MGC Health COVID-19 & Flu A+B Home Multi Test Usability Study
Phase: NA
Conditions: COVID-19, Influenza A, Influenza B
Sponsor: Medical Group Care, LLC

MGC Health COVID-19 & Flu A+B Home Multi Test Usability Study 
Protocol No.: MGC-1001 
Version 1.0; 16 January 2023 
Confidential 
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MGC Health COVID-19 & Flu A+B Home Multi Test 
Usability Study 
Protocol No: MGC-1001
NCT05732610
 Version Number 1.0 
16 January 2023 
CONFIDENTIALITY STATEMENT 
The information contained in this document and all information provided to you related to the 
Multiplex COVID-19 & Flu A+B Ag Rapid Test is the confidential and proprietary information of 
Medical Group Care and except as may be required by federal, state, or local laws or regulations, 
may not be disclosed to others without prior written permission of the sponsor.  The principal 
investigator may, however, disclose such information to supervise individuals working on the 
protocol, provided such individuals agree to maintain the confidentiality of such information. 

MGC Health COVID-19 & Flu A+B Home Multi Test Usability Study 
Protocol No.: MGC-1001 
Version 1.0; 16 January 2023 
  
 
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TABLE OF CONTENTS 
SPONSOR CONTACT INFORMATION ...................................................................................4 
CRO CONTACT INFORMATION .............................................................................................4 
PROTOCOL APPROVAL PAGE ...............................................................................................5 
INVESTIGATOR PROTOCOL AGREEMENT .......................................................................6 
ABBREVIATIONS ........................................................................................................................7 
STUDY SYNOPSIS .......................................................................................................................8 
1 
INTRODUCTION ................................................................................................................10 
1.1 
Background ......................................................................................................................10 
1.2 
Study Purpose...................................................................................................................10 
1.3 
Risk and Benefit Assessment ..........................................................................................10 
1.4 
Study Device Description ................................................................................................11 
1.5 
Device Output ...................................................................................................................11 
1.6 
For Investigational Use Only ..........................................................................................15 
1.7 
Study Sites.........................................................................................................................15 
1.8 
Study Objectives...............................................................................................................15 
1.9 
Study Design .....................................................................................................................15 
2 
STUDY ENROLLMENT AND WITHDRAWAL .............................................................16 
2.1 
Study Population ..............................................................................................................16 
2.2 
Enrollment Criteria .........................................................................................................16 
2.3 
Study Duration .................................................................................................................17 
2.4 
Subject Withdrawal .........................................................................................................17 
3 
STUDY PROCEDURES ......................................................................................................17 
3.1 
Set Up ................................................................................................................................17 
3.2 
Informed Consent ............................................................................................................17 
3.3 
Subject Enrollment ..........................................................................................................18 
3.4 
Subject Information ............................................................. Error! Bookmark not defined. 
3.5 
Test Procedure .................................................................................................................19 
4 
PREMATURE STUDY TERMINATION OR SUSPENSION ........................................20 
4.1 
Termination or Suspension .............................................................................................20 
4.2 
Circumstances Warranting Termination or Suspension .............................................20 
5 
SAFETY CONSIDERATIONS ...........................................................................................21 
5.1 
Safety Warnings and Precautions ..................................................................................21 
5.2 
Definition of Adverse Events...........................................................................................21 
5.3 
Reporting of Serious Adverse Events .............................................................................21 
5.4 
Possible Risks Associated with Study Procedures ........................................................22 
6 
REGULATORY AND ADMINISTRATIVE REQUIREMENTS ...................................22 
6.1 
Good Clinical Practice .....................................................................................................22 
6.2 
Responsibility of Investigator .........................................................................................23 
6.3 
Sponsor Responsibility ....................................................................................................23 
6.4 
Protocol Deviations ..........................................................................................................23 

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6.5 
Changes to Protocol .........................................................................................................24 
6.6 
Reconciliation of Study Material, Supplies and Samples .............................................24 
7 
STATISTICAL CONSIDERATIONS ................................................................................24 
7.1 
Usability Study and Risk Mitigation for User Errors ..................................................24 
8 
ETHICAL CONSIDERATIONS ........................................................................................25 
8.1 
Institutional Review Board .............................................................................................25 
8.2 
Informed Consent Process ..............................................................................................25 
8.3 
Subject Confidentiality ....................................................................................................25 
9 
DATA MANAGEMENT ......................................................................................................26 
9.1 
Data Management Responsibilities ................................................................................26 
9.2 
Study Records Retention .................................................................................................26 
10 LITERATURE REFERENCES ..........................................................................................26 
11 SUBJECT QUESTIONNAIRE ...........................................................................................27 
 
TABLE OF FIGURES 
Figure 1: 
Positive Results .....................................................................................................12 
Figure 2: 
Negative Result .....................................................................................................13 
Figure 3: 
Invalid Test Result ...............................................................................................13 
 
 

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Version 1.0; 16 January 2023 
  
 
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SPONSOR CONTACT INFORMATION 
Name: Tomaz Lovse 
Title: Owner & General Manager 
 
Medical Group Care 
1035 Collier Center Way,  
Suite 5 
Naples, FL 34110 
Phone: 239-631-1907 
 
CRO CONTACT INFORMATION 
Name: Jim Sergi 
Title: President 
 
CSSi LifeSciences 
1099 Winterson Road 
Suite 136 
Linthicum Heights, MD 21090 
Phone: 415-317-4903 
 
 

MGC Health COVID-19 & Flu A+B Home Multi Test Usability Study 
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PROTOCOL APPROVAL PAGE 
Study Title: 
MGC Health COVID-19 & Flu A+B Home Multi Test Usability Study 
Protocol Number 
MGC-1001 
Version Number 
1.0 
Date of Issue 
16 January 2023 
Sponsor Name and 
Address: 
Medical Group Care 
1035 Collier Center Way, Suite 5 
Naples, FL 34110 
 
I, the undersigned have read and approve this protocol and agree on its content.  It is confirmed 
that the information and guidance given in this protocol complies with scientific principles. 
 
