Over the Counter Rapid Antigen Test for Detection of SARS-CoV-2 Virus: Clinical Evaluation
Phase: NA
Conditions: SARS-CoV2 Infection, COVID-19
Sponsor: MP Biomedicals, LLC

MP Biomedicals Rapid SARS-CoV-2 Antigen Test OTC: Clinical Evaluation 
EDP Biotech Corporation Confidential 
 
 
 
 
 
 
Over the counter Rapid Antigen Test for detection of 
SARS-CoV-2 virus: Clinical Evaluation  
 
 
August 13, 2021 
Updated November 3, 2021 
Updated December 1, 2021 
 
 
 
Protocol Number:  
EDP-SOP-TNC-014 
 
 
 
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. C 
 
 
 
 

MP Biomedicals Rapid SARS-CoV-2 Antigen Test OTC: Clinical Evaluation 
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For Investigational Use Only. 
 The performance characteristics of this device  
have not been established  
Contents 
List of Tables ........................................................................................................................................... 4 
List of Appendices ................................................................................................................................... 4 
Study Personnel and Approvals ............................................................................................................... 5 
1.0 Introduction ........................................................................................................................................ 6 
1.1 Device Name (working name) ........................................................................................................ 6 
1.2 Intended Use ................................................................................................................................... 6 
1.3 Background ..................................................................................................................................... 6 
1.4 Principles of the Device .................................................................................................................. 7 
2.0 
Scientific Objectives ..................................................................................................................... 7 
2.1  
Study Rationale ......................................................................................................................... 7 
2.2 
Study Objectives ....................................................................................................................... 7 
3.0 Study Materials .................................................................................................................................. 8 
3.1 
Specimen Collection Materials/Equipment ............................................................................... 8 
3.2 
PCR Testing Reagents ............................................................................................................... 8 
3.3 
Instrumentation.......................................................................................................................... 9 
3.4 
Computer Hardware and Software ............................................................................................ 9 
3.5 
Collection/Storage/Transfer of Data Files................................................................................. 9 
4.0 
Study Design ............................................................................................................................... 10 
4.1 
Site Characteristics .................................................................................................................. 10 
4.2 
Site Personnel .......................................................................................................................... 10 
4.3 
Specimen Collection ............................................................................................................... 10 
4.4 
Sample Types and Numbers .................................................................................................... 12 
4.5 
Exclusion Criteria .................................................................................................................... 13 
4.6 
Sample Handling and Management ...................................................................................... 123 
5.0 
Sample Preparation and Testing Procedure ................................................................................ 13 
5.1 
Rapid SARS-CoV-2 Antigen Test .......................................................................................... 13 
5.2 
Instrument Set-Up (Calibration and Quality Control)............................................................. 13 
5.3 
Reagent Preparation ................................................................................................................ 14 
5.4 
Specimen Processing ............................................................................................................... 14 
5.5 
Sample Preparation ................................................................................................................. 14 
5.6 
Sample Transport .................................................................................................................... 15 
5.7 
Sample Storage ........................................................................................................................ 15 

