Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol
Phase: NA
Conditions: Healthy
Sponsor: Abbott Diagnostics Division

 
 
COVER PAGE 
Abbott Laboratories 
 
 
Official Title of the Study:  Abbott Laboratories Alinity s Blood Screening Assays – Clinical 
Evaluation Protocol 
 
NCT Number:  NCT03285295 
 
Type of Document:  Study Protocol 
 
Protocol Number:  9DY-02-14U01-03 
 
Version:  5 
 
Date of Document:  April 18, 2018 
 
Date of Document Approval:  April 24, 2018 
 
 

Protocol No. 9DY-02-14U01-03 
 
Confidential Information 
This material is the property of Abbott Laboratories and must not be disclosed or used, except as authorized in writing by Abbott Laboratories. 
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Abbott Laboratories 
Alinity s Blood Screening Assays - Clinical Evaluation Protocol 
 
WARNING: 
 
FOR PERFORMANCE EVALUATION, ONLY 
 
FOR INVESTIGATIONAL USE, ONLY. The performance characteristics of this product 
have not been established. No clinical decision or patient notification should be made based on 
the results obtained with this product. 
 
Protocol No.: 9DY-02-14U01-03 
Version:         5 
Date:              April 18, 2018 
                        Incorporating Amendment 4 
Rationale for amendment: Incorporates Scientific Changes  
 
Abbott Monitors: 
Tuan L. Bui 
Nira Joshi 
Clinical Research Manager 
Sr. Clinical Research Assoc. 
Phone: 224.668.4702 
Phone: 224.667.9672 
e-mail: tuan.l.bui@abbott.com 
e-mail: nira.joshi@abbott.com 
 
Susan Sullivan                                             
John Birdsall 
Sr. Clinical Research Assoc.                     
Specialist Medical Affairs. 
Phone: 224.668.7949                                  
Phone: 224.668.2276 
e-mail: susan.sullivan@abbott.com           
e-mail: john.birdsall@abbott.com 
 
 
Address/Fax: 
Abbott Laboratories                    
 
for all monitors  
 
 09TM, CP1 
 
100 Abbott Park Road 
Abbott Park, Illinois 60064-6070 
Fax: (224) 667-7836 
 
Part or all of the information in this protocol may be unpublished material. Accordingly, this 
protocol is to be treated as confidential, and restricted to its intended use. If any portion of this 
unpublished material is desired for purposes of publication, authorization is to be obtained 
from Abbott Laboratories. 
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Protocol No. 9DY-02-14U01-03 
 
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Table of Contents 
  
I. 
Introduction ................................................................................................................ 4 
II. 
Objectives .................................................................................................................. 5 
III. Study Design .............................................................................................................. 5 
A. Overview .............................................................................................................. 5 
1. System Reproducibility .................................................................................. 6 
2. Specimen Testing ........................................................................................... 6 
3. Additional System Testing ............................................................................. 6 
B. Ethics .................................................................................................................... 6 
C. General Schedule of Events ................................................................................. 8 
D. Comparator Method ............................................................................................. 8 
E. Supplemental Testing ........................................................................................... 9 
F. Follow-up Specimens ........................................................................................... 9 
IV. Operating Conditions ............................................................................................... 10 
A. Material and Equipment ..................................................................................... 10 
1. Product Description ...................................................................................... 10 
2. Product Storage and Handling Requirements .............................................. 11 
3. Instructions for Use ...................................................................................... 11 
B. Environment ....................................................................................................... 11 
C. Testing Personnel Requirements ........................................................................ 12 
V. 
Product Accountability ............................................................................................ 12 
VI. Study Methods and Procedures ................................................................................ 12 
A. Specimen Selection ............................................................................................ 12 
1. Study Population/Sample Size ..................................................................... 12 
2. Whole Blood Donor and Plasmapheresis Specimens .................................. 13 
3. Specimen Handling, Storage, and Accountability ....................................... 14 
B. General Study Procedures .................................................................................. 16 
1. Assay and/or System Configuration ............................................................. 16 
2. Instrument System General Procedures ....................................................... 16 
3. Assay Calibration ......................................................................................... 16 
4. Assay Training ............................................................................................. 16 
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Protocol No. 9DY-02-14U01-03 
 
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5. Quality Control Validity Criteria ................................................................. 17 
6. Troubleshooting Quality Controls .................................................................... 17 
7. Method for Handling Retests and Error Codes ................................................. 18 
8. Additional Troubleshooting .............................................................................. 18 
C. Testing Procedures .................................................................................................. 18 
1. System Reproducibility ..................................................................................... 19 
2. Specimen Testing .............................................................................................. 19 
VII. Methods for Data Collection and Documentation ........................................................ 22 
A. Instrument Data Capture ......................................................................................... 22 
B. Case Report Forms .................................................................................................. 22 
C. Supplemental Data Transfer .................................................................................... 22 
VIII. Adverse Events.............................................................................................................. 23 
A. Device Adverse Events ........................................................................................... 23 
B. Subject Adverse Event ............................................................................................ 23 
IX. Statistical Procedures .................................................................................................... 24 
A. General Information ................................................................................................ 24 
B. Statistical Analysis Description .............................................................................. 24 
1. Reproducibility ................................................................................................. 25 
2. Clinical Specimens ............................................................................................ 26 
X. 
Conduct of the Study ..................................................................................................... 30 
A. Responsibilities for Conduct of the Study .............................................................. 30 
B. Withdrawal from the Study ..................................................................................... 31 
C. Protocol Amendments ............................................................................................. 31 
D. Protocol Deviations ................................................................................................. 31 
E. Incident Reports ...................................................................................................... 31 
F. Discontinuation of the Study ................................................................................... 32 
G. Site File/Record Storage ......................................................................................... 32 
H. Site Data .................................................................................................................. 32 
I. Correspondence ....................................................................................................... 32 
XI. References ..................................................................................................................... 32 
XII. Investigator’s Agreement .............................................................................................. 33 
 
 
 
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Protocol No. 9DY-02-14U01-03 
 
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I. Introduction 
 
This protocol is for the evaluation of the Alinity s investigational assays using the 
Alinity s System. The Alinity s System is a high-volume, automated, blood-screening 
analyzer that is designed to determine the presence of specific antigens and antibodies 
by using chemiluminescent microparticle immunoassay (CMIA) detection technology. 
The system performs high-throughput routine and stat processing that features 
continuous access and automated retesting. The Alinity s System may also be referred 
to as BSQ. Some materials (e.g., calibrators, assay controls, reagents, bulk solutions) 
received may be labeled as BSQ instead of Alinity s. This material is considered 
equivalent and operates the same as Alinity s labeled material. 
 
The Alinity s System is used for infectious disease marker testing in blood-
screening and plasma laboratories for the following assays: 
• The Anti-HBc assay is used for the qualitative detection of antibody to hepatitis B 
core antigen (anti-HBc) in human serum and plasma. 
 
• The Anti-HCV assay is used for the qualitative detection of antibodies to hepatitis C 
virus (anti-HCV) in human serum and plasma. 
 
• The HTLV I/II assay is used for the qualitative detection of antibodies to human T- 
lymphotropic virus type I and/or human T-lymphotropic virus type II (anti-HTLV- 
I/anti-HTLV-II) in human serum and plasma. 
 
• The Chagas assay is used for the qualitative detection of antibodies to Trypanosoma 
cruzi (the causative agent of Chagas disease) in human serum and plasma. 
 
• The HBsAg assay is used for the qualitative detection of hepatitis B surface antigen 
(HBsAg) in human serum and plasma. 
 
• The HBsAg Confirmatory assay is used to confirm the presence of hepatitis B 
surface antigen (HBsAg) in human serum and plasma by means of specific antibody 
neutralization. 
 
• The HIV Ag/Ab Combo assay is used for the simultaneous qualitative detection of 
human immunodeficiency virus (HIV) p24 antigen and antibodies to HIV type 1 
(HIV-1 group M and group O) and/or type 2 (HIV-2) in human serum and plasma. 
 