Name and Title 
Signature and Date 
Reviewed and 
approved by: 
Name: 
 
Title: 
________ 
 
 
 

MGC Health COVID-19 & Flu A+B Home Multi Test Usability Study 
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INVESTIGATOR PROTOCOL AGREEMENT 
Protocol Title: 
MGC Health COVID-19 & Flu A+B Home Multi Test Usability Study 
Protocol Number: 
MGC-1001 
By my signature, I 
1. Agree to conduct the study in accordance with the relevant, current protocol and will only 
deviate from the protocol when necessary to protect the safety, rights, or welfare of the 
subject. 
2. Agree to personally conduct or supervise the described investigation. 
3. Agree to inform any patients, or any persons used as controls, that the study product is 
being used for investigational purposes and I will ensure that the requirements relating to 
obtaining informed consent in 21 CFR Part 50 and institutional review board (IRB) 
review and approval in 21 CFR Part 56 are met. 
4. Agree to report to the sponsor adverse experiences that occur in the course of the 
investigation in accordance with the protocol. I have read and understand potential risks 
and side effects of the study product. 
5. Agree to ensure all associates, colleagues, and employees assisting in the conduct of the 
study are informed about their obligations in meeting the above commitments. 
6. Agree to maintain adequate and accurate records. 
7. Ensure that an IRB that complies with the requirements of 21 CFR Part 56 will be 
responsible for the initial and continuing review and approval of the clinical 
investigation.  I agree to promptly report to the IRB all changes in the research activity 
and all unanticipated problems involving risks to human subjects and others.  I will not 
make any changes in the research protocol without consent from the sponsor and will not 
institute those changes in the research protocol until after approved by the sponsor and 
IRB, except where necessary to eliminate apparent immediate hazards to human subjects. 
8. Agree to comply with all other requirements regarding the obligations of clinical 
investigators and all other pertinent requirements in 21 CFR Part 812. 
 
 
_______________________________________________  
______________________ 
Investigator’s Signature 
 
 
 
 
 
 
Date 
 
____________________________________________________ 
Print Name 
 

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Abbreviations 
AE 
Adverse Event 
C 
Control 
CDC 
Centers for Disease Control and Prevention 
CFR 
Code of Federal Regulations 
COVID-19 
Coronavirus Disease 2019 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIV 
Human Immunodeficiency Virus 
ID 
Identification 
IRB  
Institutional Review Board 
LIVD 
Laboratory In Vitro Diagnostics 
LOINC 
Logical Observation Identifiers Names and Codes 
QRI 
Quick Reference Instructions 
SAE 
Serious Adverse Event 
SARS-CoV-2 
Severe Acute Respiratory Syndrome Coronavirus 2 
SNOMED 
Systematized Nomenclature of Medicine 
T 
Test (detection zone) 
US 
United States 
 
 
 

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Study Synopsis 
Title 
MGC Health COVID-19 & Flu A+B Home Multi Test Usability Study 
Protocol Number 
MGC-1001 
Protocol Date 
16 January 2023 
Protocol Version 
1.0 
Study Sponsor 
Medical Group Care 
Study Purpose 
The purpose of this study is to evaluate the usability of the MGC Health 
COVID-19 & Flu A+B Home Multi Test in home use.  
Investigational 
Material/Product 
The MGC Health COVID-19 & Flu A+B Home Multi Test is a lateral 
flow immunochromatographic antibody assay intended for the 
simultaneous qualitative detection and differentiation of the nucleocapsid 
antigen from SARS-CoV-2, influenza A and/or influenza B directly from 
anterior nasal swab specimens obtained from individuals, who are 
suspected of respiratory viral infection within five (5) days of symptom 
onset.  This test is intended for non-prescription home use with self-
collected direct anterior nares swab samples from individuals ages 14 
years and older or adult lay user collected anterior nares swab samples 
from individuals aged 2 to 13 years. 
Study Objective 
The objective of the study is to determine the usability of the MGC 
Health COVID-19 & Flu A+B Home Multi Test in a simulated home use 
environment. 
Study Design 
This is an open label study to evaluate the usability of the MGC Health 
COVID-19 & Flu A+B Home Multi Test using information from the 
Quick Reference Instructions (QRI). 
Inclusion Criteria 
Subjects are eligible for inclusion if the following criteria are met: 
1. An Institutional Review Board (IRB) approved informed consent / 
assent, if applicable, is signed and dated prior to any study related 
activities. 
2. Male and female subjects 2 years of age and older.   
3. Subject is willing to provide a self-collected nasal swab sample.  (If 
the subject is under the age of 14, an adult lay user will collect the 
sample.) 
4. Subject agrees to complete all aspects of the study. 
Exclusion 
Criteria 
A subject is not eligible for inclusion if any of the following criteria 
apply:  
1. Subject has a visual impairment that cannot be restored with glasses 
or contact lenses. 
2. Subject has prior medical or laboratory training. 
3. Subject uses home diagnostics, e.g., glucose meters, HIV tests. 
4. Subject has prior knowledge of their current COVID-19 or flu 
infection status. 

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Target 
Population/ 
Sample Size 
A minimum of 30 completed subjects with a minimum of 15 subjects 
testing themselves and a minimum of 15 subjects testing another person 
(child 2 to 13 years old). 
Site 
Requirements 
1 testing site in the United States  
Study Duration 
The overall study duration is expected to be less than one (1) month, with 
subject participation completed in one visit of approximately one hour.  
Study Endpoints 
Primary Endpoints 
1. Assess the usability of the Quick Reference Instructions (QRI) 
based upon observer evaluation. 
2. Assess the usability of the kit for home use based upon subject 
evaluation. 
 