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5.8 
Control/Calibrator Preparation ................................................................................................ 15 
5.9 
Assay Testing .......................................................................................................................... 15 
5.10 
Discrepant Analysis................................................................................................................. 15 
5.11 
Reporting of Results ................................................................................................................ 15 
5.12 
Adverse Events (AEs) ............................................................................................................. 15 
5.13 
Device Malfunctions ............................................................................................................... 16 
6.0 
Data Management and Analysis ................................................................................................... 16 
6.1 
Sample ID Numbers and Identification ................................................................................... 16 
6.2 
Data Evaluation and Accessibility .......................................................................................... 16 
6.2.1 
Acceptability of Data for Analysis .................................................................................. 17 
6.2.2 
Exclusion of Data from Analysis ..................................................................................... 17 
6.2.3 
Data Entry and Corrections to Study Documents ............................................................ 17 
6.2.4 
Assay Run Data................................................................................................................ 17 
6.2.5 
Discordant Results ........................................................................................................... 17 
6.3 
Data Analysis .......................................................................................................................... 17 
6.3.1  
Acceptance Criteria for Method Comparison .................................................................. 17 
7.0 
Documentation ............................................................................................................................ 18 
7.1 
Data Reporting Forms and Tracking Log Sheets .................................................................... 18 
7.2 
Subject Questionnaire ............................................................................................................. 18 
7.3 
Instrument-Generated Printouts .............................................................................................. 18 
7.3 
Specific Trackin Log Sheets ................................................................................................... 18 
8.0 
IRB Requirements ....................................................................................................................... 19 
8.1 
Informed Consent .................................................................................................................... 19 
8.2 
IRB Approval .......................................................................................................................... 19 
9.0 
Risk Analysis ................................................................................................................................ 19 
10.0 Study Master File (SMF) ............................................................................................................ 20 
10.1 
Required Essential Documents................................................................................................ 20 
11.0 Monitoring .................................................................................................................................. 20 
12.0 Investigational Study Site Compliance ....................................................................................... 20 
12.1 
Investigator Responsibility ...................................................................................................... 21 
12.2 
Site Monitoring and Inspection ............................................................................................... 21 
12.3 
Record Retention ..................................................................................................................... 21 
13.0 Biological Safety ......................................................................................................................... 21 
13.1 
Toxicity and Complications .................................................................................................... 21 
13.2 
Sample Handling ..................................................................................................................... 21 
14.0 Modifications to the Protocol...................................................................................................... 21 
14.1 
Protocol Amendments ............................................................................................................. 21 
14.2 
Study Termination ................................................................................................................... 21 
15.0 Abbreviations .............................................................................................................................. 22 
16.0 References ................................................................................................................................... 23 
 
 

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List of Tables 
 
Table 1- Rapid SARS-CoV-2 Antigen Test Materials……...………………………………..…………8 
Table 2- Collection Materials for Nasal Swab Specimens………...……………………………………9 
 
List of Appendices 
 
Appendix 1 - EDP-SOP-TNC-014 CDC EUA Letter 
Appendix 2 - EDP-SOP-TNC-014 CDC IFU (Instructions For Use) 
Appendix 3 - EDP-SOP-TNC-014 Tester Information Form 
Appendix 4 - EDP-SOP-TNC-014 Subject Information Form 
Appendix 5 - EDP-SOP-TNC-014 User Comprehension Assement 
Appendix 6 - EDP-SOP-TNC-014 Rapid Ag IFU (Instructions For Use) v7 
Appendix 7 - EDP-SOP-TNC-014 Proposed Informed Consent Form 
Appendix 8 - EDP-SOP-TNC-014 Proposed Assent Form 
Appendix 9 - EDP-SOP-TNC-014 CDC’s Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay EUA 
Letter 
Appendix 10 - EDP-SOP-TNC-014 CDC’s Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay EUA 
Summary 
 
 
 
 
 

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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 MP Biomedicals Rapid SARS-CoV-2 Antigen Test is an 
immunochromatography based one step in vitro test intended to detect 
nucleocapsid antigen from the SARS-CoV-2 virus that causes COVID-19. 
It is designed for over the counter (OTC) rapid qualitative determination 
of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals 
within 7 days of symptom onset or without symptoms or other 
epidemiological reasons to suspect COVID-19 infection. This test is for 
non-prescription home use with self-collected anterior nasal swab 
specimens directly from individuals aged 14 years and older or with 
adult-collected anterior nasal samples directly from individuals aged 2 
years or older.  
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 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 and a Study Representative will collect and ship a second nasopharyngeal 
swab sample for comparator PCR testing. The Rapid SARS-CoV-2 Antigen Test 

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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 
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 6).  
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 feasibility of using Rapid SARS-CoV-2 
Antigen Test detection of SARS-CoV-2 virus in OTC home use. The presence of 
SARS-CoV-2 virus will be confirmed by PCR methodology. Testing will be 
performed with EUA PCR tests. The acceptance criteria for this study is Positive 
Percent Agreement (PPA) greater than or equal to eighty percent and Negative 
Percent Agreement (NPA) greater than or equal to ninety-eight percent). 
 