The performance of the Alinity s blood screening assays will be evaluated by 
performing system reproducibility and specimen testing as described in the Testing 
Procedure section of this protocol. 
 
The Abbott monitor will provide assay clinical brochures for each of the assays which 
contain relevant referenced literature, applicable technology, and summary of any 
known and potential risks and benefits to humans. Alinity s clinical brochures will be 
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Protocol No. 9DY-02-14U01-03 
 
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provided for the Alinity s calibrators, the Alinity s assay controls, and the Alinity s 
release controls. 
 
This study will be conducted in compliance with this protocol, Good Clinical Practice 
(GCP) and the applicable regulatory requirements. 
 
II. Objectives 
 
The objective of this study is to demonstrate the performance and intended use of each 
of the Alinity s investigational assays in a donor screening environment using clinical 
samples to evaluate assay performance characteristics. A comparison of assay 
performance will be done versus the Food and Drug Administration (FDA) licensed 
assays. The data will be used to support regulatory submissions and/or publications. 
 
III. Study Design 
 
A. Overview 
 
Protocol directed testing will be performed at a minimum of 3 testing sites, to 
evaluate system reproducibility, specificity and sensitivity. For specificity, one of 
the sites that test specimens from whole blood donor collections will also test 
specimens from plasmapheresis collections. Specimens will be provided by 
clinical sites or by Abbott. In addition, panels will be provided by Abbott. A 
minimum of 3 lots of each of the Alinity s investigational assay reagents, 
calibrators and controls will be used throughout the study. 
 
The testing or collection sites will provide random donor specimens that are 
collected as part of the routine blood or plasma donation process to evaluate 
specificity of each assay. A minimum of 15,000 random donor specimens are 
needed for the Anti-HCV, HBsAg and HIV Ag/Ab Combo assays collected across 
a minimum of three whole blood donor centers and one plasmapheresis center. A 
minimum of 15,000 random donor specimens are needed for the Anti-HBc, HTLV 
I/II and Chagas assays collected across a minimum of three whole blood donor 
centers. Each donor specimen may be tested on one or more assays, therefore 
specimens may be obtained from approximately 23,000 to 90,000 blood donors 
depending on the number of assays tested on each donor sample. At the time of the 
blood donation, the donor will be informed that the donor center may use their 
donation for research studies. Donors will be provided an information sheet 
explaining this process. The donor may also be asked to return and participate in a 
follow-up blood collection based on results obtained. The donor will sign a 
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Protocol No. 9DY-02-14U01-03 
 
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separate research consent form for the follow-up blood collection and have 
approximately 20 to 60 mLs of blood drawn for testing. 
 
Abbott will provide frozen samples characterized as positive or at risk for 
infectious disease to evaluate sensitivity of each assay. The specimens will be 
designated by the Abbott monitor for each specific assay study. All specimens will 
be identified using a sample identification number (SID). 
 
1. System Reproducibility 
 
Abbott will provide reproducibility panel members for each assay that will be 
randomized during testing. System reproducibility will be performed in two 
runs per day on each of 5 (nonconsecutive) days with a minimum of one break 
of 1 day with a minimum of 3 lots of each Alinity s blood screening assay 
reagents, calibrators, and controls at a minimum of 3 sites. 
 
2. Specimen Testing 
 
To evaluate sensitivity for each of the Alinity s blood screening assays, Abbott 
will provide specimens that were prospectively collected under separate 
protocols or are not individually identifiable. These specimens include the 
following populations: 
• Preselected positives (all assays) 
• U.S. individuals at increased risk of disease (all assays, except Chagas) 
• Individuals from endemic areas (Chagas, HIV Ag/Ab Combo, and 
HTLV-I/II) 
 
To evaluate specificity for the Alinity s blood screening assays, the sites will 
provide residual serum or plasma from routine donations from the following; 
• Whole blood donors (EDTA plasma or serum for each of the Alinity s blood 
screening assays) 
• Plasmapheresis donors (Source Plasma for HIV Ag/Ab Combo, HBsAg & Anti-
HCV assays) 
 
3. Additional System Testing 
 
In addition, testing on the Alinity s System may be performed to align with the 
clinical site’s specific procedure(s) for the validation of a new system. Any 
associated analyses for this testing will be reviewed/ performed by Abbott and 
a data package will be provided to the clinical sites and maintained in the site 
study file. 
 
 
 
 
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Protocol No. 9DY-02-14U01-03 
 
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B. Ethics 
 
The protocol will be reviewed by the Institutional Review Board (IRB) as part of 
study oversight. 
The blood or plasma donor specimens will be collected as part of the routine 
blood donation process. The blood donor will review an IRB-approved 
information sheet as part of the consent process. The information sheet indicates 
that by consenting to donate blood or plasma their sample may be used in 
research studies. 
 
For the blood donor testing, if results of the investigational assay do not agree 
with the final specimen status based on supplemental testing, the donor may be 
asked to provide a follow-up sample. For these individuals providing follow-up 
samples, their consent to participate must be documented on an IRB-approved 
consent form prior to the collection of the follow-up specimen. 
 
The specimens provided by Abbott were either obtained prospectively and are 
considered linked or are not individually identifiable. The specimens will be 
identified by sample identification number, and the testing sites will have no 
access to subject data. Refer to the Section VI.A.1 Study Population/Sample Size 
for the specimen categories for each group. 
 
The specimens obtained prospectively were collected using IRB/IEC approved 
specimen collection protocols and consent forms that comprehend the testing of 
these specimens as outlined in this testing protocol. These specimen collection 
studies were either sponsored by Abbott or by specimen collection vendors. 
Specimens that are leftover, not individually identifiable were obtained according 
to the FDA Guidance on Informed Consent for In Vitro Diagnostic Device 
Studies using Leftover Human Specimens that are not Individually Identifiable, 
April 25, 2006 or specimens were obtained according to applicable laws and 
guidance regarding informed consent and the use of leftover human specimens. 
The unidentified specimens are being used when the scientific value is based on 
characterization of the sample rather than the subject’s medical history. 
 
These specimens will be identified by sample identification number, and the 
testing sites will have no access to subject data. The clinical testing sites will be 
blinded from knowledge of the specimen categories for specimens provided by 
Abbott. 
 
Donor specimens may be used to assess system performance. Specimens used for 
this assessment will be leftover residual samples that have been de-identified and 
cannot be linked to a subject. These specimens will be re-labeled with a new study 
identification number (SID). 
 
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Protocol No. 9DY-02-14U01-03 
 
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All reports transferred to and communications with Abbott which pertain to 
specimens in the study must identify each specimen by a sample identification 
number to ensure subject confidentiality. 
 
C. General Schedule of Events 
 
Each site will configure and calibrate the Alinity s blood screening assays on the 
Alinity s System. 
 
Prior to the start of protocol directed testing, the study staff will be trained in the 
operation of the Alinity s System. This training may occur at an Abbott facility or 
at the clinical site. The training will involve an overview of the system operation 
including system configuration, system maintenance, system calibration, control 
and specimen testing procedures. If needed, the clinical sites may supply leftover 
de-identified residual samples for the purpose of training or to confirm Alinity s 
System readiness. Documentation of study staff training will be maintained in the 
clinical study files. 
 
Testing personnel will be required to demonstrate acceptable performance with 
each investigational assay prior to beginning system reproducibility or specimen 
testing for that assay. The Abbott monitor will provide the samples for this testing. 
This testing is used for training and to confirm the site’s ability to perform the 
assay. 
 
After successful completion of training, testing personnel will perform 
reproducibility and specimen testing using the Alinity s blood screening assay, 
calibrator and assay control clinical brochures and the procedures as described in 
this protocol. 
 
Case report forms (CRF) will be utilized to document completion of the test 
procedures. The Abbott monitor will review the data and CRF to assure 
compliance to the study-directed procedures and to monitor the progress of the 
study. 
 