 

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1 INTRODUCTION 
1.1 
Background 
COVID-19 is a contagious respiratory illness, caused by infection with the novel coronavirus 
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).  This communicable disease 
is easily transmitted through aerosolized droplets containing the infectious virus.  Infections with 
SARS-CoV-2 can have varying degrees of signs and symptoms, ranging from asymptomatic to 
severe.  Individuals infected with SARS-CoV-2 are believed to be contagious from as early as 
two days prior to symptom onset to at least ten days after the onset of symptoms.   
Influenza (Flu) is a contagious respiratory illness caused by influenza viruses that infect the nose, 
throat, and lungs. This communicable disease is also transmitted through droplets containing the 
virus. Influenza (flu) can cause mild to severe illness, and at times can lead to death. There are 
two main types of influenza (flu) viruses: types A and B. The influenza A and B viruses that 
routinely spread in people (human influenza viruses) are responsible for seasonal flu epidemics 
each year. Individuals infected with Flu are believed to be the most contagious in the first three 
to four days after the onset of symptoms, however, they may still spread the virus and have no 
symptoms. Infants and individuals with weakened immune systems who are infected with flu 
viruses may be contagious for longer than seven days.  
The rapid detection of infections and contacts and the implementation of infection control 
measures are critical for mitigation of these viruses. 
The MGC Health COVID-19 & Flu A+B Home Multi Test is a lateral flow 
immunochromatographic antibody assay intended for the simultaneous qualitative detection and 
differentiation of the nucleocapsid antigen from SARS-CoV-2, influenza A and/or influenza B 
directly from anterior nasal swab specimens obtained from individuals, who are suspected of 
respiratory viral infection within five (5) days of symptom onset.  This test is intended for non-
prescription home use with self-collected direct anterior nares swab samples from individuals 
ages 14 years and older or adult lay user collected anterior nares swab samples from individuals 
aged 2 to 13 years. 
1.2 
Study Purpose 
The purpose of this study is to evaluate the usability of MGC Health COVID-19 & Flu A+B 
Home Multi Test in Home Use. 
1.3 
Risk and Benefit Assessment 
1.3.1 
Potential Risks 
The only study-related procedure that could impact subject safety is in the collection of nasal 
specimens from the anterior nares using a nasal swab.  The risks of collecting a specimen using a 

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nasal swab may include symptoms associated with standard collection practices, such as slight 
pain and/or a small amount of bleeding in the nose.   
All subject(s) will be de-identified using a study-specific number at the time of enrollment.  All 
study forms, Case Report Forms (CRFs) and study samples will be labeled with the de-identified 
subject ID number.  No identifiable patient information will be provided to Medical Group Care.  
No patient treatment or management decisions will be based on any results generated during this 
study. 
Information collected for this study is confidential. However, officials of the FDA or other 
regulatory agencies may research records during the ordinary course of conducting their 
functions.  A sponsor representative may also inspect research records to make certain the study 
data is accurate.  The investigator, institution, regulatory agencies, and sponsor will protect the 
confidentiality of the records. 
1.3.2 
Potential Benefits 
The information obtained in this study will not benefit the study subjects directly but may aid 
future patients by helping to rapidly and accurately detect infection caused by SARS-CoV-2, 
influenza A and/or influenza B. 
1.4 
Study Device Description 
The MGC Health COVID-19 & Flu A+B Home Multi Test is a lateral flow 
immunochromatographic antibody assay intended for the simultaneous qualitative detection and 
differentiation of the nucleocapsid antigen from SARS-CoV-2, influenza A and/or influenza B 
directly from anterior nasal swab specimens obtained from individuals, who are suspected of 
respiratory viral infection within five (5) days of symptom onset.  This test is intended for non-
prescription home use with self-collected direct anterior nares swab samples from individuals 
ages 14 years and older or adult lay user collected anterior nares swab samples from individuals 
aged 2 to 13 years. 
1.5 
Device Output 
The MGC Health COVID-19 & Flu A+B Home Multi Test detects influenza A and B viral 
antigens and COVID-19 antigen through visual interpretation of color development on the test 
cassette.  
Nasal swab samples are loaded into the sample port of the test cassette.  The extracted specimen 
reacts with anti- influenza A, B and COVID-19 antibodies conjugated to colored particles and 
precoated onto the sample pad of the test. The mixture then migrates through the membrane by 
capillary action and interacts with the reagents on the membrane.  If there is sufficient influenza 
A and/or B viral antigens or COVID-19 antigens in the specimen, a pink colored band(s) will 
form in the test region(s) of the membrane, i.e., COVID-19, Flu A and/or Flu B, as illustrated in 
Figure 1.  

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If no color bands appear in any of the test regions, this is an indication of a negative result, as 
illustrated in  
 

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Negative Test   
The appearance of a pink line in the control region (C) and the absence of a pink line in the test 
region(s) indicates a negative test result, as shown in Figure 2. 
 
Figure 2. 
The appearance of a colored band at the control region (C) serves as a procedural control, 
indicating that the proper volume of specimen has been added and membrane wicking has 
occurred. If the Control line (C) does not appear, as illustrated in Figure 3, the result is invalid, 
and the test should be repeated.  
Positive Test 
The appearance of a pink line in the control region (C) and a pink line in the test region(s) 
COVID-19, Flu A, and/or Flu B indicates a positive result for the particular viral antigen.  Figure 
1 depicts positive test results.  