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3.0 
Study Materials 
EDP Biotech Corp. will obtain the Rapid SARS-CoV-2 Antigen Test kits and swab 
collection supplies, and Diversified Medical Health (DMH) Premier Laboratories 
will obtain the PCR reagents and materials to perform the 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. 
         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 
Zhejiang Gongdong 
Medical Technology 
Co., Ltd 
No. 10 Beiyuan Ave., 
Huangyan, 318020 
Taizhou, Zhejiang, 
P.R.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 
PCR Collection Materials 
Nasopharyngeal swab specimens will be evaluated for the presence of SARS-CoV-
2 RNA with the DMH Premier  
CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC) at their Premier 
Laboratory facility in Greenville, SC (see Appendices 1 and 2). 

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Table 2- PCR Collection and Shipping Materials for Nasopharyngeal swab Specimens:  
Material 
Manufacturer/ 
Vendor 
Catalog  
Number 
Storage
1 
Sterile Swab 
Premier 
 
Ambient 
(15-25ºC) 
Tube Label 
Premier 
 
Ambient 
(15-25ºC) 
Collection Tube with 
Universal Transport 
Media 
Premier 
 
Ambient 
(15-25ºC) 
Collection Instructions 
Premier 
 
Ambient 
(15-25ºC) 
Biohazard bag with 
absorbent pad 
Premier 
 
Ambient 
(15-25ºC) 
Shipping box with cold 
pack 
Premier 
 
Ambient 
(15-25ºC) 
   
3.3 
Instrumentation 
Testing of collected respiratory specimens associated with this protocol will be 
performed with the following equipment: 
 
3.2.1 For nasal swab specimens at DMH Premier Laboratory: 
• QuantStudio 12 K Flex Real-Time PCR System (Thermo Fisher 
Scientific) 
3.4 
Computer Hardware and Software 
For this study, results will be analyzed using: 
➢ PC Computer Platform. 
➢ Microsoft Office Excel, version 2003 (or higher). 
3.5 
Collection/Storage/Transfer of Data Files 
All data will be collected and stored by EDP Biotech Corp. using its established 
laboratory information system (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 

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operator’s manuals and reagent instructions for use (package insert), either at 
DMH Premier Laboratories or EDP Biotech Corp.   
 
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 November 
9, 2021 Template for Developers of Molecular and Antigen Diagnostic COVID-19 
Tests for Home Use , Sections J 8, 9. EDP Biotech Corp. will recruit subjects for a 
clinical study through the internet as well as by referral throughout the United 
States. Rapid SARS-CoV-2 Antigen Test anterior nasal specimen collection and 
testing will be done under the supervision of EDP Biotech Corp. or designee in 
person. Standard of care (SOC) comparator NP samples will be collected at least 
15 minutes prior to Ag samples with at least 15 minutes between nasal collections 
including collections that may occur prior to study enrollment. Comparator SOC 
samples will be collected first by qualified personnel at a study site or physician’s 
office using an FDA authorized nasopharyngeal swab collection kit and SARS-
CoV-2 molecular assay. An observed usability study will be conducted prior to this 
clinical evaluation study. Comparator SOC nasopharyngeal swab specimens will 
be analyzed at Premier Laboratories according to this protocol and specific assay 
standard operating procedure (SOP) instructions. 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. A single randomly generated 
non-repeating study ID number will be assigned to subject or subject and tester if 
a parent or legal guardian is testing a 2 to 13 year old and this study ID number 
will be applied to all informed consent and authorization forms, assent forms, 
tester information form, subject information form, user comprehension 
assessment, and any other documents associated with each valid Rapid SARS-
CoV-2 Antigen test result. 
4.1 
Site Characteristics 
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 
Each site in this evaluation is responsible for assignment of qualified personnel 
and for maintaining documented required qualifications for those personnel.   
4.3 
Specimen Collection 

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Each study volunteer who agrees to participate in the study will be asked to 
complete an Informed Consent Form (Appendix 7). A parent or guardian will need 
to consent for subjects under 18 years old. Study subjects between the ages of 7 
and 13 years old will be asked to complete an age-appropriate Assent form 
(Appendix 8). Study subjects between ages 14 and 17 will complete the assent 
portion of the Informed Consent Form (Appendix 7). Minors between the ages of 2 
and 13 years old will have their samples collected and tested by a parent or legal 
guardian. Minors between the ages of 14 and 17 will collect and test their own 
samples without interference from their parents or legal guardians. Specimens 
will be collected and tested only after the Informed Consent form is completed.  
 