The study will take approximately 5-10 months to complete. 
 
D. Comparator Method 
 
Each donor specimen and each specimen provided by Abbott will be tested with a 
designated FDA-licensed assay using the ABBOTT PRISM system, with the 
exception of specimens that are well characterized or have limited sample volume.  
This includes the following: 
• HIV-1 Antigen positive - characterized by HIV-1 p24 testing. 
• HIV-1 viral isolate - characterized by PCR amplification, DNA sequence, and 
phylogenetic analysis. 
• Preselected T cruzi Parasite Positive - characterized parasite positive by 
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Protocol No. 9DY-02-14U01-03 
 
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xenodiagnosis, hemoculture, or blood smear. 
• Subset of preselected T cruzi serology positive and Chagas endemic 
specimens with limited sample volume that have comparator and 
supplemental testing data from a previous clinical study.  If any 
discrepant ABBOTT PRISM Chagas results occurs between new results 
and the previous clinical study results, all of the archived specimens in 
these 2 categories will be tested with the ABBOTT PRISM Chagas 
assay. 
The Abbott monitor will provide specific details of which specimens do not require 
comparator testing. All comparator testing will be performed according to the 
manufacturer’s instructions and will include retesting, where required. 
 
The comparator assay results will be compared to the corresponding results of the 
investigational assay. 
 
E. Supplemental Testing 
 
HIV, HBV and HCV nucleic acid testing (NAT) results for each of the donor 
specimens will be provided to Abbott to further characterize the donor specimens. 
 
Specimens from donors, individuals at increased risk, individuals from endemic 
areas, Recovered HBV Individuals (for HBsAg assay) and individuals with HTLV-
I/II associated diseases that are repeatedly reactive by either the Alinity s 
investigational assay or the comparator method or repeatedly gray zone negative (≥ 
0.80 S/CO to < 1.00 S/CO) by the Alinity s investigational assay will be further 
tested using FDA licensed assays or research use only methods. This supplemental 
testing will be performed at the clinical sites or at external reference laboratories. 
Results obtained from this testing will be used to better characterize the specimen 
and assess final status. 
 
The detailed algorithms for supplemental testing will be provided in a separate 
document for use with the clinical study protocol. Supplemental testing will be 
performed per each assay algorithm and if a specific assay is no longer 
commercially available or changes occur in the donor center’s routine procedure, a 
revised version of the algorithm will be provided by the clinical monitor. 
Additional testing may be performed based on the clinical site’s internal 
supplemental testing procedures. Data generated will be provided to Abbott and 
will be used for informational purposes. 
 
Preselected positive specimens for each assay will have documented positive 
results prior to testing at the clinical sites. Supplemental testing is not required, 
but may be requested by the monitor for troubleshooting purposes. 
 
 
 
 
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Protocol No. 9DY-02-14U01-03 
 
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F. Follow-up Specimens 
 
For all donor specimens with investigational Alinity s results that are discordant 
with final statuafter supplemental testing, an attempt will be made to obtain a 
follow-up whole blood specimen approximately 4 to 6 weeks after initial donation 
for further analysis. The subject will sign a study specific consent form for 
collection of the additional specimen. The follow-up specimen will be tested by the 
applicable investigational Alinity s blood screening assay, the comparator method, 
and supplemental testing as required. 
 
When a follow-up specimen is not obtained or to obtain additional information 
when an investigational Alinity s result is discordant with final status, an 
independent sample from the index donation (e.g., plasma unit) may be tested. 
Testing on the independent sample may include the investigational Alinity s blood 
screening assay, the comparator method, and supplemental testing as required. 
The follow-up result will be used to better characterize the initial donation and 
may be used to indicate seroconversion (or rule out seroconversion).  If 
seroconversion occurs and the follow-up results are repeatedly reactive for 
PRISM and positive on supplemental testing, the status for that donor will be 
considered positive and the index sample results will be removed from the 
specificity calculation. 
IV. Operating Conditions 
 
A. Material and Equipment 
 
1. Product Description 
 
All investigational products, supplies, and materials will be supplied by Abbott 
Laboratories. 
 
The investigational products include reagents, calibrators, assay controls, and 
release controls for each assay, and the consumables and commodities as 
follows: 
 
Alinity s HIV Ag/Ab Combo 
8100/6P01 
Alinity s HBsAg 
8100/6P02 
Alinity s HBsAg Confirmatory 
8100/6P03 
Alinity s Anti-HCV 
8100/6P04 
Alinity s Anti-HBc 
8100/6P06 
Alinity s HTLV-I/II 
8100/6P07 
Alinity s Chagas 
8100/6P08 
Alinity s Consumables/Commodities 
* Alinity Trigger 
8100/6P11-60 
* Alinity Pre-Trigger 
8100/6P12-65 
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Protocol No. 9DY-02-14U01-03 
 
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* 
Alinity s Concentrated Wash 
Buffer 
8100/6P13-88 
* Alinity Reaction Vessels 
8100/ 6P14-01 
* Alinity s Sample Cups 
8100/ 3R01-01 
 
Additional materials provided by Abbott: 
• Training panel 
• Reproducibility panel 
 
A description of the reagents, controls, accessories, consumables, and 
disposables required to operate the Alinity s System is presented in each of the 
assay specific clinical brochures. A further description of calibration and 
control procedures is presented in the Calibrator Clinical Brochure and Assay 
Control Clinical Brochure. 
 
Expired material(s) must not be used. 
 
All materials for the operation of the comparator device must be used within 
the expiration dates defined by the manufacturer’s instructions. 
 
2. Product Storage and Handling Requirements 
 
Storage instructions for the investigational reagents, calibrators, and controls 
are provided in the clinical brochure. Secured storage of these supplies with 
appropriately restricted access is required. 
 
The Alinity s accessories, consumables, and disposables must be stored as 
indicated on the product label or packaging. 
 
Abbott Laboratories will provide the sites with training panels and 
reproducibility panels. The panels will be shipped frozen and must remain 
frozen at -20°C or below upon receipt. Refer to the “Specimen Collection and 
Preparation for Analysis” section of the clinical brochure for storage and 
handling requirements. 
 
All commercially available products will be handled according to the 
manufacturer’s package insert instructions. 
 
3. Instructions for Use 
 
Testing on the Alinity s System for this study will utilize current version of 
system software. The site will operate the Alinity s System following 
investigational labelling instructions in the investigational Alinity s System 
Operations Manual and the clinical protocol. 
Instructions for use can also be found in the Alinity s blood screening assay, 
Calibrator, and Assay Control Clinical Brochures. 
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All versions of the clinical brochures used and a copy of the comparator 
method package inserts used in this study will be retained in the clinical study 
files. 
 
B. Environment 
 
Testing of the Alinity s blood screening assays will be performed at a minimum 
of 3 external donor testing facilities that will test whole blood donor collections. 
One of the sites that test specimens from whole blood donor collections will also 
test specimens from plasmapheresis collections.   
 
 
C. Testing Personnel Requirements 
 
Personnel involved in executing the study must be trained on operating and 
maintaining the Alinity s System. Each individual will also be trained on the 
protocol and clinical brochures and will be required to demonstrate acceptable 
performance with the investigational assay prior to beginning Testing Procedures 
described in this protocol. 
 
V. Product Accountability 
 
The testing site must maintain records and accountability documentation of the receipt 
dates, lot numbers, quantities, and the use, destruction and/or return of all 
investigational products. The Abbott monitor will periodically verify the accuracy of 
these inventories. 
 
All investigational products must be returned to Abbott or disposed of on-site. An 
investigator will not supply investigational products to any individual who is not 
named as a study investigator. 
 
VI. Study Methods and Procedures 
 
A. Specimen Selection 
 
1. Study Population/Sample Size 
 
Approximately 7,600 specimens provided by Abbott will be distributed across 
a minimum of 3 clinical sites for the testing with the designated Alinity s blood 
screening assay. Each site will test approximately 2,500 specimens representing 
similar distribution across assay and specimen categories on the designated 
Alinity s blood screening assay. Comparator testing will be performed at a 
minimum of one clinical site. 
 