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Figure 1: 
Positive Results 
 
 
 

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Negative Test   
The appearance of a pink line in the control region (C) and the absence of a pink line in the test 
region(s) indicates a negative test result, as shown in Figure 2. 
 
Figure 2: 
Negative Result 
 
Invalid Test   
The absence of both a pink control line (C) and a pink line in the test regions or the absence of a 
pink control line (C) with the appearance of a pink line in the test region(s) indicates the test was 
invalid and must be repeated.  This is illustrated in Figure 3. 
Figure 3: 
Invalid Test Result 
 

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1.5.1 
Intended Use 
The MGC Health COVID-19 & Flu A+B Home Multi Test is a lateral flow 
immunochromatographic antibody assay intended for the simultaneous qualitative detection and 
differentiation of the nucleocapsid antigen from SARS-CoV-2, influenza A and/or influenza B 
directly from anterior nasal swab specimens obtained from individuals, who are suspected of 
respiratory viral infection within five (5) days of symptom onset.  This test is intended for non-
prescription home use with self-collected direct anterior nares swab samples from individuals 
ages 14 years and older or adult lay user collected anterior nares swab samples from individuals 
aged 2 to 13 years. 
Results are for the simultaneous identification of SARS-CoV-2, influenza A, and influenza B. 
The MGC Health COVID-19 & Flu A+B Home Multi Test is not intended to detect influenza C 
antigens. These viral antigens are generally detectable in anterior nasal swab specimens during 
the acute phase of infection.  Positive results indicate the presence of viral antigens, but clinical 
correlation with patient history and other diagnostic information is necessary to determine 
infection status.  Positive results do not rule out bacterial infection or co-infection with other 
viruses.  The agent detected may not be the definite cause of disease.  Individuals who test 
positive with the MGC Health COVID-19 & Flu A+B Home Multi Test should self- isolate and 
seek follow-up care with their physician or healthcare provider as additional testing may be 
necessary. 
Negative SARS-CoV-2 results should be treated as presumptive and confirmed with a molecular 
assay, if necessary, for patient management.  Negative results do not rule out SARS-CoV-2 
infection and should not be used as the sole basis for treatment or patient management decisions, 
including infection control decisions.  Negative results should be considered in the context of an 
individual’s recent exposures, history, and the presence of clinical signs and symptoms 
consistent with COVID-19.  
Negative influenza A and B test results should be treated as presumptive.  It is recommended 
these results be confirmed by viral culture or an FDA cleared influenza A and B molecular assay.  
Negative results do not preclude influenza virus infection and should not be used as the sole 
basis for treatment or other management decisions. 
Additional confirmatory testing with a molecular test for positive results may also be necessary, 
if there is a low likelihood of COVID-19 or influenza, such as in individuals without known 
exposures to COVID-19 or influenza or residing in communities with low prevalence of these 
infections.  Individuals who test negative and continue to experience symptoms of fever, cough 
and/or shortness of breath may still have SARS-CoV-2 or influenza and should seek follow-up 
care from their healthcare provider.  Individuals should provide all results obtained with this 
product to their healthcare provider for public health reporting.  All healthcare providers will 
report all test results they receive from individuals who use the authorized product to relevant 
public health authorities in accordance with local, state, and federal requirements using 
appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics 
(LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by the CDC. 

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1.6 
For Investigational Use Only 
The MGC Health COVID-19 & Flu A+B Home Multi Test is a lateral flow 
immunochromatographic antibody assay intended for the simultaneous qualitative detection and 
differentiation of the nucleocapsid antigen from SARS-CoV-2, influenza A and/or influenza B 
directly from anterior nasal swab specimens obtained from individuals, who are suspected of 
respiratory viral infection within five (5) days of symptom onset.  This test is intended for non-
prescription home use with self-collected direct anterior nares swab samples from individuals 
ages 14 years and older or adult lay user collected anterior nares swab samples from individuals 
aged 2 to 13 years.  The performance characteristics of the test using nasal swabs have not been 
established.  The results obtained from this study will not be used for diagnostic purposes or 
patient management.  
Results are intended for the simultaneous identification of SARS-CoV-2, influenza A, and/or 
influenza B, which are generally detectable in nasal samples during the acute phase of infection.  
Positive results indicate the presence of viral antigens, but clinical correlation with patient 
history and other diagnostic information is necessary to determine infection status.  Positive 
results do not rule out bacterial infection or co-infection with other viruses.  The agent detected 
may not be the definite cause of disease. 
1.7 
Study Sites 
Study enrollment for this study will be conducted at one (1) testing site in the US.  The site will 
attempt to enroll a diverse demographic patient population with varying educational 
backgrounds.   
The applicable Institutional Review Board (IRB) will review and approve the study protocol, 
informed consent and assent, Quick Reference Instructions (QRI), and subject questionnaire and 
test illustrations prior to enrolling subjects into this study. 
1.8 
Study Objectives  
The objective of this protocol is to determine the usability of the MGC Health COVID-19 & Flu 
A+B Home Multi Test in a simulated home use environment. 
1.9 
Study Design 
This is an open label observational study to evaluate the usability of the MGC Health COVID-19 
& Flu A+B Home Multi Test. 
Each subject will be provided a MGC Health COVID-19 & Flu A+B Home Multi Test and asked 
to conduct the test on themselves or another subject using the Quick Reference Instructions 
(QRI) for the MGC Health COVID-19 & Flu A+B Home Multi Test while being monitored by 
an observer.   

