Over the Counter Rapid Antigen Test for Detection of SARS-CoV-2 Virus: Human Usability Study
Phase: NA
Conditions: Sars-CoV-2 Infection, COVID-19
Sponsor: MP Biomedicals, LLC

 COVID-19 Rapid Ag Usability Study 
EDP Biotech Corporation Confidential 
 
 
 
 
 
 
Over the counter Rapid Antigen Test for detection of 
SARS-CoV-2 virus: Human Usability Study 
 
 
August 13, 2021 
 
 
 
Protocol Number:  
EDP-SOP-TNC-013 
 
 
 
Performed at: 
EDP Biotech Corporation 
6701 Baum Drive, Suite 110 
Knoxville, TN  37919 
 
 
 
Sponsored by: 
MP Biomedicals, LLC 
29525 Fountain Parkway 
Solon, OH  44139 
 
 
 
 
 
 
Rev. B 
 
 
 
 
 
 

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For Investigational Use Only. 
 The performance characteristics of this device  
have not been established  
Contents 
List of Tables ........................................................................................................................................... 3 
List of Appendices ................................................................................................................................... 3 
Study Personnel and Approvals ............................................................................................................... 4 
1.0 Introduction ........................................................................................................................................ 5 
1.1 Device Name (working name) ........................................................................................................ 5 
1.2 Intended Use ................................................................................................................................... 5 
1.3 Background ..................................................................................................................................... 5 
1.4 Principles of the Device .................................................................................................................. 5 
2.0 
Scientific Objectives ..................................................................................................................... 6 
2.1  
Study Rationale ......................................................................................................................... 6 
2.2 
Study Objectives ....................................................................................................................... 6 
3.0 
Study Materials………………………………………………………………………………….6 
3.1      Specimen Collection Materials/Equipment ............................................................................... 6 
3.2 
Computer Hardware and Software ............................................................................................ 7 
3.3 
Collection/Storage/Transfer of Data Files................................................................................. 7 
4.0 
Study Design ................................................................................................................................. 8 
4.1 
Site Characteristics .................................................................................................................... 8 
4.2 
Site Personnel ............................................................................................................................ 8 
4.3 
Specimen Collection ................................................................................................................. 8 
4.4 
Sample Types and Numbers ...................................................................................................... 9 
5.0 
Sample Preparation and Testing Procedure ................................................................................ 10 
5.1 
Instrument Set-Up (Calibration and Quality Control)............................................................. 10 
5.2 
Reagent Preparation ................................................................................................................ 10 
5.3 
Specimen Processing ............................................................................................................... 10 
5.4 
Sample Preparation ................................................................................................................. 10 
5.5 
Control/Calibrator Preparation ................................................................................................ 10 
5.7 
Reporting of Results ................................................................................................................ 11 
6.1 
Sample ID Numbers and Identification ................................................................................... 11 
6.2 
Data Evaluation and Accessibility .......................................................................................... 11 
6.2.1 
Acceptability of Data for Analysis .................................................................................. 11 
6.2.2 
Exclusion of Data from Analysis ..................................................................................... 11 
6.2.3 
Data Entry and Corrections to Study Documents ............................................................ 11 
6.2.4 
Assay Run Data................................................................................................................ 12 
6.2.5 
Invalid Results ................................................................................................................. 12 

