols and organizations of collaborating organizations 

including 

Women &Minorities Page 130

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Program Director/Principal Investigator (Last, First, Middle): Garrett, Patricia.

Targeted/Planned Enrollment Table

This report format should NOT be used for data collection from study participants.

Study Title: Rapid Test for Recent HIV Infection

Total Planned Enrollment: 0

TARGETED/PLANNED ENROLLMENT: Number of Subjects

Ethnic Category Females Males Total

Hispanic or Latino 0 0 0 

Not Hispanic or Latino 0 0 0 

Ethnic Category: Total of All Subjects * 0 0 0 

Racial Categories

American Indian/Alaska Native 0 0 0 

Asian 0 0 0 

Native Hawaiian or Other Pacific Islander 0 0 0 

Black or African American 0 0 0 

White 0 0 0 

Racial Categories: Total of All Subjects * 0 0 0 

* The “Ethnic Category: Total of All Subjects” must be equal to the “Racial Categories: Total of All Subjects.”

PHS 398/2590 (Rev. 06/09) Page Targeted/Planned Enrollment Table Format Page

Planned Enrollment Table Page 131

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Inclusion of Children

Children will be included in this study to the extent that they are represented in the population of individuals 

from whom samples have been or will be collected, as no subjects will be enrolled for this study and all 

samples will be de-identified. The frequency of children in the population to be studied will not be under our 

control.

Children Page 132

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Bibliography and References Cited 

1. Granade, T.C., S. Nguyen, D.S. Kuehl, B. Parekh. (2013) “Development of a Novel Rapid HIV Test for 

Simultaneous Detection of Recent or Long-Term HIV Type 1 Infection Using a Single Testing Device.”

AIDS Res Hum Retroviruses, 29(1):61-7, DOI: 10.1089/aid.2012.0121 

2. A. Ramos, S. Nguyen, et al. (2013) “Generation of dried tube specimen for HIV-1 viral load proficiency test 

panels: A cost-effective alternative for external quality assessment programs.” JVM, 188:1-5. 

http://dx.doi.org/10.1016/j.jviromet.2012.11.036 

3. Garrett, P.E., M. Dowell, C. Barrett, C. Shayevich, H. Hjord, S. Philip. “Serial Plasma/PBMC Collections 

from Recently HIV-Infected Individuals.” Poster presentation, HIV Dx Conference, December, 2012. 

4. Duong, Y.T., M. Qiu, A. K. De, K. Jackson, T. Dobbs, A. A. Kim, J. N. Nkengasong, B. S. Parekh. (2012) 

“Detection of Recent HIV-1 Infection Using a New Limiting-Antigen Avidity Assay: Potential for HIV-1 

Incidence Estimates and Avidity Maturation Studies.” PLOS One, 7(3):1-9 

5. Busch, M. P., C. D. Pilcher, T. D. Mastro, J. Kaldor, G. Vercauteren, W. Rodriguez, C. Rousseau, T. M. 

Rehle, A. Welte, M. D. Averill, and J. M. Garcia Calleja. (2010). "Beyond detuning: 10 years of progress 

and new challenges in the development and application of assays for HIV incidence estimation." AIDS, 

PMID 20975514. 

6. Bharat S. Parekh, J. Anyanwu, H. Patel, M. Downer, M. Kalou, C. Gichimu, B. S. Keipkerich, N. Clement, 

M. Omondi, O. Mayer, C.-Y. Ou, John N. Nkengasong. (2010) “Dried tube specimens: A simple and costeffective method for preparation of HIV proficiency testing panels and quality control materials for use in 

resource-limited settings.” JVM, 163: 295-300 

7. Family Health International. Assays to Estimate HIV Incidence and Detect Acute HIV Infection: Global 

Landscape & Market Assessments. (2009) accessed 9/4/2013: 

http://www.who.int/diagnostics_laboratory/links/assays_to_estimate_hiv_incidence.pdf, 

8. Garrett, P. E., Phillip J. Norris, Keith Perry, Eric Delwart, Barbara Weiblen, Gregory Chiklis, Toby L. Simon, 

Mark Manak, Michael P. Busch, and Richard T. Schumacher. (2009). 20 Years of Research and 

Development Experience with HIV, HCV, and HBV Seroconversion Panels. Clinical Virology Symposium. 