Each testing participant will be asked to complete a tester information form 
assessing basic demographics and socio-economic questions (Appendix 3). Each 
subject being tested will be asked to complete a subject information form 
describing any symptoms of respiratory illness and/or resent exposure to 
confirmed COVID-19 positive individuals within the last two weeks (Appendix 4). 
If the tester is self-collecting, then they skip the second half of the subject 
information form as indicated on the form due to redundancy of demographic and 
socio-economic information recorded on the tester information form. Subjects and 
testers will be observed by EDP Biotech Corp. personnel or designees during 
sample collection and testing process in person. The same unique study ID 
number will be associated with all forms and documents related to a single valid 
Rapid SARS-CoV-2 Antigen test result.  
 
The NP swab collection will not provide participants additional training because 
the collection technique differs from AN collection. Participants will be reminded 
that the study representative is performing a different collection technique for a 
different test and that the participant should refer only to the instructions for use 
for the proper collection technique.  
 
The Clinical Investigators or designees will observe AN swab collection and 
testing and ensure that the nasopharyngeal swab comparator PCR specimens 
from each participant are properly collected according to the protocol. NP samples 
will be collected according to the Interim Guidelines for Collecting, Handling, and 
Testing Clinical Specimens for COVID-19 using materials approved for use with 
CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC) provided by DMH 
Premier including synthetic tip swabs with a plastic or aluminum shaft and VTM, 
UTM, or PBS transport media. Subjects will collect AN swab samples and perform 

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the Rapid SARS-CoV-2 Antigen Test using only the IFU (Appendix 7) or 
instructional video (link contained within the IFU) for instruction. The collection 
devices and storage tubes will be appropriately labeled with the study ID numbers 
and not the names of the participants to maintain confidentiality. The same 
unique study ID number will be applied to all forms and sample(s) associated with 
a single Rapid SARS-CoV-2 Antigen Test Card valid result.  
Following Rapid SARS-CoV-2 Antigen Test, subjects will complete a questionnaire 
gauging user comprehension of results and consequences of performing the Rapid 
SARS-CoV-2 Antigen test incorrectly (Appendix 5). Replacement Rapid SARS-
CoV-2 Antigen Test Cards will be provided to re-test invalid results. Repeated 
results will be noted. 
 
Qualified personnel will follow instructions for collection of CDC 2019-nCoV Real-
Time RT-PCR Diagnostic Panel (CDC) used by DMH Premier for comparator 
nasopharyngeal swab sample collection and shipment (Appendices 1 and 2). 
  
4.4 
Sample Types and Numbers 
 
Both AN swab specimens and comparator nasopharyngeal swab specimens will be 
collected for detection of SARS-CoV-2. 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. 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 subject and tester questionnaires (Appendix 4 & 5). High risk individuals 
will not be excluded. Participants who regularly use home diagnostic tests, such 
as glucose meters, or are trained medical or laboratory professionals will be 
excluded.  
Study testing will continue until at least 30 PCR confirmed positives are collected, 
30 PCR confirmed negatives are collected, and 25 samples are collected from 
minors between the ages of 2 and 13. Ideally these 30 positives should include at 
least 10 asymptomatic PCR positive subjects. Specimen collection may be 
terminated once the 30 SARS-CoV-2 RNA positive specimens and 60 total 
specimens have been accrued preferably including at least 10 asymptomatic 

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positive subjects. The FDA may require additional enrollments in order to collect 
at least 10 asymptomatic positive subjects.  
4.5 
Exclusion criteria 
Subjects less than 2 years old will be excluded. Participants with prior medical or 
laboratory training or prior experience with self-collection or self-testing 
(including infectious disease home tests) will be excluded. High risk individuals 
will not be excluded unless they are too young or have prior training or experience 
that would exclude them. 
4.6 
Sample Handling and Management 
Nasopharyngeal swab specimens after collection will be labeled and stored at 2-
8°C prior to shipment on ice packs and testing.  
Study specimens will be accessioned into either the DMH Premier Laboratories 
system (comparator nasopharyngeal swab samples) or the EDP Biotech Corp. 
system using assigned unique identifying number to facilitate tracking and 
identification during analysis. A visual inspection of the specimens will be made to 
ensure the specimens meet study requirements for volume content and proper 
appearance. Specimens may be stored refrigerated (2-8°C) prior to testing per the 
testing protocols for each specimen type. 
 