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7.0 
Documentation ............................................................................................................................ 12 
7.1 
Data Reporting Forms and Tracking Log Sheets .................................................................... 12 
7.2 Tester and Subject Questionnaires ............................................................................................... 13 
7.3 Instrument-Generated Printouts .................................................................................................... 13 
8.0 
IRB Requirements ....................................................................................................................... 13 
8.1 
Informed Consent .................................................................................................................... 13 
8.2 
IRB Approval .......................................................................................................................... 14 
9.0 
Risk Analysis .............................................................................................................................. 14 
10.0 Study Master File (SMF) ............................................................................................................... 14 
10.1 Required Essential Documents ............................................................................................... 14 
11.0 Monitoring .................................................................................................................................. 15 
12.0 Investigational Study Site Compliance ....................................................................................... 15 
12.1 
Investigator Responsibility ...................................................................................................... 15 
12.2 
Site Monitoring and Inspection ............................................................................................... 15 
12.3 
Record Retention ..................................................................................................................... 15 
13.1 
Toxicity and Complications .................................................................................................... 15 
13.2 
Sample Handling ..................................................................................................................... 15 
14.0 Modifications to the Protocol...................................................................................................... 16 
14.1 
Protocol Amendments ............................................................................................................. 16 
14.2 
Study Termination ................................................................................................................... 16 
15.0 Abbreviations .............................................................................................................................. 16 
16. References ........................................................................................................................................ 17 
 
List of Tables 
 
Table 1- Rapid SARS-CoV-2 Antigen Test Materials……...……………………………….…………6 
 
 
List of Appendices 
 
Appendix 1 - EDP-SOP-TNC-003 Appendex 1 Rapid Ag IFU 
Appendix 2 - EDP-SOP-TNC-013 Appendex 2 Tester Information Form 
Appendix 3 - EDP-SOP-TNC-013 Appendex 3 Subject Information Form 
Appendix 4 - EDP-SOP-TNC-013 Appendex 4 SUS Form 
Appendix 5 - EDP-SOP-TNC-013 Appendex 5 Ease of Use Assessment 
Appendix 6 - EDP-SOP-TNC-013 Proposed Informed Consent Form 
Appendix 7 - EDP-SOP-TNC-013 Proposed Assent Form 

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Study Personnel and Approvals 
 
 
Role 
Name, Title and Contact 
Approval Signature and 
Date 
Clinical 
Investigator 
 
Jason L. Liggett, Ph.D. 
Lead Scientist 
EDP Biotech Corporation 
6701 Baum Drive, Suite 110 
Knoxville, TN 37919 
Office +1 865.299.6228 
Mobile +1 865.604.8665 
 
 
CRO Representative 
 
Eric Mayer  
EDP Biotech Corporation 
6701 Baum Drive, Suite 110 
Knoxville, TN 37919 
Office +1 865.299.6226 
Mobile +1 919.880.8029 
 
 
Sponsor 
Representative 
Dana Hummel 
MP Biomedicals, LLC 
29525 Fountain Parkway 
Solon, OH  44139 
Tel.: +1.800.854.0530, x7019 
Direct.: +1.440.287.7019 
 
 
 
 
 
 
 
 
 

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1.0 Introduction 
1.1 Device Name (working name) 
Rapid SARS-CoV-2 Antigen Test (MP Biomedicals, LLC 29525 Fountain Parkway, 
Solon, Ohio  44139 USA). 
1.2 Intended Use 
The Rapid SARS-CoV-2 Antigen Test is an immunochromatography based one 
step in vitro test. It is designed for the rapid qualitative determination of SARS-
CoV-2 virus antigen in anterior nasal swabs from symptomatic and asymptomatic 
individuals. The Rapid SARS-CoV-2 Antigen Test Card shall not be used as the 
sole basis to diagnose or exclude SARS-CoV-2 infection. 
1.3 Background 
Coronavirus disease (COVID-19) is a disease caused by a newly discovered 
coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)1. The 
SARS-CoV-2 is a β-coronavirus, which is enveloped non-segmented positive-sense 
RNA virus 22. It is spread by human-to-human transmission via droplets or direct 
contact, and infection has been estimated to have mean incubation period of 6.4 
days and a basic reproduction number of 2.24–3.58. Among patients with 
pneumonia caused by SARS-CoV-2, fever was the most common symptom, 
followed by cough3. On 11 March 2020, the COVID-19 outbreak was characterized 
as a pandemic by the WHO4. Since then, over 70 million people worldwide have 
been infected with the virus with over 1.5 million deaths attributed to the virus5. 
Laboratory testing for SARS-CoV-2 is currently being performed to determine if 
an individual has active infection via detection of viral RNA or if an individual has 
an immune response to the virus from a previous infection via detection of 
antibodies. 
Specimen collection is a crucial first step in the evaluation of an individual’s SARS-
CoV-2 infection status. The goal of this project is to evaluate human usability of a 
rapid SARS-CoV-2 antigen test for over the counter (OTC) use. Study subjects 
under EDP supervision, either in-person or via video conference, will collect and 
test anterior nasal swab samples. The Rapid SARS-CoV-2 Antigen Test collection 
and testing methodology is viewed as a convenient and inexpensive method to test 
clinical specimens for SARS-CoV-2 and OTC access will improve the availability of 
COVD-19 testing.   
1.4 Principles of the Device 
The COVID-19 Antigen Rapid Test Device detects SARS-CoV-2 viral antigens 
through visual interpretation of color development. Anti-SARS-CoV-2 antibodies 