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A member of the clinical study staff will observe the subject while they are conducting the test. 
The observer will note the completion and/or correct performance of critical steps which, if not 
performed correctly, could lead to an inaccurate test result.   
The observer will note whether or not they agree with the subject’s interpretation of the test 
results.  A photograph of the test cartridge will be taken showing the results. 
 Subjects will be asked to provide their perspective on the use of the test at the end of the testing 
process. 
In addition, a set of illustrations of test results will be provided to each subject for interpretation. 
Results of the testing will be used to determine whether further refinement of the QRI may be 
needed.  The results of the testing will not be used for patient management or treatment 
decisions. 
2 STUDY ENROLLMENT AND WITHDRAWAL 
2.1 
Study Population 
Enrollment must include 15 subjects ages 14 and older, and 15 subjects ages 2-13 who present to 
the office location for COVID-19 and/or flu testing.  The intent is to enroll subjects with varying 
educational levels and socioeconomic backgrounds. 
2.2 
Enrollment Criteria 
Subjects are eligible for enrollment only if all of the inclusion criteria are met and none of the 
exclusion criteria apply. 
2.2.1 
Inclusion Criteria  
1. An Institutional Review Board (IRB) approved informed consent / assent, if applicable, is 
signed and dated prior to any study-related activities. 
2. Males and females ages 2 and older. 
3. Subject is willing to provide a self-collected nasal swab sample. (If the subject is under 
the age of 14, an adult lay-user will collect the sample.) 
4. Subject agrees to complete all aspects of the study. 
2.2.2 
Exclusion Criteria 
1. Subject has a visual impairment that cannot be restored with glasses or contact lenses. 
2. Subject has prior medical or laboratory training. 
3. Subject uses home diagnostics, e.g., glucose meters, HIV tests. 
4. Subject has prior knowledge of their current COVID-19 or flu infection status. 

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2.3 
Study Duration  
The overall study duration is expected to be less than one (1) month, with subject participation 
completed in one visit of approximately one hour. 
2.4 
Subject Withdrawal 
Subjects may discontinue their participation in the study at any time.  A subject may be 
withdrawn from the study at any time at the discretion of the investigator. 
A subject may be considered withdrawn for the purpose of this study if: 
• The subject or parent / legal guardian of the subject withdraws consent for study 
participation 
• The subject is non-compliant with study procedures 
• The investigator determines to withdraw the subject if study participation is no longer in 
the subject’s best interest. 
3 STUDY PROCEDURES  
3.1 
Set Up 
Testing will take place in a room to simulate the home environment.  A table with chairs will be 
available.  The observer will stand or sit to the side of the subject providing enough space to: 1) 
ensure there is no interference with the subject’s activities and 2) allow adequate view of the 
subject’s interaction with the test kit.  Other than providing the test kit and QRI, the observer will 
not provide any other directions on how to use the kit. 
Each box of the MGC Health COVID-19 & Flu A+B Home Multi Test contains one (1) each of 
the following: sterile nasal swab, test cassette, and the sample collection tube with nozzle lid.    
Upon completion of the testing, the used test components will be disposed of properly per local 
regulations. 
At the conclusion of testing and the subject’s completion of the questionnaire, the observer will 
present ten (10) images of different test results and ask the subject to interpret each test result.   
3.2 
Informed Consent 
Study staff trained in basic human research subjects protection will explain the study protocol, 
procedures, and objectives to the subject and obtain written informed consent and assent, if 
applicable, for participation in the study from each subject prior to performing any study 
procedures.  The study staff will review all information in the consent / assent, if applicable, 
allowing subjects ample time to review the form(s), ask questions and have their questions 
answered to the satisfaction of the subject.  Subjects willing to participate will sign the consent / 
assent, if applicable, and will be provided a copy for their records.   

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3.2.1 
Vulnerable Populations 
The study will be conducted in accordance with the relevant articles of the Declaration of 
Helsinki.  The Declaration of Helsinki defines vulnerable individuals as having “An increased 
likelihood of being wronged or of incurring additional harm.” (World Medical Association 2013)  
For the purpose of this study, we define vulnerable individuals as those whose capacity to protect 
or exercise their rights is restricted due to their mental, social, economic, or ethnical status, age, 
or health condition. Subjects deemed vulnerable by the IRB and/or the principal investigator will 
not be eligible for this study.  
This study involves children who have not attained the legal age for consent to treatment or 
procedures involved in research and are a vulnerable population.  Children are a group already 
burdened by COVID-19 and flu and while there is no benefit to study participants, the anterior 
nares swabs for this study does not pose greater than a minimum risk to children.   
3.3 
Subject Enrollment 
Once informed consent is obtained, the subject will be assigned a subject ID number.  The 
subject ID number will consist of the study site number followed by a 3-digit sequentially 
assigned subject number.  For example, the first subject enrolled at site 01 will be assigned 01-
001, with subsequent enrolled subjects assigned 01-002, 01-003, etc.  The site will maintain an 
enrollment log that correlates the subject ID number to the subject’s name. 
The unique subject ID number will be written on each page of the Case Report Form (CRF) and 
all other documentation related to the subject.  All data will be captured on the paper CRF. 
3.4 
Baseline Data 
The site will provide a narrative describing how the testing simulated a home environment.  For 
example, whether a table and chair were provided, how subjects could sanitize their hands, 
positioning of the subject such that they could not observe others conducting the test, and 
position of the observer. 
Upon confirmation of eligibility to participate in the study, the following information will be 
obtained: 
• Age (For subjects under 14 years of age, the age of the person collecting and testing the 
sample will also be recorded.) 
• Sex 
• Race 
• Ethnicity 
• Educational Level (For subjects under 14 years of age, the educational level of the person 
performing the test will be recorded.)  