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Assay 
Number 
Prospectively 
Collected 
Linked 
Not 
Individually 
Identifiable 
Alinity s HIV Ag/Ab Combo 
* Individuals at Increased Risk of 
HIV-1/2 Infection 
600 
X 
X 
* Individuals at Increased Risk of 
HIV Infection from an HIV-2 
Endemic Area 
500 
X 
* Preselected HIV-1 Positive 
1000 
X 
* Preselected HIV-2 Positive 
200 
X 
* Preselected HIV-1 Antigen 
Positive/ viral isolates 
50 
X 
Alinity s HTLV I/II 
* Individuals at Increased Risk of 
HTLV I/II Infection 
500 
X 
X 
* Individuals from an HTLV I/II 
Endemic Areas 
500 
X 
* Preselected HTLV I/II Positive 
600 
X 
X 
* Individuals with HTLV I/II 
Associated Diseases 
100 
X 
Alinity s HBsAg/HBsAg Confirmatory 
* Individuals at Increased Risk of 
HBV Infection 
400 
X 
X 
* Preselected HBsAg Positive 
400 
X 
X 
* Recovered HBV 
50 
X 
X 
Alinity s Anti-HBc 
* Individuals at Increased Risk of 
HBV Infection 
400 
X 
X 
* Preselected Total Anti-HBc 
Positive 
400 
X 
X 
Alinity s Anti-HCV 
* Individuals at Increased Risk of 
HCV Infection 
400 
X 
X 
* Preselected Anti-HCV Positive 
400 
X 
X 
Alinity s Chagas 
* Individuals from Chagas Endemic 
Areas 
600 
X 
* Preselected T cruzi Parasite 
Positive 
100 
X 
* Preselected T cruzi Serology 
Positive 
200 
X 
X 
Demographic information including age, gender, and race are documented, 
where available. Risk factors, medical history, and supplemental results are 
documented, as applicable. 
 
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2. Whole Blood Donor and Plasmapheresis Specimens 
 
Plasma or serum specimens from unique blood donors and plasma specimens 
from unique plasmapheresis donors will be obtained. 
 
Leftover specimens with sufficient residual volume of either plasma or serum 
specimen will be tested on each Alinity s blood screening assays as shown in 
the following table. 
 
Assay 
Whole Blood Donor 
(serum or EDTA 
plasma)* 
Plasmapheresis Donor 
(source plasma) 
HIV Ag/Ab Combo 
HBsAg/Confirmatory 
Anti-HCV 
12,000 
3,000 
HTLV I/II 
Anti-HBc 
Chagas 
15,000 
NA 
*At least one third of total whole blood donors will be EDTA plasma specimens 
and at least one third will be serum specimens. 
 
No demographic information will be collected from these blood donors. 
 
 
Inclusion and Exclusion Criteria 
Random donor specimens selected for the study must have sufficient volume to 
complete designated testing. The Abbott monitor will provide the 
recommended volume requirements for each assay. 
 
The subject/specimen must meet the following inclusion/exclusion criteria to 
be eligible for participation in this study: 
 
Inclusion Criteria 
 
Serum or EDTA plasma from a whole blood donor for each of the Alinity s 
assays or a plasmapheresis sample from a plasmapheresis donor (for HIV 
Ag/Ab Combo, HBsAg & Anti-HCV assays). 
 
Exclusion Criteria 
 
For testing with the Alinity s Chagas assay, exclude donors that have been 
screened on a previous donation using a licensed test for antibodies to T cruzi. 
 
Note: A subject may participate at different times during the study for separate 
assay studies, but each subject should be represented only once for each assay. 
 
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Frozen samples provided by Abbott have no specific inclusion/exclusion 
criteria that the clinical site needs to verify prior to testing. 
 
3. 
Specimen Handling, Storage, and Accountability 
 
Donor specimens will be handled according to the facility’s policies and 
procedures for collecting and storing specimen. 
 
Specimens obtained from whole blood donations at the clinical site are residual 
or left-over collected in either serum or EDTA collection tube. Specimens 
obtained from plasmapheresis donations are representative of the citrated 
plasma from the donation. Each specimen is to be tested using the unique blood 
donation identification number. 
 
Follow-up specimens from donors will be collected via routine venipuncture 
into EDTA and/or serum tubes according to the site’s routine collection 
procedures. Whole blood volume will be approximately 20 to 60 mLs. 
Specimen centrifugation will be done following the requirements of the 
comparator assay package insert and the requirements of the investigational 
Alinity s clinical brochure. After testing of the investigational assay and 
comparator assay, the remaining volume should be stored frozen at -20ºC or 
colder. Your Abbott monitor will provide details of any supplemental testing 
needed. 
 
Frozen specimens will be shipped to the site and must be stored frozen at -20°C 
or below, until tested. All frozen aliquots must be handled and stored at the 
clinical sites as described in the clinical brochure. Testing with the 
investigational assay will be performed using specimens subjected to the same 
number of freeze/thaw cycles (one thaw cycle). The comparator method testing 
should be done on the same freeze/thaw cycle (one thaw cycle). Sample 
aliquots used for testing on the comparator method should be handled or 
processed per the comparator method package insert. If a specimen is thawed 
and refrozen prior to testing or retesting, the occurrence must be documented 
on an Incident CRF and the Abbott monitor notified. 
 
The clinical testing sites must maintain records (e.g., packing slips) of the 
delivery and receipt of each shipment, as well as document the condition of the 
clinical specimens upon arrival and the location where the specimens are being 
stored. Specimen accountability documentation must be maintained by the 
testing site to document the use and destruction and/or return of specimens used 
in the study. 
 
Specimens should be shipped to Abbott Laboratories for additional testing or to 
a reference laboratory for supplemental testing as directed by the Abbott 
monitor. Store the specimens at -20 ºC or below and ship overnight on dry ice. 
When shipped, specimens must be packaged and labeled in compliance with 
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applicable state, federal, and international regulations governing the transport 
of clinical specimens and infectious substances. 
 
A specimen may be removed from the study if the sample is found 
unacceptable for testing (e.g. inappropriate handling prior to testing, inadequate 
volume), or for other assignable causes. The reason for removal must be 
documented on an Incident CRF. Specimens removed from the study may need 
to be replaced, if deemed necessary by the Abbott monitor, to meet 
requirements for the minimum number of specimens. 
 
B. General Study Procedures 
 
1. Assay and/or System Configuration 
 
The investigational Alinity s software is installed onto the Alinity s System at 
the time of instrument installation. The monitor will provide instructions on 
software configurations needed to start the study. 
 
2. Instrument System General Procedures 
 
Maintenance procedures are to be performed as instructed in the Investigational 
Alinity s System Operations Manual. Reports for maintenance and any 
documentation for component replacements that occurred during the study 
should be filed in study records. 
 
The on-board inventory of the Alinity s System supplies and reagents will be 
checked daily. Load consumables and update inventory as necessary. 
Refer to the Investigational Alinity s System Operations Manual. 
 
3. Assay Calibration 
 
Each Alinity s blood screening assay will be calibrated as described in the 
Alinity s Assay Clinical Brochure and the Alinity s Calibrator Clinical 
Brochure. The calibrator lot number and expiration date information will be 
read from barcodes when the material is tested on the instrument system. Refer 
to Calibration Procedures Section of the Alinity s System Operations Manual. 
 
Calibration is to be performed for each investigational reagent lot. Print or 
transfer electronic report of the calibration and control results for each reagent 
lot tested. Refer to the Alinity s Assay Clinical Brochure and Alinity s 
Calibrator Clinical Brochure for frequency of calibration. 
 