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are immobilized on the test region of the nitrocellulose membrane. Anti-SARS-
CoV-2 antibodies conjugated to colored particles are immobilized on the 
conjugated pad. A sample is added to the extraction buffer which is optimized to 
release the SARS-CoV-2 antigens from specimen. During testing, the extracted 
antigens bind to anti-SARS-CoV-2 antibodies conjugated to colored particles. As 
the specimen migrates along the strip by capillary action and interacts with 
reagents on the membrane, the complex will be captured by the anti-SARS-CoV-2 
antibodies at the test region. Excess colored particles are captured at the internal 
control zone. The presence of a colored band in the test region indicates a positive 
result for the SARS-CoV-2 viral antigens, while its absence indicates a negative 
result. A colored band at the control region serves as a procedural control, 
indicating that the proper volume of specimen has been added and membrane 
wicking is working. (See Appendix 1).  
2.0 
Scientific Objectives 
2.1  
Study Rationale 
Traditional specimen collection techniques used in conjunction with respiratory 
infectious agent identification, for examples nasopharyngeal (NP) swabbing or 
aspiration, are often uncomfortable for the patient. Anterior nasal (AN) swab 
samples have provided a more comfortable sampling alternative to NP swabs that 
is also less technically challenging. With ease of use and convenience for OTC 
home specimen collection with the Rapid SARS-CoV-2 Antigen Test, the patient 
experience may lead to better patient sampling for SARS-CoV-2 testing. 
2.2 
Study Objectives 
The objective of the study is to evaluate the usability of the Rapid SARS-CoV-2 
Antigen Test in a home setting. The main focus will be to assess the clarity and 
robustness of the instructions for use. 
3.0 
Study Materials 
EDP Biotech Corp. will obtain the Rapid SARS-CoV-2 Antigen Test kits and 
materials to perform the collection and testing from the respective manufacturers. 
EDP Biotech Corp. will maintain proper storage conditions of all reagents per the 
manufacturers’ product package inserts. 
3.1 Specimen Collection Materials/Equipment 
All Rapid SARS-CoV-2 Antigen Test materials are ready for use as per 
Manufacturer’s instructions. The materials will be used prior to expiration dating. 
 
 

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         Table 1 Rapid SARS-CoV-2 Antigen Test Materials 
Material 
Manufacturer 
Catalog Number 
Storage 
Rapid SARS-
CoV-2 Antigen 
Test Card 
(sealed foil 
pouch) 
MP Biomedicals 
Solon, OH USA 
 
Ambient 
(15-25ºC) 
Sterile swab 
Goodwood Medical 
Care Ltd.  
1-2 Floor, 3-919 
Yongzheng Street, 
Jinzhou District, Dalian, 
116100 Liaoning, China 
 