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• Occupation (For subjects under 14 years of age, the occupation of the person performing 
the test will be recorded.)  
• Exposure to someone with COVID-19, and the number of days prior to the visit the 
exposure occurred. 
• Presence or absence of respiratory symptoms: fever or chills; cough; shortness of breath; 
difficulty breathing; muscle or body aches, new loss of taste or smell.  Subjects will be 
asked the date each symptom appeared. 
• COVID-19 vaccine status and number of doses, manufacturer, and date of last vaccine. 
• Flu vaccine status and date of vaccine, if applicable. 
3.5 
Test Procedure 
The observer will provide the subject the MGC Health COVID-19 & Flu A+B Home Multi 
Test and the QRI.  The lot number and expiration date of the kit will be recorded.  The 
observer will ask the subject to conduct the test.  The subject will be expected to collect the 
sample, conduct the test, read and interpret the test result. 
The observer will complete an observation form that will assess how well the subject 
followed the QRI to perform the critical steps for the test and interpret the test result.   
The critical steps that each subject should perform accurately are as follows: 
• Swab each nostril, rotating swab against nostril at least 5 times. 
• Rotate the nasal swab in the sample collection tube liquid at least 5 times. 
• Lift the swab out of the liquid in the collection tube and squeeze the tube against the 
swab tip 3 times. 
• Squeeze the sample collection tube while removing the nasal swab. 
• Press the nozzle lid firmly onto the sample collection tube. 
• Transfer 3 drops from the sample collection tube into the sample well of test cassette. 
• Do not move or lift the test cassette. 
• Read the results between 15 and 20 minutes. 
The subjects will interpret the test result and the observer will assess whether they agree or 
do not agree with the reading of the result.  If they do not agree, they will provide the reason. 
The observer will label each cartridge with the subject ID, protocol number, and date and 
will take a photograph of each test cartridge immediately after the subject has interpreted the 
result.  Each photograph will be saved as an image titled with the subject’s ID number.   
After completion of the test process, the subject will complete a questionnaire on the clarity 
of the instructions provided, ease of performing the test, and ease of reading and interpreting 
their results.  

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The subjects will then be presented with 10 sample images of test results (1 negative, 7 
positive, and 2 invalid) to confirm their ability to use the QRI to read and interpret all 
possible test results. The provided images will be as follows:  
Image 1 - invalid test (no lines);  
Image 2 – positive Flu A 
Image 3 – positive COVID-19, Flu A, and Flu B 
Image 4 – invalid test (Flu A line, no C line) 
Image 5 – positive Flu B 
Image 6 – positive Flu A, and Flu B 
Image 7 - negative 
Image 8 – positive COVID-19 and Flu A 
Image 9 – positive COVID-19 and Flu B 
Image 10 – positive COVID-19 
The observer will record the subject’s interpretation of the sample test results in the CRF. 
Participation in the study should be completed in under one hour. 
4 PREMATURE STUDY TERMINATION OR SUSPENSION 
4.1 
Termination or Suspension 
This study may be suspended or prematurely terminated by the sponsor or the investigator 
immediately upon notice for any cause. Written notification via email or post, documenting the 
reason for study suspension or termination, will be provided by the suspending, or terminating 
party. If the study is prematurely terminated or suspended, the principal investigator will 
promptly inform the IRB and will provide the reason(s) for suspension or termination. 
4.2 
Circumstances Warranting Termination or Suspension 
Circumstances that may warrant termination include, but are not limited to: 
1. Insufficient adherence to protocol requirements. 
2. Data that are not sufficiently complete and/or evaluable. 

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3. Determination of futility 
5 SAFETY CONSIDERATIONS  
5.1 
Safety Warnings and Precautions 
All samples should be handled as potentially infectious.  Use an appropriate disinfectant for 
decontamination.  Store and dispose of these materials and their containers in accordance with 
local regulations and guidelines. 
5.2 
Definition of Adverse Events 
An Adverse Event (AE) is any untoward medical event that occurs to the subject during the 
course of a study (with onset after the first study-specific procedure), whether or not that event is 
considered study-related.  
An adverse event may be mild, moderate, or severe and is usually unexpected. 
All adverse events observed by the principal investigator or reported by the subject must be 
reported to the sponsor within 24 hours.  To report an adverse event, the principal investigator 
will complete an adverse event form or relevant form located in the CRF. 
Adverse events will be considered study-related if the event follows a reasonable temporal 
sequence from a study related procedure and could readily have been produced by that study 
procedure. For the purpose of this study, only the collection of nasal nares swab is considered to 
be the study procedure. 
5.3 
Reporting of Serious Adverse Events  
A Serious Adverse Event (SAE) is any adverse event that: 
• led to death 
• led to a serious deterioration in the health of the subject that either resulted in a life-
threatening illness or injury, or a permanent impairment of a body structure or a body 
function, or in-patient hospitalization or prolongation of existing hospitalization, or in 
medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function 
• led to fetal distress, fetal death, or a congenital abnormality or birth defect 
Hospitalization is defined as greater than 24 hours in hospital. 
All serious adverse events must be reported to the sponsor by telephone within 24 hours of the 
principal investigator becoming aware of it.   