Remnant samples will be maintained frozen for the duration of the study in case 
they are needed for repeat and/or discordant testing. Following completion of the 
study remnant NP samples will be labeled with the subject’s unique study ID 
number which does not visually link to the study subject and stored in -80C 
freezers for as long as space permits for future research testing. 
 
5.0 
Sample Preparation and Testing Procedure 
5.1 
Rapid SARS-CoV-2 Antigen Test 
The study participant will collect the AN swab sample and perform testing 
according the provided instructions for use without assistance from study 
personnel other than to refer the participant to the IFU for guidance. 
5.2 
Instrument Set-Up (Calibration and Quality Control) 
All 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 

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the operation of the instrument will be completed, verified and recorded per the 
laboratory’s standard procedures.  
5.3 
Reagent Preparation  
Ag reagents will be prepared for use by EDP Biotech Corp. laboratory personnel 
as specified in their respective manufacturer’s package insert/instruction for use 
documents.  PCR reagents will be prepared for use by DMH Premier laboratory 
personnel as specified in their respective manufacturer’s package 
insert/instruction for use documents. 
5.4 
Specimen Processing 
Premier Laboratories or Premier Laboratories personnel will process the 
collected nasopharyngeal swab specimens upon receipt. EDP Biotech Corp 
personnel will process the collected AN swab specimen data as it is 
generated. 
5.5 
Sample Preparation 
SARS-CoV-2 RNA will be extracted from the collected specimens using 
procedures provided by the EUA PCR kit manufacturers. The specifications 
for specimen integrity described in the manufacturer’s instrument 
instructions will be followed, i.e., storage conditions prior to testing. 
 
5.6 
Sample Transport  
Specimens must be packaged, shipped, and transported according to the 
current edition of the International Air Transport Association (IATA) 
Dangerous Goods Regulation. Follow shipping regulations for UN 3373 
Biological Substance, Category B when sending potential 2019-nCoV 
specimens. Store specimens at 2-8°C and ship overnight to Premier 
Laboratories  on ice pack. If a specimen is frozen at -70°C or lower, ship 
overnight to Premier Laboratories  on dry ice. 
 
5.7 
Sample Storage 
Remnant NP samples will be stored at -80°C in for the duration of the study 
in case they are needed for re-testing of discrepant results. Following 
completion of the study, samples will be maintained at -80°C while space 
permits in case they are needed for future testing. Remnant NP samples 
will be labeled with the unique study ID number and/or a random ID that 
does not visually link to the study subject.  

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5.8 
Control/Calibrator Preparation 
Assay controls will be included in each test run per manufacturers’ 
directions.   
 
5.9  
Assay Testing 
Testing of the study specimens will be performed as follows: 
Nasopharyngeal swab specimen after transport will be evaluated at 
Premier Laboratories with the  
CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC). Testing will 
be performed according to the specific Premier Laboratories Standard 
Operating Procedures associated with this test (see Appendices 1 and 2). 
AN swab specimens will be evaluated at the time of collection by study 
subjects observed by EDP Biotech Corp. personnel or designee.  Specimens 
will be tested per the manufacturer’s product instructions (Appendix 7).  
 
5.10  Discrepant Analysis 
Discordant results will be re-tested using the CDC’s Influenza SARS-CoV-2 
(Flu SC2) Multiplex Assay FDA EUA SARS-CoV-2 RT-PCR assay 
performed by Premier Laboratories. Results from a Discrepant analysis 
should not be included in the calculation of negative percent agreement 
(NPA) and positive percent agreement (PPA) but may be added to the 
performance table as a footnote. 
 
5.11 
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. Premier Laboratories and/or Premier Laboratories will provide 
the data from the nasopharyngeal swab specimen testing in an electronic 
format. The result of the comparator PCR test will be reported to the 
subject and/or their health care provider. 
 