Ambient 
(15-25ºC) 
Extraction tube 
MP Biomedicals 
Solon, OH USA 
 
Ambient 
(15-25ºC) 
Extraction 
solution bottle 
MP Biomedicals 
Solon, OH USA 
 
Ambient 
(15-25ºC) 
Instructions for 
use (IFU) 
MP Biomedicals 
Solon, OH USA 
 
Ambient 
(15-25ºC) 
Tube stand 
MP Biomedicals 
Solon, OH USA 
 
Ambient 
(15-25ºC) 
                      
3.2 
Computer Hardware and Software 
For this study, results will be analyzed using: 
➢ PC Computer Platform. 
➢ Microsoft Office Excel, version 2003 (or higher). 
3.3 
Collection/Storage/Transfer of Data Files 
All data will be collected and stored by EDP Biotech Corp. using its established 
laboratory information systems (LIS) upon completion of the initial testing or 
resolution of incomplete or disqualified runs. Results will be compiled as a 
specimen log as part of the clinical study documentation. 
If applicable, all original instrument data printouts will be maintained as part of 
the study records.  Additionally, records of personnel performing all assays, all 
instruments, reagent and control lots used for each assay run will be maintained. 
Note: All required ancillary equipment and materials for the study are specified in 
appropriate Standard Operating Procedures (SOPs), along with the instrument 
operator’s manuals and reagent instructions for use (package insert) at EDP 
Biotech Corp.   

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4.0 
Study Design 
This is a clinical study to evaluate the feasibility of using anterior nasal (AN) 
swabs on Rapid SARS-CoV-2 Antigen Test kits for OTC use in symptomatic and 
asymptomatic individuals following recommendations from the FDA’s July 29, 
2020 Template for Manufacturers of Molecular and Antigen Diagnostic COVID-19 
Tests for Non-Laboratory Use, Section J 7. EDP Biotech Corp. will recruit subjects 
for an at home human usability study through the internet as well as by referral 
throughout the United States. Rapid SARS-CoV-2 Antigen Test specimen 
collection and testing will be done under the supervision of EDP Biotech Corp. 
either in person or via video conference. Testing will be observed by EDP Biotech 
Corp. medical professionals or designees either in person or via video conference. 
The study subjects shall perform the entire workflow including sample collection, 
testing, and results interpretation. Following results interpretation, subjects will 
complete a usability and ease of use questionnaires. The data collected in study 
may be submitted as a regulatory filing to the US FDA or other agencies. All 
specimens will be collected from participating consenting subjects. Additional 
testing of the specimens for research purposes may be performed. The study 
acceptance criteria is a 95% success rate for subjects producing the control line on 
the Rapid SARS-CoV-2 Antigen Test and a SUS average score of 68 or greater. 
4.1 
Site Characteristics 
EDP Biotech Corp. is currently offering specimen collection for patient SARS-CoV-
2 testing in a clinic setting. For referral and internet recruiting and specimen 
collection, EDP personnel will observe specimen collection and testing from 
patients in their homes or by remote visual monitoring via video conference after 
consenting. The site has a CLIA certificate (44D2184836) and has the requisite 
infrastructure to perform molecular testing. EDP Biotech Corp. is currently 
offering SARS-CoV-19 testing to patients.  All personnel involved in the study will 
be qualified by education and experience to conduct this study and agree to follow 
the study protocol.   
4.2 
Site Personnel 
EDP Biotech Corp. management of the laboratory involved in this evaluation is 
responsible for assignment of qualified personnel and for maintaining documented 
required qualifications for those personnel.   
4.3 
Specimen Collection 
Each potential subject will be asked to complete a form describing any symptoms 
of respiratory illness being experienced, education level, and basic demographics 
(Appendices 2 and 3). Subjects will be observed by EDP Biotech Corp. personnel or 