Refer to the Alinity s Assay Control Clinical Brochure to determine 
acceptability of the quality control results used during calibration. If 
unexpected results are obtained or problems are encountered, contact the 
Abbott monitor. 
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4. Assay Training 
 
The study staff will be trained in the operation of the Alinity s System prior to 
performing protocol directed activities. This training will involve an overview 
of the system operation including system configuration, system maintenance, 
system calibration, control and specimen testing procedures. 
 
Training materials (e.g., training panel) will be used to assess proficiency of the 
user performing the investigational assays. Assay training is to be performed by 
each user for each assay. Testing will be performed as described in a separate 
workflow document. The Abbott monitor will evaluate the results for 
acceptability. 
 
5. Quality Control Validity Criteria 
 
Daily quality control for each Alinity s blood screening assay will include all 
Alinity s assay controls tested a minimum of once each day, on each reagent lot 
tested for that day. 
 
Refer to the Investigational Alinity s System Operations Manual for testing of 
the quality controls. 
 
Daily quality control for each Alinity s blood screening assay will be assessed 
for validity using the ranges described in the Alinity s assay control clinical 
brochure. 
 
6. Troubleshooting Quality Controls 
 
The following steps must be used when troubleshooting and documenting 
quality control failures. 
 
1) Determine if an assignable cause can be found (e.g., incorrect placement, 
bubbles). If an assignable cause can be found, correct the identified problem. 
 
2) Retest the quality control from the original control bottle. If the quality 
controls are within the validity criteria, testing may continue. 
 
3) If the quality control value still does not meet the validity criteria, test the 
quality control substituting a new control bottle. If the quality control value is 
within the established range, continue testing. 
 
4) If the quality control value still does not meet the validity criteria, repeat assay 
calibration on the instrument and repeat all quality controls. If the quality 
control values are within the established range, continue testing. 
 
5) If the quality control value still does not meet the validity criteria, place new 
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reagents on the instrument, repeat assay calibration, and repeat all quality 
control testing. If the controls are within the validity criteria, testing may 
continue. 
 
Do not discard any reagents, calibrators, or controls that may have 
caused the out of range results. 
 
6) If the quality control value still does not meet the validity criteria, contact the 
Abbott monitor for further instruction. Any test results generated since the last 
acceptable control run must be evaluated to determine if test results may have 
been adversely affected. 
 
An Incident CRF must be completed, documenting the troubleshooting steps 
performed and any additional action required for resolution (e.g., recalibration, 
opening a new control bottle). The Abbott monitor must be notified when 
control failures are observed. 
 
7. Method for Handling Retests and Error Codes 
 
The following conditions may require retesting: 
 
• Specimens with S/CO values ≥ 1.00 are considered initially reactive for all 
Alinity s and comparator assays. Specimens with S/CO values from 0.80 to 
< 1.00 are considered initially gray zone negative for all Alinity s assays. 
Initially reactive and initially gray zone negative specimens must be 
retested in duplicate. 
• Testing of a specimen may be repeated if assignable cause (e.g., operator 
error, instrument malfunction) can be determined and documented by the 
site. 
 
• For tests that cannot be completed and result in an error code, the test is to 
be repeated. If unable to retest the specimen or additional troubleshooting 
steps are required to resolve the error, an Incident CRF should be completed. 
A copy of the error report or screen display should be printed or 
electronically transferred, when possible. 
 
The original SID will be used for all repeat testing. Refer to the Specimen 
Collection and Preparation for Analysis Section of the Alinity s Assay Clinical 
Brochure. If re-centrifugation is required, document on the appropriate CRF. 
 
8. Additional Troubleshooting 
 
The Abbott monitor may request certain procedures or additional testing to 
be performed for troubleshooting purposes. The additional testing may 
require various procedures be repeated. 
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C. Testing Procedures 
 
All clinical laboratory site testing is to be performed according to the clinical 
protocol and the appropriate sections of the clinical brochures. 
 
1. System Reproducibility 
 
Alinity s System reproducibility testing will be performed at a minimum of 3 
clinical sites using a minimum of 3 lots of each Alinity s blood screening assay 
reagents, calibrators, and controls. 
 
Testing will include two runs per day on each of 5 (nonconsecutive) days with 
a minimum of one break of 1 day with a minimum of 3 Alinity s reagent lots at 
a minimum of 3 sites. Each reproducibility run will include four replicates 
tested for each reproducibility panel member. 
 
Procedure 
 
1) Test each Alinity s blood screening assay control (Negative and Positive 
plus any additional controls required for HIV or HTLV testing), if daily 
quality controls have not been already tested and assessed for validity. 
 
2) Refer to the “Specimen Collection and Preparation for Analysis” section of 
the assay clinical brochure for detailed procedures on handling of samples 
prior to placing the reproducibility panel members on the Alinity s System. 
 
3) Place the barcoded sample tubes in a sample rack as directed by the Abbott 
monitor. 
 
4) Schedule an Alinity s release control for each assay. If release control is not 
already on the system, place the calibrator and control rack on the Alinity s 
System in the priority bay to schedule testing. 
 
5) Testing as described in Steps 1 through 4 will be performed on each of five 
days for each reagent lot for each assay. 
 
Note: If an error occurs during reproducibility testing, contact the Abbott 
monitor. The reproducibility testing for that day may need to be repeated. 
Errors which occur during reproducibility testing should be documented on 
an Incident CRF. 
 
2. Specimen Testing 
 
Testing will be performed to determine the agreement of specimen results 
obtained from each Alinity s blood screening assay to the comparator method. 
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Testing of the comparator method will be performed according to each 
comparator package insert. 
 
Each of the donor collection sites will provide specimens from random donors 
representing unique individuals for a total of 15,000 donor specimens for each 
assay. Whole blood donor specimens will be provided by a minimum of three 
donor collection sites and one site will provide specimens from plasmapheresis 
donors for HBsAg, anti-HCV, and HIV Ag/Ab Combo assays. Each testing site 
will test a portion of the whole blood donor specimens with a distribution of 
testing across a minimum of three Alinity s reagent, calibrator, and control lots 
as instructed by the monitor. The testing sites for Alinity s and PRISM may be 
different. The testing of the plasmapheresis specimens will be distributed 
across three Alinity s reagent, calibrator, and control lots. The results for the 
corresponding PRISM comparator assay and NAT assay, as applicable will be 
provided to Abbott for each donor specimen. Testing of any follow-up donor 
specimens will be done using the procedure below for the investigational 
Alinity s assay, comparator assay and supplemental testing as needed. 
 
Approximately 7,600 specimens provided by Abbott will be distributed across 
the clinical testing sites. Specimens will be tested across a minimum of three 
lots of Alinity s assay reagents, calibrators and controls. Each site may test 
approximately 2,500 specimens depending on the total number of clinical sites 
and representing similar distribution across assay and specimen categories. In 
addition, the specimens will be tested on the corresponding PRISM comparator 
method at a minimum of one clinical site. The Abbott monitor will provide the 
details of which specimens to test for each assay, as well as the 
reagent/calibrator/control lot combination. 
 
Note: After testing of a specimen, any remaining specimen volume must be 
retained frozen. The Abbott monitor may request certain procedures or 
additional testing to be performed for troubleshooting purposes. The additional 
testing may require various procedures to be repeated. 
 
Note: Specimens should be tested on the same freeze thaw cycle for the Alinity 
s assay and the comparator method. If the sample has been tested or retested on 
a subsequent freeze thaw cycle, the event should be documented on an Incident 
Report form. 
 
Procedure 
 
1) Test each Alinity s assay quality control, if daily Alinity s quality controls have 
not been already tested and assessed for validity. 
 
2) Refer to the “Specimen Collection and Preparation for Analysis” section of the 
clinical brochure for detailed procedures on handling of samples prior to 
placing specimens on the Alinity s System. 
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3) A single replicate of each specimen should be tested with the investigational 
Alinity s assay. Specimens should be placed in barcoded tubes in a sample 
rack and placed on the Alinity s System to schedule testing. 
 