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The sponsor will be contacted using the following information: 
Contact Name: 
Tomaz Lovse 
Telephone Number:  239-631-1907 
The principal investigator should institute appropriate therapeutic and follow-up measures in 
accordance with good medical practice but should notify the monitor of such actions and record 
them in the subject’s CRF.  Each telephone reported reaction must be reported in writing to the 
sponsor within 10 working days of the event.  
It is also the responsibility of the principal investigator to inform the representative of the 
appropriate local IRB in a timely manner. 
5.4 
Possible Risks Associated with Study Procedures 
The only study-related procedure that could impact subject safety is in the collection of a direct 
anterior nares (nasal) swab.  The risks of collecting a nasal nares swab may include symptoms 
associated with standard collection practices such as slight pain and/or minor bleeding.   
Information collected for this study is confidential. Subjects will be identified using a study 
specific number at the time of enrollment.  All study forms will be labeled with the study 
number.  No identifiable patient information will be provided to the sponsor. However, officials 
of the FDA or other regulatory agencies may research records during the ordinary course of 
conducting their functions. A sponsor representative may also inspect research records to make 
certain the study data is accurate.  The investigator, institution, regulatory agencies, and the 
sponsor will protect the confidentiality of the records. 
No medical decisions will be based on investigational assay results generated as part of the 
study. 
6 REGULATORY AND ADMINISTRATIVE REQUIREMENTS  
6.1 
Good Clinical Practice 
The investigator will ensure that this study is conducted in full compliance with the principles of 
the “Declaration of Helsinki” (as amended in Edinburgh, Tokyo, Venice, Hong Kong, and South 
Africa), International Council for Harmonization of Technical Requirements for Pharmaceuticals 
for Human Use guidelines, or with the laws and regulations of the country in which the research 
is conducted, whichever affords the greater protection to the study subject.  For studies 
conducted under a United States investigational new drug application, the investigator will 
ensure that the basic principles of “Good Clinical Practice (GCP),” as outlined in 21 CFR 312, 
subpart D, “Responsibilities of Sponsors and Investigators,” 21 CFR, part 50, 1998, and 21 CFR, 
part 56, 1998, are adhered to.  This study is also subject to and will be conducted in compliance 

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with 21 CFR, part 320, 1993, “Retention of Bioavailability and Bioequivalence Testing 
Samples.” 
6.2 
Responsibility of Investigator  
The principal investigator is responsible for the proper conduct of the study at their site(s).  The 
investigator will ensure that the study is conducted in compliance with the protocol, the Clinical 
Study Agreement, and applicable regulations in 45 CFR 46, and any other applicable regulatory 
requirements.  These requirements include:  
• Obtaining IRB approval for the study and related documents before study initiation 
enrolling subjects. 
• Obtaining informed consent from each subject in accordance with 21 CFR Part 50, as 
applicable. 
• Protecting the rights, safety, and welfare of subjects under their care. 
• Reporting adverse events. 
• Coordinating and providing reasonable medical care to subjects for an adverse event 
related to study participation. 
• Reporting protocol deviations to the sponsor and IRB per IRB requirements. 
• Maintaining traceability and secured storage of all test kits and study samples. 
• Ensuring confidentiality of all study documents, procedures, and study samples. 
6.3 
Sponsor Responsibility  
The sponsor has the overall responsibility for the conduct of the study, including assurance that 
the study meets regulatory requirements as applicable.   
The sponsor’s study-related duties and functions may be transferred to a contract research 
organization (CRO). 
6.4 
Protocol Deviations 
A protocol deviation is a failure to comply with the requirements specified within the clinical 
study protocol or IRB requirements. Investigators are not allowed to deviate from the protocol 
except when a deviation is necessary to protect a subject’s rights and well-being, or the scientific 
integrity of the study. 

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6.5 
Changes to Protocol 
In the event the study protocol is amended, the monitor will provide the principal investigator 
with the protocol amendment(s) and a revised protocol. 
Protocol amendments that affect the subjects’ rights or safety must be submitted to and approved 
by the IRB.  
6.6 
Reconciliation of Study Material, Supplies and Samples 
The sponsor will supply sufficient quantities of study materials and supplies to enable the site to 
complete the study.  The site will return all unused materials and supplies to the sponsor or will 
dispose of unused materials and supplies, according to provided instructions. The site is required 
to maintain the inventory of the materials provided and will document the reconciliation of these 
materials. If materials are disposed of at the study site, the investigator must provide the sponsor 
with a signed record of disposition. 
7 STATISTICAL CONSIDERATIONS 
Except where otherwise specified, the following general principles apply to the planned 
statistical analyses. All statistical analysis will be conducted using a current version 9.4 (or later) 
of SAS (SAS Institute Inc., Cary, NC), Excel version 2010 or later, or other widely accepted 
statistical or graphical software as required.  Categorical variables (e.g., sex) will be summarized 
with frequency counts and percentages. 
7.1 
Usability Study and Risk Mitigation for User Errors 
The results will be analyzed to confirm the proper use of the QRI and usability of the MGC 
Health COVID-19 & Flu A+B Home Multi Test.  The usability of the MGC Health COVID-19 
& Flu A+B Home Multi Test will be considered valid if: 
• The mean score of the subjects’ response scores in the questionnaire are ≤ 3 for those 
questions with a score response between 1 and 5. 
• 80% of the critical steps were performed correctly based upon the observer’s assessment.   
• 80% of the interpretation of the sample image results were correct.  
The subject questionnaires and observer notes will be used to modify the QRI, if necessary, and 
additional usability testing will be conducted if needed. 