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designees during sample collection, testing, and shipment preparation either in 
person or via video conference. 
Each study volunteer who agrees to participate in the study will be asked to 
complete an Informed Consent Form (Appendix 6). A parent or guardian will need 
to consent for subjects under 18 years old. Study subjects between the ages of 7 
and 17 years old will be asked to complete an Assent form (Appendix 7). 
Specimens will be collected and tested only after the Informed Consent form is 
completed. Each study volunteer will be assigned a unique specimen identification 
number (SID). The Clinical Investigators or designees will observe AN swab 
collection and testing. Subjects will collect AN swab samples and perform the 
Rapid SARS-CoV-2 Antigen Test using only the IFU for instruction or video linked 
from the IFU. The collection devices and storage tubes will be appropriately 
labeled with the SIDs and not the names of the participants to maintain 
confidentiality. 
Rapid SARS-CoV-2 Antigen Test AN swab specimens will be collected and tested 
per the product directions that accompany the device (Appendix 1). Following 
Rapid SARS-CoV-2 Antigen Test, subjects will complete a System Usability Scale 
questionnaire (Appendix 4) and an Ease of Use assessment including 
interpretation of mock test cassettes (Appendix 5). 
 
4.4 
Sample Types and Numbers 
Subjects will be enrolled in an “all comers” style, including both symptomatic and 
asymptomatic patients. The study population will include subjects from 2 years 
old to greater than 65 years old. Minors must be consented by their parent or legal 
guardian. The parent or legal guardian should collect the samples and perform 
testing if the child is between 2 and 13 years old. Older children ages 14-17 should 
collect their samples and perform their tests without their parent or legal 
guardian intervening. The study will include two sections, 50 subjects testing 
themselves and 50 subjects testing another person such as children between the 
ages of 2 and 13 years old. Enrollment efforts in various zip codes will be pursued 
in order to represent different socioeconomic and educational backgrounds and 
this information will be captured in the tester questionnaire (Appendix 2) and 
subject questionnaire (Appendix 3). A portion of the study population should 
include Spanish speaking users. High risk individuals will not be excluded. 
Participants who regularly use home diagnostic tests, such as glucose meters, will 
be excluded. Study testing will continue until the full range of 2-65+ ages are 
tested including at least 50 self-tests and 50 tests performed by subjects on other 
participants.  

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4.5 
Sample Handling and Management 
Study specimens will be accessioned into the EDP Biotech Corp. system using 
assigned unique identifying number to facilitate tracking and identification 
during analysis. A visual inspection (in person or via online observation) of the 
specimens will be made to ensure the specimens meet study requirements for 
proper appearance.  
5.0 
Sample Preparation and Testing Procedure 
5.1 
Instrument Set-Up (Calibration and Quality Control) 
All lateral flow kit quality controls and instrument quality control and calibration 
procedures will be performed per manufacturer’s recommendations or the 
laboratory’s QA/QC manual, as appropriate.  Instrument calibration and 
instrument performance will be documented on each day that testing is 
performed. All documentation related to the operation of the instrument will be 
completed, verified and recorded per the laboratory’s standard procedures.  
5.2 
Reagent Preparation  
All reagents will be prepared for use by lateral flow kit manufacturer or EDP 
Biotech Corp. laboratory personnel, as appropriate or as specified in their 
respective manufacturer’s package insert/instruction for use documents. 
5.3 
Specimen Processing 
Individuals participating in the usability study will process their own specimens 
or specimens of another individual, as appropriate, at the time of enrollment and 
testing EDP Biotech Corp personnel will process the collected AN swab specimen 
data as it is generated.  
5.4 
Sample Preparation 
SARS-CoV-2 antigen will be extracted from the collected specimens using 
procedures provided by the investigational lateral flow kit manufacturers. The 
specifications for specimen integrity described in the manufacturer’s instrument 
instructions will be followed, i.e., storage conditions prior to testing. 
5.5 
Control/Calibrator Preparation 
Assay controls will be included in each test run per manufacturers’ directions.   

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5.6  
Assay Testing 
Testing of the study specimens will be performed as follows. 
AN swab specimens will be evaluated at the time of collection by study subjects 
observed by EDP Biotech Corp. personnel either in person or via video conference 
(Appendix 6). Testing will be performed according to the specific EDP Biotech 
Corp.  Standard Operating Procedures associated with this test. Specimens will be 
tested per specimen stability parameters in the product instructions (Appendix 1). 
There is no specific requirement to run a pre-defined number of specimens per 
run.  
5.7 
Reporting of Results 
The results obtained with the Rapid SARS-CoV-2 Antigen Test will be captured 
electronically in the EDP Biotech Corp. LIMS system by observers.  
6.0 
Data Management and Analysis 
6.1 
Sample ID Numbers and Identification  
Each sample entered into the study will be assigned the study sample 
number during accessioning.  A data management log listing each sample 
number and storage information will be maintained. 
6.2 
Data Evaluation and Accessibility 
A report tabulating and analyzing the data will be prepared by the Clinical 
Investigator including tables of the results and a description of any 
deviations from the protocol. 
6.2.1 Acceptability of Data for Analysis 
Valid individual specimen results generated in invalid runs are not 
acceptable for inclusion in final data analysis.  Samples tested in 
invalid runs must be re-tested if the remaining specimen volume is 
available.  Only valid results from specimens in valid runs will be 
included in the final data analysis.  
6.2.2 Exclusion of Data from Analysis 
Data from invalid runs results will be excluded. All excluded results 
will be documented with rationale for exclusion and a summary of 
these cases will be provided. 
6.2.3 Data Entry and Corrections to Study Documents 

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All entries must be legible and made in indelible ink (preferably black); 
do not use pencil. Strike incorrect entries with a single line (do not 
obliterate or put "white-out" on the original entry).  Then enter the 
correct information next to the original entry, initial, and date the 
correction.  
6.2.4 Assay Run Data 
Any Printouts corresponding to assay runs will be maintained and a 
copy placed in a study binder. A record will be maintained regarding 
assay reagents and calibrators by lot number and expiration date. 
 
6.2.5 Invalid Results 
Invalid results will be repeated either by the same subject or a different subject 
until the criteria found in section 4.4 is met. 
 
         6.3 Data Analysis 
6.3.1 Acceptance Criteria for Method Comparison 
The study sponsor will ensure that all specimens are analyzed 
appropriately, and results are accurately transcribed to an excel 
spreadsheet for analysis.  
7.0 
Documentation 
7.1 
Data Reporting Forms and Tracking Log Sheets 
Any required forms regarding study data or material inventory tracking (for 
specimens or assay reagents) will be completed in ink (black ball-point pen is 
preferred). Entries made with pencil are not allowed.  When completing forms, do 
not leave blanks.  If an item is missing, complete the entry with ‘ND’ for ‘not done’ 
or ‘NA’ for ‘not available/applicable,’ as appropriate. 
All changes or corrections to any original document must be made in ink and 
initialed and dated by the person making the change.  Incorrect data should be 
indicated by lining through the entry with a single line.  Do not erase or use 
correction fluid (“White-Out” or “Liquid Paper”) or eradicate the entry in any other 
way.  The correct value should be written next to the item in question and circled.  
Each page with corrections must be initialed and dated by the technician 
performing the assay. 
Assigned EDP Biotech Corp. personnel responsible for entries made to any study 
form will provide a signature and date on each form sheet upon completion. The 