4) Schedule a Alinity s release control for each assay. If release control is not 
already on the system, place the calibrator and control rack on the Alinity s 
System in the priority bay to schedule testing. 
 
Note: All testing data generated before the release control will be 
printed when release control testing is complete. 
 
5) Specimens with an initial S/CO result of ≥ 1.00 are considered initially reactive. 
Specimens with an initial S/CO result ≥0.80 to <1.00 are considered initially 
gray zone negative. Both initially reactive and initially gray zone negative 
specimens should be retested in duplicate with the Alinity s method. Specimens 
with an initial S/CO results of < 0.80 are considered nonreactive and do not 
require further testing. 
 
6) Repeat testing should be performed using the same reagent lot and be done on 
the same day or the following workday. If greater than 48 hours has elapsed 
from initial centrifugation, re-centrifuge the sample and document on the 
Incident CRF. Refer to Alinity s assay clinical brochure for further information 
regarding centrifugation of specimens. 
 
7) If both duplicate retest results are nonreactive (S/CO < 0.80), then the 
specimen is considered negative and no further testing is required. If either 
retest result has S/CO ≥0.80, then supplemental testing for the assay will be 
performed. 
 
8) Each specimen should be tested with the comparator PRISM method. 
Specimens initially reactive by the comparator method should be retested in 
duplicate on the same day or on the next work day of testing. If re- 
centrifugation is required for the comparator method testing, document on the 
appropriate CRF. Refer to comparator package insert for further information 
regarding centrifugation of specimens. 
 
9) If the comparator method result is repeatedly reactive, then supplemental 
testing for the assay will be performed. 
 
10) Refer to the Alinity s Supplemental Algorithms and instructions from your 
Abbott monitor regarding supplemental testing. 
 
11) After supplemental testing is complete for donor specimens, the Abbott 
monitor will notify you/the collection site of any donors that need to be 
contacted for follow-up blood collections. 
 
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Note: For other situations where retesting may be required (e.g. error codes) 
refer to the “Method for Handling Retests and Error Codes” section of this 
protocol. 
 
VII. Methods for Data Collection and Documentation 
 
A. Instrument Data Capture 
 
In addition to the required instrument printouts, Alinity s data will be transmitted 
electronically using an approved data capture procedure (e.g., Abbott Link) by 
Abbott personnel on a daily or as needed basis. 
 
For Abbott PRISM comparator data, the data will be transmitted electronically to 
Abbott using an internet data capture method. Instrument report data (e.g., 
instrument printout or other approved format) for all PRISM testing related to this 
study will also need to be provided to Abbott. 
 
If any assay data is not retrieved by the electronic capture system, the data will be 
manually entered into the database at Abbott using the original instrument printout. 
 
B. Case Report Forms 
 
Case report forms (CRF) will be provided for collection of data including detailed 
instructions for completion of the CRFs. 
 
CRF data or information related to the study will be recorded electronically using a 
web based system. Site personnel responsible for entering data will be trained on 
the use of the electronic system (i.e., access, entry and submission of data). Data 
entered by the site will be reviewed by an Abbott monitor, and queried if needed. 
Queries should be resolved in a timely manner. 
 
Data or information recorded on the CRF with no prior written or electronic 
record, (e.g., specimen processing, storage date and time) will be considered the 
source document. 
 
The investigator must sign or certify the CRF where indicated. The investigator’s 
signature indicates that the data are accurate and complete. Where signatures are 
required they must be handwritten or captured electronically per 21 CFR Part 11. 
Stamps for signatures are not allowed. 
 
At the conclusion of the study, a copy of the completed CRF will be maintained 
at each investigational site. 
 
C. Supplemental Data Transfer 
 
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The HIV, HBV and HCV nucleic acid testing (NAT) results for the donor 
specimens will be provided to Abbott in a format as agreed upon with the clinical 
monitor. 
 
The results for supplemental testing will be entered or a copy of the results (e.g., 
instrument printout, worksheet, report) will be uploaded into the eCRF system by 
the site. 
 
VIII. Adverse Events 
 
No side effects or adverse events are anticipated. In the unexpected event of a serious 
adverse event resulting from use of the investigational device, the Abbott monitor must 
be notified immediately by telephone and subsequently in writing within five (5) days 
of the occurrence. The event must be described on the adverse event case report form, 
as applicable. All adverse events are to be followed to satisfactory resolution, and any 
measures taken, as well as the follow-up, reported on the appropriate CRF. 
 
A. Device Adverse Events 
 
A Device Adverse Event is any effect on the health or safety of an individual 
associated with the use of a product which has or may have caused or contributed 
to an injury, a system malfunction or user error resulting in personal injury (e.g., 
electrical shocks, burns), or exposure to potentially hazardous material (e.g., 
chemical or biohazardous), or a fire or visible smoke that was not self-contained to 
the system and caused damage outside of the system. 
 
A Device Serious Adverse Event is an adverse event that has or may have caused 
or contributed to a death or serious injury of an individual or an adverse event 
resulting from malfunction that could cause or contribute to a death or serious 
injury if the malfunction were to recur. A serious injury includes a life-threatening 
illness or injury, an illness or injury which results in permanent impairment of a 
body function or permanent, irreversible damage to body structure, or a condition, 
an injury or illness necessitating a medical or surgical intervention by a health care 
professional to prevent permanent, irreversible impairment of a body function, or 
damage to a body structure. 
 
B. Subject Adverse Event 
 
Donor specimens used in the study are collected as part of the routine blood 
donation process. Events related to the blood or plasma donation process will be 
handled according to the donor center procedures and not recorded in the study 
files. 
 
For donor follow-up specimens collected under this protocol, subject adverse 
events will be documented if they occur. It is expected that drawing blood or 
plasma may cause pain, bruising, lightheadedness, and on rare occasion, infection 
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at the site of the blood draw. These events will not be recorded as adverse events 
as they are considered to be normal events that may occur during the course of a 
blood or plasma draw. Other events that may occur such as fainting, that are not 
routinely associated with a blood or plasma draw, must be recorded on the Subject 
Adverse Event Case Report Form and be followed to satisfactory resolution. 
 
A Subject Adverse Event is any unfavorable or undesirable medical occurrence 
(e.g., sign, symptom, or disease) temporally associated with the specimen 
collection procedure performed. 
 
A Subject Serious Adverse Event is an untoward medical occurrence that: 
• results in death 
• is life-threatening 
• requires inpatient hospitalization or prolongation of existing hospitalization 
• results in persistent or significant disability/incapacity, or 
• results in a congenital anomaly/birth defect. 
 
IX. Statistical Procedures 
 
A. General Information 
 
All data analyses will be performed, and tables and listings of data will be 
provided by ADD Statistics using SAS version 9.2 or higher. 
 
If revised or additional analyses are required, a description of the additional or 
revised analyses and justifications for the changes will be documented and 
approved by the same functional areas as the original approvers to the protocol. 
 
The Abbott monitor will review all test results and may request that certain 
observations be excluded from analysis if there is an assignable cause, i.e., control 
or validity criteria failure, instrument errors or problems, acknowledged 
technologist error, and/or noncompliance with the study protocol. All results tested 
according to the protocol and not excluded will be eligible for analysis. 
 
The statistical analysis output along with a listing containing each observation 
collected for this study will be completed. The listing will be printed for data 
included in the analysis and excluded from the analysis. The excluded listing will 
include the reasons for exclusion. A summary of the usage of every test result will 
also be completed, together with the final analysis results, to ensure that there is no 
data point missing or misplaced in the analysis. 
 
There is no plan to perform interim analyses that evaluate interim data against 
acceptance criteria. However, interim data monitoring will be conducted to ensure 
data meets validity criteria and minimum sample size requirements. 
 
B. Statistical Analysis Description 
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1. Reproducibility 
 
a. Study Design 
 
Assay reproducibility will be determined by testing controls and members 
of a panel at a minimum of three sites with one instrument using a 
minimum of 3 lots of each Alinity s blood screening assay reagents, 
calibrators, and controls. 
 
b. Analysis Variables 
 
The analysis variable is Alinity s assay S/CO values for all panel members 
and controls. 
 
c. Statistical Analysis Method 
 
The analysis method is based on CLSI EP15-A2E. The reproducibility 
panel members and the Negative and Positive controls will be tested twice 
a day for a minimum of 5 days per reagent lot (minimum 3 lots) and site 
(minimum 3 sites). Within each run, each panel member/control will be 
tested in two aliquots and two replicates will be assayed per aliquot, 
resulting in four results per sample. 
 
Overall Analysis 
Data from all sites and reagent lots for each reproducibility panel/control 
member will be used for the reproducibility analysis. The following 
individual variance components will be estimated: within-run, between-run, 
between-day, between-lot, between-site, and lot-site interaction. The within-
laboratory variance is defined as the summation of within-run, between-run, 
and between- day variance components. The overall assay variability is 
defined as the summation of within-run, between-run, between-day, 
between-lot, between-site, and lot-site interaction variance components. The 
estimates of the mean S/CO, standard deviation (SD) and %CV will be 
calculated. 
By Site Analysis 
A similar analysis as overall analysis will be performed by site for each 
reproducibility panel/control member. The within-run, between-run, 
between- day, and between-lot variance components will be estimated. The 
within- laboratory variance is defined as the summation of within-run, 
between-run, and between-day variance components. 
By Lot Analysis 
A similar analysis as overall analysis will be performed by reagent lot for 
each reproducibility panel/control member. The within-run, between-run, 
between- day, and between-site variance components will be estimated. 
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The within- laboratory variance is defined as the summation of within-run, 
between-run, and between-day variance components. 
Percent Agreement 
A percent agreement and the 95% confidence interval with the expected 
results from a sample (reactive or nonreactive) will be performed for each 
panel/control. 
d. Sample Size 
 
The design of the study is based on CLSI EP15-A2E. Each reproducibility 
panel/control member (sample) will be tested twice a day for 5 days in 
replicates of 4 at a minimum of 3 sites, using a minimum of three (3) 
reagent lots to obtain about 360 replicates for each sample (i.e., 2 runs/day x 
5 days x 4 replicates x 3 sites x 3 lots = 360 total replicates). 
e. Level of Significance/Confidence Statement 
 
A 95% confidence interval will be constructed for agreement analysis. 
f. Data Handling Convention 
All results from this testing that are performed according to the protocol 
and not excluded will be eligible for analysis. Reasons for any exclusion 
will be captured in the database. 
 
g. Outlier Detection 
The range of data (difference between the maximum and minimum within a 
run) will be calculated by sample, site, lot, day, and run. If the range of the 
data is greater than 9 times the standard deviation (SD) using the applicable 
imprecision product requirement, investigate and identify the run as an 
outlier run and the run will be repeated for that panel/control. If the (5.5 × 
SD) < (range of the data) ≤ (9 × SD) from the applicable imprecision 
product requirement, investigate and identify the run as an outlier run but 
do not repeat the run for that panel/control. 
 
The reproducibility analyses will be performed with the outlier(s) included 
and with the outlier(s) excluded. 
 
2. Clinical Specimens 
 
Clinical specimens will be tested with the Alinity s blood screening assay, 
corresponding comparator method, and supplemental testing assays as needed 
to determine final status. 
 
a. Study Design 
 
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Percent agreement will be calculated between Alinity s blood screening 
assay results and corresponding comparator method results. Supplemental 
testing will be performed to determine specimen final status. The 
sensitivity and specificity will be calculated based on specimen final status. 
For each Alinity s and comparator assay, the specificity will be calculated 
using results from donor specimens, a presumed zero prevalence 
population and the sensitivity will be calculated using results from 
preselected positive populations and from endemic or increased risk 
populations. 
b. Analysis Variables 
 
• 
Alinity s blood screening assay interpretation and PRISM comparator assay 
interpretation 
• Specimen Category 
• Specimen final status according to Supplemental Testing algorithm. 
 
c. Statistical Analysis Method 
 
Percent Agreement 
Percent agreement of Alinity s blood screening assay final results and 
comparator assay final results will be calculated. 
 
 
Alinity s Assay 
Comparator Assay 
Repeatedly Reactive 
Nonreactive 
Repeatedly Reactive 
A 
B 
Nonreactive 
C 
D 
 
Percent Agreement = (A + D) / (A + B + C + D) × 100% 
 
Initial Reactive Rate and Repeat Reactive Rate 
The number and percentage of Alinity s blood screening Assay initially 
reactive donors, the number and percentage of Alinity s blood screening 
assay repeatedly reactive donors, and the number and percentage of 
repeatedly reactive donors that are positive by supplemental testing will be 
summarized. 
 
 
Two-sided 95% confidence intervals will be calculated for initial and repeat 
reactive rates using the exact method based on the binomial distributions. 
 
IR Rate not Reactive on Retest and RR Rate not Positive by 
Supplemental testing 
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The number and percentage of Alinity s blood screening assay initially 
reactive donors that are not reactive on retest and the number and 
percentage of repeatedly reactive donors that are not positive by 
supplemental testing will be summarized. 
 
Two-sided 95% confidence intervals will be calculated for IR Rate not 
Reactive on Retest and RR Rate not Positive by supplemental testing using 
the exact method based on the binomial distributions. 
 
The following table will be used to calculate assay specificity and 
sensitivity based on the specimen final status. 
 
Alinity s assay 
Final Status 
Positive 
Indeterminate 
(if applicable) 
Negative 
Repeatedly 
Reactive 
A 
B 
C 
Nonreactive 
D 
E 
F 
 
 
Specificity 
The calculation of specificity will include results from whole blood donors 
and plasmapheresis donors. Analyses described in this section will be 
performed for the combined donors, by specimen type, and by site. 
 
 
The specificity is calculated as the proportion of nonreactive (NR) specimens 
from specimens with negative status:  
  
Specificity = F / (C + F) × 100% 
Specificity can be also calculated as the proportion of nonreactive (NR) 
specimens with negative status from specimens with negative status and 
repeatedly reactive (RR) specimens with indeterminate status: 
 
Specificity = F / (C + B + F) × 100%  
Two-sided 95% confidence intervals will be calculated for specificity using 
the exact method based on the binomial distributions. 
 
For the combined donors and by specimen type, the specificity will be 
calculated for the comparator assay. 
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Histograms 
 
Population distributions for the donor specimens will be presented in 
histograms and will include mean S/CO values of the nonreactive 
population, the SD of the population, and the number of SDs from the 
mean to the cutoff. These histograms will be presented for the combined 
donor population by site, and by sample type. 
 
Sensitivity 
The evaluation of sensitivity will include results of the following specimens: 
preselected positive, individuals at increased risk of infection, and/or 
individuals from an endemic area at increased risk of infection. 
 
Sensitivity is calculated as the proportion of repeatedly reactive (RR) 
specimens from specimens with positive final status: 
 
Sensitivity = A / (A + D) × 100% 
 
Sensitivity can be also calculated as the proportion of repeatedly reactive (RR) 
specimens with positive status from specimens with positive status and 
nonreactive (NR) specimens with indeterminate status: 
  
Sensitivity = A / (A + D + E) × 100% 
 
A two-sided 95% confidence interval for overall sensitivity will be 
calculated using the exact method based on the binomial distributions. 
 
All sensitivity calculations described above will also be done for the 
comparator assay. 
 
d. Sample Size 
 
Sample size for specificity is maximum of 15,000 and calculated based on 
the minimum power of 80% and α ≤ 0.05. 
 
Sample size for sensitivity is not determined using statistical power 
calculations. Sample size is determined by the number of available 
specimens. 
 
e. Level of Significance/Confidence Statement 
 
Two-sided 95% confidence interval (CI) will be provided. 
 
 
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f. Data Handling Convention 
 
All results from this testing that are performed according to the protocol 
and not excluded will be eligible for analysis. Reasons for any exclusion 
will be captured in the database. 
 
X. Conduct of the Study 
 
A. Responsibilities for Conduct of the Study 
 
1) The investigator will have written and dated approval/favorable opinion from the 
[Institutional Review Board (IRB) or Independent Ethics Committee (IEC)] for 
the protocol and other documents as specified by the [IRB/IEC] before initiating 
the study. In some cases, the [IRB/IEC] may provide an expedited or exception 
review. 
 
2) The investigator is responsible for reporting to the [IRB/IEC] and obtaining the 
necessary approvals from his/her site administration. 
 
3) Abbott Laboratories will not initiate the study until the required pre-study 
documents are received from the site. Pre-study documents are aligned with GCP 
requirements and a detailed listing of the required pre-study documents will be 
provided to the investigator by the Abbott monitor. 
 
4) The investigator will perform the study in accordance with GCP. The Abbott 
monitor will provide the investigator with the GCP-aligned list of investigator 
requirements. 
 
5) The Abbott monitor will provide the investigator with the Guidance for Industry 
Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study 
Subjects (October 2009) for reference. 
 
6) Abbott Laboratories has a responsibility under GCP to monitor this clinical study. 
The Abbott monitor will provide the investigator with the GCP-aligned list of 
responsibilities of the Abbott monitor. 
 
7) The investigator will maintain a list of appropriately qualified persons to whom 
he/she has delegated significant study-related duties. This list must be updated as 
needed and the Abbott monitor must be notified of the changes. 
 
8) The investigator will assure that all subjects are provided both written and oral 
informed consents, and that the subject’s consent is documented in accordance 
with local laws. In addition, every subject will be provided a copy of the consent 
form. 
 
9) The investigator will maintain the subject’s original consent form in the subject’s 
permanent medical record or in the investigator’s records, depending on site 
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policy. 
 
10) The investigator agrees to the requirement for guaranteed access to source data 
and to the investigator himself/herself by the IRB, Abbott monitor(s), auditors, 
and regulatory inspectors for the purpose of data verification or correction. 
 
B. Withdrawal from the Study 
 
A subject’s participation in any clinical study is voluntary and the subject has the 
right to withdraw from the study anytime without prejudice, however, the request 
to withdraw agreement does not include information that has already been made 
known or information gathered as a result of participation in the study. All subjects 
enrolled must be accounted for and the withdrawal of any subjects from the study 
will be documented on the appropriate CRF. Individuals withdrawn from the study 
may be replaced with another individual that meets the subject enrollment criteria. 
 
C. Protocol Amendments 
 
All protocol amendments will be written and approved by Abbott Laboratories 
prior to its submission for IRB review and approval or exemption. 
 
The investigator will not implement or deviate from the protocol without 
agreement from Abbott Laboratories and prior review and approval from the 
IRB. Exceptions to this include instances where it is necessary to eliminate an 
immediate hazard to study subjects, or when the protocol changes involve only 
logistical or administrative aspects of the study. 
 
D. Protocol Deviations 
 
A protocol deviation is defined as a planned or unplanned departure from the study 
protocol. All protocol deviations that occur during this study will be recorded on 
the protocol deviation CRF. 
 
Planned deviations from this protocol must be reported to the monitor prior to 
implementation. The implemented deviation and the circumstances regarding the 
deviation will be documented on the protocol deviation CRF. The monitor will 
approve in writing the inclusion of any specimen, which does not meet all of the 
inclusion or exclusion criteria of the study. The monitor may provide verbal 
approval prior to the written response. 
 
E. Incident Reports 
 
An incident CRF will be used to document any incident(s) that occur during the 
clinical study. An incident is defined as any unplanned or unexpected event that 
occurs with or without the input or intervention of the operator. The Incident CRF 
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should include a description of the incident, possible cause (if known), action 
taken, and identify any specimens that were affected. 
 
F. Discontinuation of the Study 
 
The study may be terminated prior to the stated time for reasons of safety or 
efficacy, or for other identified causes. The reason for discontinuation will be 
documented in the clinical study master file. 
 
G. Site File/Record Storage 
 
The investigator should arrange for the retention of all study documents in the site 
file. The investigator shall retain the site file records for at least a period of 2 years 
following the date a marketing application is approved; or if no application is to be 
filed or if the application is not approved for such an indication, until at least 2 
years after the investigation is discontinued and the FDA is notified. These 
documents should be retained for a longer period, however, if required by the 
applicable regulatory requirements or by agreement with the sponsor. It is the 
responsibility of the sponsor to inform the investigator/institution when these 
documents no longer need to be retained. 
 
H. Site Data 
 
At the completion of the study a listing of the site’s data generated during the 
study will be provided to each site. 
 
I. Correspondence 
 
All correspondence between the Abbott monitor and the testing site must be 
documented and retained as part of the study records (i.e. any telephone 
communication with the Abbott monitor should be documented in a telephone 
log; copies of e-mail messages should be printed). 
 
XI. References 
 
Abbott PRISM Operations Manual 
 
CLSI. User Verification of Performance for Precision and Trueness; Approved Guideline 
– Second Edition, CLSI document EP15-A2E [ISBN 1-56238-574-7]. CLSI, 940 West 
Valley Road, Suite 1400, Wayne, Pennsylvania, 19087-1898, USA, Apr, 2006. 
 
CDRH guidance document. Guidance on Informed Consent for In Vitro Diagnostic 
Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, 
April 25, 2006. 
 
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XII. Investigator’s Agreement 
 
By signing this statement, the investigator agrees: 
 
1. I have read and understand the contents of the Alinity s Blood Screening Assays - 
Clinical Evaluation Protocol (Protocol No. 9DY-02-14U01-03, Version 5, dated April 
18, 2018) and appropriate clinical brochure(s) and will adhere to the study 
requirements as presented, and applicable local regulations. 
 
2. I will protect the rights, safety, and well-being of subjects. Before initiating the 
study and where required by local regulations, an Institutional Review Board 
(IRB) will review and approve the study protocol and all other applicable study 
material. A copy of the approval of the study protocol will be submitted to 
Abbott Laboratories. 
 
3. I will not use the results from products labeled as “For Investigational Use 
Only” or “For Performance Evaluation Only” for diagnostic purposes, because 
the performance characteristics of the product have not been established. 
 
4. I understand that Abbott Laboratories, its designees, and regulatory authorities 
may require access to source documents for verification of study data. 
 
5. I understand that if any questions arise, now or during the clinical evaluation, I 
will promptly contact the Abbott monitor or designee at Abbott Laboratories for 
clarification. 
 
Investigator (Printed Name): _____________________________________________ 
 
Investigator Title: ______________________________________________________ 
 
Investigator Signature: ____________________________________ Date: _________ 
 
Institution Name: _______________________________________________________ 
 
Institution Address: ______________________________________________________ 
                                                          
______________________________________________________ 
______________________________________________________ 
 
 
 
 
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                     Appendix 1: Scientific Amendment 
Amendment No: 4 
Summary of Changes 
The following change incorporated in Protocol No. 09DY-02-14U01-03, Version 5, dated April 
18, 2018 is referenced from Version 4, dated October 13, 2017. 
1. Change: Section III. C. Study Design, General Schedule of Events, change to “The 
study will take approximately 5-10 months to complete.”  
 
 
 
 
Detailed Description of Changes 
 
Change 1 (Scientific Change) 
• Change: Section III. C. Study Design, General Schedule of Events, change “The 
study will take approximately 5 months to complete.” to “The study will take 
approximately 5-10 months to complete.”  
 
• Reason: The change is made to ensure the duration of study reflects the actual 
duration.  
 
• Justification: Due to the change in strategy for execution of the protocol, the study 
duration is extended for sites remaining open for Chagas testing. A Protocol Impact 
Assessment form was completed to assess the impact of clinical study testing. There is 
no impact to the clinical study.  
 
 
 
End of Document 
 
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