9. Guy, R., J. Gold, J. M. Calleja, A. A. Kim, B. Parekh, M. Busch, T. Rehle, J. Hargrove, R. S. Remis, and J. 

M. Kaldor. (2009). "Accuracy of serological assays for detection of recent infection with HIV and estimation 

of population incidence: a systematic review." Lancet Infect Dis 9(12): 747-759, PMID 19926035. 

10. Hallett, T. and The Incidence Assay Critical Path Working Group (2011). "More and Better Information to 

Tackle Epidemics: Towards Improved HIV Incidence Assays." PLoS Med 8(6): e1001045. 

doi:10.1371/journal. pmed.1001045 

11. Le Vu, S., J. Pillonel, C. Semaille, P. Bernillon, Y. Le Strat, L. Meyer, and J. C. Desenclos. (2008). 

"Principles and uses of HIV incidence estimation from recent infection testing--a review." Euro Surveill 

13(36), PMID 18775292. 

12. Parekh, B. S., D. L. Hanson, J. Hargrove, B. Branson, T. Green, T. Dobbs, N. Constantine, J. Overbaugh, 

and J. S. McDougal. (2011). "Determination of mean recency period for estimation of HIV type 1 Incidence 

with the BED-capture EIA in persons infected with diverse subtypes." AIDS Res Hum Retroviruses 27(3): 

265-273, PMID 20954834. 

13. Wei, X., X. Liu, T. Dobbs, D. Kuehl, J. N. Nkengasong, D. J. Hu, and B. S. Parekh. (2010). "Development 

of two avidity-based assays to detect recent HIV type 1 seroconversion using a multisubtype gp41 

recombinant protein." AIDS Res Hum Retroviruses 26(1): 61-71, PMID 20063992. 

14. Soroka, S.D., T. C. Granade, D. Candal, B. S. Parekh (2005) “Modification of Rapid Human 

Immunodeficiency Virus (HIV) Antibody Assay Protocols for Detecting Recent HIV Seroconversion” 

Clinical and Diagnostic Laboratory Immunology, 12(8): 918–921. 

15. Meeting Report, WHO Working Group on HIV Incidence Assays, Annual Meeting 18-24 August 2011, 

Atlanta, Georgia, USA, 

http://www.who.int/diagnostics_laboratory/links/who_incidence_meeting_draftreport_december2011.pdf 

16. WHO/UNAIDS Technical Update on HIV incidence assays for surveillance and epidemic monitoring, 

Geneva, 30 May 2013, 

http://www.unaids.org/en/media/unaids/contentassets/documents/epidemiology/2013/2013_TechnicalUpda

te_WHO_UNAIDS_HIVincidenceAssays.pdf 

17. MDI Membrane Technologies, Rapid Plasma Separation Device 

http://www.mdimembrane.com/Products/Immunodiagnostics/Products/Rapid%20Plasma%20Separation%20Device.html#

References Cited Page 133

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
Consortium Arrangements

Overview. This project will be carried out principally at three sites: 

 have overall responsibility for 

administering the grant and managing the work of all consortium partners, including responsibility for all grant 

finances. The investigator responsible for carrying out the work at each site will be responsible for that site’s 

finances and work product. All consortium participants will abide by NIH policies for grantees and will maintain 

grant financial records so as to meet NIH financial audit requirements. Disagreements between consortium 

participants will be resolved by good faith discussions or if necessary, by decision of the Principal Investigator. 