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Clinical Investigators (or designee) must review all study forms related to data 
reporting or material tracking. The Clinical Investigators are ultimately 
responsible for the integrity of the data recorded or submitted on the data 
reporting form. 
7.2 Tester and Subject Questionnaires 
Each tester will complete a tester information form including race and ethnic 
categories, zip code, and language self-assessment (Appendix 2). Each subject will 
be asked to complete a form providing information about exhibited symptoms 
consistent with COVID-19 infection (Appendix 3).  
7.3 Instrument-Generated Printouts 
Any instrument-generated data printed results for each assay run (including all 
valid and invalid runs) must be reviewed for accuracy and signed and dated by the 
Principal Investigator (or designee) and then included in the study regulatory 
binder.  
7.4 Specific Tracking Log Sheets 
All test materials and controls used during the study will be recorded to indicate 
lot and expiration date. 
8.0 
IRB Requirements 
8.1 
Informed Consent 
The study described in this protocol presents a nonsignificant risk of harm to the 
human subjects, as standard procedures are used for the AN swab specimen 
collections. EDP Biotech Corp. has determined Informed Consent (IC) is 
appropriate from individuals to provide specimens for the research study. A 
proposed Informed Consent Form is presented as Appendix 6. 
For this study: 
a) This investigation meets the IDE exemption criteria at 21 CFR 812.2(c) 
(3). 
b) The specimens will not be individually identifiable, i.e., the identity of 
the subject is not known after specimen collection based on the unique identifier 
and may not readily be ascertained by EDP Biotech Corp. employees or any other 
individuals associated with the investigation after the unique SID is assigned. In 
this manner, the specimens will be coded but deidentified, and will be individually 
identifiable by the clinical investigator(s). 
c) The study will be reviewed by an IRB in accordance with 21 CFR Part 56. 

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8.2 
IRB Approval 
This study will be initiated only after IRB Approval of the study has been 
granted.  A copy of the IRB approval document will be maintained by the Clinical 
Investigators in a study binder. 
 
9.0 
Risk Analysis 
This is a non-significant risk device study. The study presents no potential for 
serious risk to the health, safety, or welfare of any human subject as it uses only 
commonly employed techniques for the AN swab specimens. There will be subject 
recruitment at the EDP Biotech Corp. investigative site using public posting, e-
mail correspondence, and referrals. Study results will be used to demonstrate that 
the Rapid SARS-CoV-2 Antigen Test technique is suitable for home use without a 
prescription.   
10.0 Study Master File (SMF) 
The Clinical Investigator (CI) or Designee(s) will collect and review copies of the 
required essential documents (ED) listed below in the form of a Study Master File 
(SMF).  EDP Biotech Corp. is the sponsor of the study and will maintain the SMF 
and copies of the required EDs; the Investigator Site File (ISF) will contain original 
documents. 
10.1 Required Essential Documents 
A binder(s), which for purposes of this clinical study will be defined as the 
investigator site file (ISF), will be maintained at the trial site and serves as 
the central source for ED maintenance at the site.  
The following documents represent a complete site essential document 
packet and are to be maintained in the ISF:  
• 
Clinical Investigator’s (CI) Curriculum Vitae (CV) or Resume. 
• 
CI Human Subject Protection Training documentation. 
• 
Institutional Review Board (IRB)-Approved Protocol and Protocol Amendments. 
• 
Protocol/Protocol Amendment(s) Signature Pages.  
• 
IRB Compliance Documentation. 
• 
Signed informed consent forms. 
• 
Laboratory Certifications, e.g. CLIA. 