5.12 
Adverse Events (AEs) 

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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 NP and AN swab 
specimens. Since the study procedures are not greater than minimal risk, 
Serious adverse events (SAEs) are not expected. If any unanticipated 
problems related to the research involving risks to subjects or others 
happen (including SAEs) these will be reported to the IRB, Office for 
Human Research Protections (OHRP), and the study sponsor. AEs that are 
not serious but that are notable and could involve risks to subjects will be 
summarized in narrative or other format and submitted to the IRB, OHRP, 
and sponsor at the time of continuing review. 
 
5.13 
Device Malfunctions 
Any invalid results of the Rapid SARS-CoV-2 Antigen Test will be repeated, 
and the repetition noted. Any invalid results of the nasopharyngeal swab 
comparator will also be repeated, if possible. 
 
6.0 
Data Management and Analysis 
6.1 
Sample ID Numbers and Identification  
Each study site will receive a list of randomly generated non-repeating 
unique study ID numbers (MPB-014-###, if the study size and or duration 
is increased, then additional digits may be added). The same study ID 
number will be assigned to all documents and forms associated with a 
single valid Rapid SARS-CoV-2 Antigen test result including informed 
consent and authorization forms, assent forms, tester information form, 
subject information form, user comprehension assessment, and any other 
documents associated with each valid Rapid SARS-CoV-2 Antigen test 
result. 
Each sample entered into the study will be tracked by the study ID 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. 

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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 
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    Discordant Results 
If any discordant results are generated during the clinical study, 
further testing using a second high-sensitivity EUA PCR method, 
CDC’s Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay performed by 
Premier Laboratories, will be performed with specimens yielding 
discordant results obtained with the initial PCR methodology.  If the 
NP swab sample has been retained and stored properly, and there is 
sufficient sample available, the same sample will be run on the second 
PCR assay.  Both the AN specimen and the nasopharyngeal swab 
specimen can be repeat tested if possible. The results from the 
discrepant analysis will be reported as a footnote in the performance 
table.  The discordancy will not be used to alter the performance data. 
            6.3 Data Analysis 
6.3.1 Acceptance Criteria for Method Comparison 

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The study sponsor or designee will ensure that all specimens are analyzed 
appropriately, and results are accurately transcribed to an excel 
spreadsheet for analysis. Qualitative results from the Antigen Test and 
quantitative results from the PCR Test may be evaluated for concordance 
between the two test methods using standard statistical methods. 
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 
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 Subject Questionnaire 
Each subject will be asked to complete forms providing information about 
exhibited symptoms consistent with COVID-19 infection (Appendix 3 & 4), and 
forms regarding the comprehension of the test (Appendix 5). 
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 

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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 and 
nasopharyngeal 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 
8. 
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 will be individually identifiable by 
the clinical investigator(s) so that study participants can be given the results of 
the nasopharyngeal swab sample analysis for COVID-19 RNA (positive or 
negative). 
c) The samples are provided to the laboratory staff and investigator(s) in a 
de-identified state, i.e., without the name of the subject, thus preventing the 
unintentional release or dissemination of personal information or testing results. 
d) The study will be reviewed by an IRB in accordance with 21 CFR Part 
56. 
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 and nasopharyngeal swab 
specimens.  There will be subject recruitment at the EDP Biotech Corp. 

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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. will maintain the SMF and copies of the required EDs; 
the Investigator Site File (ISF) will contain original documents.  MP Biomedicals is 
the sponsor of the study and will maintain copies of the required EDs as well. 
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. 
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 

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12.1 Investigator Responsibility 
The Clinical Investigator (CI) is 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 
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. 

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15.0 Abbreviations 
The abbreviations that are given below apply: 
           
 
 
      15.1 Abbreviations 
C 
Celsius (Centigrade) 
g 
Microgram 
l 
Microliter 
AE 
Adverse Event 
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 
ND 
Not done 
Ng 
Nanogram 
OTC 
Over the counter 
PI 
Principal Investigator 
QC 
Quality Control 
RT 
Room temperature (ambient) 
RUO 
Research Use Only 
SAE 
Serious Adverse Event 
SOC 
Standard of care 
SOP 
Standard Operating Procedure 
wks 
Weeks 
 

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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