Dr. Patricia Garrett, the Principal Investigator, will organize and oversee the performance of all grant work, 

directly handling the relationships among the organizations developing the assay and those working with us to 

perform various evaluation tasks outside of the consortium. employee at 

 Dr. Garrett originated the idea for the joint 

project that led to the Phase I SBIR, and was Principal Investigator for the Phase I SBIR grant held by 

until . She 

worked for and its predecessor company Boston Biomedica for more than 24 years. During that 

time, she was responsible for multiple new panel and control products, and managed many different areas of 

the growing company, including clinical trials, product development, quality and regulatory, CLIA licensed 

clinical laboratories, business development and intellectual property. She has worked in HIV incidence since 

before 1999, and has managed CDC-funded to provide serial samples from 

individuals whose dates of HIV infection can be closely estimated.

 

, will direct the assay 

development work at Immunetics. He has been Principal Investigator on over a dozen grants and contracts 

from the National Institutes of Health and the Centers for Disease Control and Prevention. He has developed 

ELISA and Western Blot assays for a range of parasitic, bacterial and viral diseases including Lyme disease 

ELISA and Western Blot, Cysticercosis Western Blot, Echinococcosis Western Blot, Babesia microti ELISA 

and Western Blot, T. cruzi Western Blot, Human Granulocytic Ehrlichiosis (HGA) ELISA and Western Blot, 

Anthrax ELISA and Western Blot, H. pylori Western Blot, Bartonella henselae Western Blot, HIV Western Blot, 

Ehrlichia risticii Western Blot, SARS ELISA, Parvovirus B19 Western Blot, and others. Dr. Levin has brought a 

number of these assays from conception to final product, organized and managed clinical trials to support FDA 

submissions, developed means to scale up manufacturing, and launched the FDA-approved tests as in vitro 

diagnostic test kits.

The Principal Scientist,

as a spin-off in order to develop rapid test methods and 

technologies. He has specialized in the area of rapid test chemistry for over 30 years, and has developed 

numerous tests for a wide range of diagnostic applications. His expertise includes synthesis of 

immunochemical reagents, devising novel detection strategies based on various means of signal amplification, 

and design and construction of complete rapid test systems. Dr. Kovalenko’s group at 

will concentrate specifically on developing antigens, conjugates, substrates, and membrane assay 

compositions that are the key elements of the HIV incidence rapid test. The resources, equipment, and staff at 

 are appropriate for these R&D activities.

contribution will be commercial product development and test kit production. 

 has a long history of development of ELISA and Western Blot assays for infectious diseases, and 

has achieved regulatory approval and commercialized many of these in the form of diagnostic kits for clinical 

laboratory use. Immunetics will provide the complementary capability to carry out assay evaluation studies 

using clinical specimens, to develop the assay in kit format and launch it commercially. Furthermore, 

Immunetics has filed a patent application covering the new rapid test technology for multiple other applications. 

To develop and launch a commercial HIV incidence rapid test, Diagnostic Innovations, Immunetics and 

 will cooperate to share the technology owned by each for purposes of this 

project. Dr. Kovalenko will coordinate work between chemistry development at Diagnostic Innovations, 

development of diagnostic cassette and integration of strip design at and 

technology transfer to production at Immunetics.

Consortium/Contractual Page 134

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
 

Consortium/Contractual Page 135

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
In summary, the contributions are necessary to carry out the 

proposed project. The combination of strengths and capabilities offered by this consortium and scientific 

partnership will be melded with a straightforward division of responsibilities, and the history of productive work 

by Drs. Garrett, Kovalenko and Levin will ensure a high probability of success in achieving the project’s short 

and long term goals.

specializes in rapid development, manufacture and commercialization of POC 

tests in various formats - lateral flow, flow through, microfluidic and ELISA for any market segment. The 

company is ISO 9001-2008 Registered and operates under design controls and GMP as required. can 

design, develop, integrate, validate and transfer to manufacturing all aspects of a point of care assay system, 

including the assay chemistry and biology, reagents, conjugates, strip design, cassettes, and sample handling 

devices. has performed over 40 successful product development programs for companies in the rapid 

testing field, in application areas as diverse as medical diagnostics, veterinary diagnostics, bio-warfare, 

forensics, food microbiology and agricultural product testing. 

Additionally, of providers includes experts in all aspects of rapid diagnostic device design and 

development, including reagent developers, reader designers, cassette design and development companies, 

molders, materials suppliers and manufacturing equipment suppliers, as well as consultants in areas including 

regulatory affairs, quality systems, market analysis and product distribution. will be responsible for 

development of the cassette housing for the HIV incidence lateral flow test, strip integration and manufacture of 

pilot lots of rapid test strips and cassettes. will be provided with all key reagents, peptide conjugates and 

substrate system reagents from Immunetics, and will provide manufacturing documentation for all procedures 

in a package that can be provided to high-volume manufacturing companies for eventual commercial 

production on a larger scale. will communicate with a regular 

basis, including an initial in-person meeting and periodic visits to assess progress and participate in critical 

decisions regarding product development.

CDC. The U.S. Centers for Disease Control and Prevention has led the effort to develop tests for HIV 

incidence worldwide, and has funded numerous projects in the U.S. and in resource-constrained regions to 

build repositories of samples to evaluate these tests. The current most widely used HIV incidence test 

worldwide (BED, for the HIV subtypes covered), and the current most advanced laboratory incidence test (LAg, 

for Limiting Antigen) were both developed at CDC by . has 

performed, documented, and published thorough validations of their and other candidate incidence test 

methods. This group has worked with commercial and non-profit organizations interested in assays, sample 

panels or evaluations of HIV incidence tests for many years. are funded in part by 

PEPFAR (President’s Emergency Plan for AIDS Relief), and they also work in the field in Africa and Asia to 

help agencies in these countries estimate HIV incidence in their general populations and populations at risk.

 also developed a prototype rapid HIV incidence test, citing areas needed for improvement 

that will inform our efforts [1]. Since Immunetics first contacted CDC about our interest in using the 

breakthrough technology from to develop an HIV incidence assay and offered preliminary data for review, 

CDC has shared samples of the antigen that is the basis for the LAg assay as well as plasma samples with 

data from both LAg and BED assays. CDC has communicated the serious need throughout the world for a 

simple, accurate rapid test for HIV incidence, and has strongly encouraged the Immunetics team to move 

forward with this assay. will assist with the optimization of the assay, particularly advising 

on the decision for the cutoff to distinguish recent from long term HIV infection, and will conduct laboratory and 

field studies to evaluate the assay once it is optimized. As a U.S. government agency, CDC cannot receive 

funding under this grant, but will provide services at its own expense, and is accordingly not included in the 

grant budget. is listed as a key person on the grant in the capacity of consultant.

Consortium/Contractual Page 136

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
 Ten Years of Progress and New Challenges in the 

Development and Application of Assays for HIV Incidence Estimation from Surveys. AIDS 24:2763-2771, 

2010). The group is currently funded by the Gates Foundation in a 3-year initiative called CEPHIA with the UK 

Health Protection Agency to evaluate 10 lab-based incidence assays, and as part of that effort has assembled 

panels of more than 3000 pedigreed samples for these evaluations. will test the optimized Immunetics 

HIVI rapid test with these samples, comparing the data generated with results already gathered from LAg and 

more complex HIV incidence determination algorithms. They will also undertake a small study comparing fresh 

plasma samples generated by conventional centrifugation to plasma from membrane-based whole blood 

separation systems to determine whether membrane-separated plasma delivers equivalent results. 

himself is perhaps the leading world expert in HIV diagnostics, and will function as an advisor to Immunetics in 

addition to leading the studies described here. is listed as a key person on the grant.

Consortium/Contractual Page 137

Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
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Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia
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Principal Investigator/Program Director (Last, first, middle): Garrett, Patricia