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11.0 Monitoring 
The sponsor of this study shall be responsible for ensuring adequate monitoring for 
the study occurs.  The Clinical Investigators will grant the sponsor or designee 
access to the testing site and all applicable study information.  Access will be 
granted to review all study documents and all Regulatory documentation (site 
binders containing completed ICFs and IRB approval). Monitoring of the study will 
be conducted on a periodic basis throughout the evaluation. Closeout monitoring of 
the study will be conducted. Reports of the monitoring will be prepared. Any 
deficiencies observed during the monitoring will be discussed with the Clinical 
Investigator for remediation. Monitoring may be conducted remotely. 
12.0 Investigational Study Site Compliance 
12.1 
Investigator Responsibility 
The Clinical Investigators (CI) are expected to ensure that the methods and study 
design outlined in this protocol are followed.  No changes to protocol methods or 
study design can be made without the written consent of the sponsor.  It is the 
responsibility of the sponsor and the CIs to ensure subject confidentiality and IRB 
approval for the study. 
12.2 
Site Monitoring and Inspection 
The sponsor will maintain close liaison with the study Investigators to answer any 
questions that may arise and to ensure that the study is being conducted according 
to this protocol.  The study site will permit the sponsor and or its designee to visit 
the site at reasonable times to audit or inspect the study records and materials.  
Sponsor personnel will audit the progress and compliance of the study and at the 
end of the study for closeout. 
12.3 
Record Retention 
Study records will be maintained by the Clinical Investigators and Study Sponsor 
per EDP Biotech Corp. SOPs. Copies of all data generated from the study, all data 
reporting forms, and records of reagent disposition are to be maintained for a 
period of 5 years following the date on which the entire clinical investigation is 
terminated or discontinued.  
13.0 Biological Safety 
13.1 
Toxicity and Complications 
Not applicable.  
13.2 
Sample Handling 

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All volunteer specimens and materials with which the study personnel come into 
contact should be handled as if capable of transmitting infection, and dispensed of 
with precautions in accordance with Federal, State, and Local regulations. 
14.0 Modifications to the Protocol 
14.1 
Protocol Amendments 
Neither the Clinical Investigators nor study laboratory personnel will modify this 
protocol without contacting the Study Sponsor.   
14.2 
Study Termination 
For any reasonable cause, the Study Sponsor may terminate the study, provided a 
written notice is submitted at least 30 days in advance of the intended 
termination. The IRB will be notified if the study is terminated. 
15.0 Abbreviations 
The abbreviations that are given below apply: 
           
 
 
      15.1 Abbreviations 
C 
Celsius (Centigrade) 
g 
Microgram 
l 
Microliter 
AMR 
Analytical Measurement Range 
AN 
Anterior nasal (nares) 
CFR 
Code of Federal Regulations 
dL 
One-tenth of a liter 
d 
Day 
FDA 
Food and Drug Administration  
hrs 
Hours 
IC 
Informed Consent 
ID 
Identification or identification number 
IDE 
Investigational Device Exemption 
IFU 
Instructions for use 
IRB 
Institutional Review Board 
IUO 
Investigational use only 
LIS 
Laboratory information system 
mL 
Milliliter 
N 
Number 
NA 
Not applicable or not available 

COVID-19 Rapid Ag Usability Study 
EDP Biotech Corporation Confidential 
 
 
 
 
Rev. B 
 
 
 
 
17
ND 
Not done 
Ng 
Nanogram 
OTC 
Over the counter 
PI 
Principal Investigator 
QC 
Quality Control 
RT 
Room temperature (ambient) 
RUO 
Research Use Only 
SOP 
Standard Operating Procedure 
wks 
Weeks 
 
16. References 
1. Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease 
(COVID- 
19) outbreak. J Autoimmun. 2020;109:102433. doi:https://doi.org/10.1016/j.jaut.2020.102433 
2. Guo Y-R, Cao Q-D, Hong Z-S, et al. The origin, transmission and clinical therapies on 
coronavirus disease 2019 (COVID-19) outbreak – an update on the status. Mil Med Res. 
2020;7(1):11. doi:10.1186/s40779-020-00240-0 
3. Lai C-C, Shih T-P, Ko W-C, Tang H-J, Hsueh P-R. Severe acute respiratory syndrome 
coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19): The epidemic and the 
challenges. Int J Antimicrob Agents. 2020;55(3):105924. 
doi:https://doi.org/10.1016/j.ijantimicag.2020.105924 
4. WHO. No Title 
5. Johns Hopkins University Center for Health Security Website. 2020. 
https://www.centerforhealthsecurity.org