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8 ETHICAL CONSIDERATIONS 
The investigator and site study staff will be responsible for the ethical conduct of this study in 
accordance with 45 CFR 46, 21 CFR 50, 21 CFR 56 governing IRB review and informed 
consent. 
8.1 
Institutional Review Board 
The participating site must provide for review and approval of this protocol and associated 
informed consent by an appropriate IRB. Any amendments to the protocol or consent materials 
must also be reviewed and approved by the IRB prior to use. 
Prior to study initiation, the Institutional Review Board (IRB) responsible for the studies to be 
conducted at the site must provide written approval of the protocol and informed consent. The 
investigator will provide IRB documentation for all applicable IRB submissions to the sponsor. 
If IRB approval is withdrawn, the investigator will immediately report this to the sponsor. 
8.2 
Informed Consent Process 
Informed consent is a process that is initiated prior to the potential subject’s agreement to 
participate in the study and continues throughout the study participation.  The principal 
investigator must explain to each potential subject the nature of the clinical study, including any 
risks and benefits, its purpose, and procedures, and expected duration of involvement in the 
clinical study.  Each potential subject must be informed that participation in the clinical study is 
voluntary and non-participation will not affect his / her right to the most appropriate treatments 
or affect the doctor/clinician-patient relationship.  Each potential subject must be given sufficient 
time to decide whether they wish to participate and have all their queries addressed prior to 
signing the IRB-approved consent form(s).  A copy of the signed consent form(s) must be 
provided to the potential subject.  Study specific procedures will not be initiated until the 
potential subject has signed and dated the appropriate consent form(s).  Subjects have full rights 
to withdraw from the clinical study at any time, irrespective of their initial consent.  
Each potential subject must also give their permission for representatives of the sponsor, auditor, 
and regulatory authorities to review their hospital records for the purposes of source data 
verification. 
Written informed consent from the potential subject must be obtained before any clinical 
investigation related procedures are performed.  
8.3 
Subject Confidentiality 
Confidentiality of subject data will be maintained at all times.  Subject anonymity will be 
guaranteed and all documentation relating to a subject will be kept in a secure location. 

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Study documents provided to the sponsor will be stored in a secure location with access.  None 
of the stored documents will contain any personal identifying information or direct identifiers. 
Study files will be made available to the IRB, regulatory authorities, sponsor (or designee) 
and/or clinical study staff should they request access for auditing purposes.  
9 DATA MANAGEMENT 
The investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness 
of the data reported.  All data collection should be completed in a neat, legible manner to ensure 
the accurate interpretation of data. 
9.1 
Data Management Responsibilities 
Data collection and accurate documentation are the responsibility of the study staff under the 
supervision of the investigator. Data must be recorded using black ink and any changes or 
corrections made must be done by drawing a single line through the original entry.  The 
corrected entry must be initialed and dated by the individual making the corrections. DO NOT 
ERASE, OVERWRITE, OR USE CORRECTION FLUID OR TAPE ON THE ORIGINAL.  
The investigator or designee must review unanticipated problems. 
9.2 
Study Records Retention  
The principal investigator will retain all copies of the records as directed by the sponsor for a 
period of at least 2 years after the latter of the following two dates: the date on which the study is 
terminated or completed, or the date the declaration of emergency is rescinded. In all cases, the 
principal investigator must obtain written consent from the sponsor prior to disposing of any 
records related to the clinical study.  
10 LITERATURE REFERENCES 
1. Template for Developers of Molecular and Antigen Diagnostic COVID-19 Test for 
Home Use. Version October 6, 2021 
2. Supplemental Template for Developers of Molecular and Antigen Diagnostic COVID-19 
Tests for Screening with Serial Testing. Version October 6, 2021 
3. World Medical Association. World Medical Association Declaration of Helsinki: ethical 
principles for medical research involving human subjects. JAMA. 2013 Nov 
27;310(20):2191-4. doi: 10.1001/jama.2013.281053. PMID: 24141714. 
4. Atchison C, Pristera P, Cooper E et al. Usability and Acceptability of Home-based Self-
testing for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) 
Antibodies for Population Surveillance. CID 2021:72 (1 May) 

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11 SUBJECT QUESTIONNAIRE 
The following questionnaire will be presented to subjects after completion of the MGC Health 
COVID-19 & Flu A+B Home Multi Test. 
Subject Questions 
1. Overall, how easy or difficult was it to understand the instructions to conduct the test? 
1. Very easy to understand 
2. Fairly easy to understand 
3. Easy 
4. Fairly difficult to understand 
5. Very difficult to understand 
 
2. How easy or difficult was it to open the test cassette package? 
1. Very easy  
2. Fairly easy  
3. Easy 
4. Fairly difficult  
5. Very difficult  
3. How easy or difficult was it to remove the sealed film covering from the sample 
collection tube? 
1. Very easy  
2. Fairly easy  
3. Easy 
4. Fairly difficult  
5. Very difficult  

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4. How easy or difficult was it to understand the instructions on how to collect the 
sample from your nose or from another person? 
1. Very easy to understand 
2. Fairly easy to understand 
3. Easy 
4. Fairly difficult to understand 
5. Very difficult to understand 
5. How easy or difficult was it to understand the instructions to swirl the swab in the 
collection tube? 
1. Very easy to understand 
2. Fairly easy to understand 
3. Easy 
4. Fairly difficult to understand 
5. Very difficult to understand  
6. How easy or difficult was it to understand the instructions on how to lift the swab out 
of the liquid and squeeze the collection tube? 
1. Very easy  
2. Fairly easy  
3. Easy 
4. Fairly difficult 
5. Very difficult  
 
 
 

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7. How easy or difficult was it to insert the nozzle lid onto the sample collection tube? 
1. Very easy  
2. Fairly easy  
3. Easy 
4. Fairly difficult  
5. Very difficult 
8. How easy or difficult was it to understand the instructions to add the sample from the 
collection tube to the sample well of the test cassette? 
1. Very easy to understand 
2. Fairly easy to understand 
3. Easy 
4. Fairly difficult to understand 
5. Very difficult to understand 
 
9. How easy or difficult was it to add the 3 drops into the test cassette? 
1. Very easy  
2. Fairly easy  
3. Easy 
4. Fairly difficult  
5. Very difficult  
 

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10. How easy or difficult was it to read the test results? 
1. Very easy 
2. Fairly easy 
3. Easy 
4. Fairly difficult 
5. Very difficult 
 
11. How easy or difficult was it to understand the instructions on how to interpret the 
results of the test? 
1. Very easy to understand 
2. Fairly easy to understand 
3. Easy 
4. Fairly difficult to understand 
5. Very difficult to understand 
 
Additional Comments: