Clinical Performance Evaluation of SARS-CoV-2 (COVID-19) Antigen Assay in Point of Care Settings

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the performance of Freedom For All Diagnostics, Inc.'s colloidal gold immune technology SARS-CoV-2 Antigen investigational assay when compared to a high-sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assay. The study will evaluate the accuracy in the intended use environment of the SARS-CoV-2 antigen assay when testing is conducted in a CLIA-waived setting (e.g., a physician's office or clinic) by non-laboratory personnel serving in a healthcare facility or setting.

Detailed Description
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The objective of this study is to demonstrate that non-laboratory personnel can accurately perform the SARS-CoV-2 Antigen assay in the intended use environment using nasopharyngeal samples by demonstrating that the assay can achieve a ≥ 80% sensitivity when it is compared to the results of a high sensitivity EUA SARSCoV-2 RT-PCR assay using nasopharyngeal samples. This study is designed as a prospective, blinded study to evaluate the sensitivity and specificity of the SARS-CoV-2 Antigen Assay when non-laboratory personnel conduct testing on Subjects presenting with symptoms of COVID-19. A minimum of 30 positive and 30 negative samples are required in order to meet EUA submission guidelines. Enrollment will continue until both minimum requirements have been achieved.

Official Title
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Clinical Performance Evaluation of SARS-CoV-2 Antigen Assay in Point of Care Settings

Conditions
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Covid-19

Intervention / Treatment
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* Device: SARS-CoV-2 Antigen Assay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject suspected of having COVID-19 infection and within 7 days of symptom onset. This will include at least one of the following: Fever or chills Cough Shortness of breath or difficulty breathing Fatigue Muscle or body aches Headache New loss of taste or smell Sore throat Congestion or runny nose In addition to the above primary symptoms, the Subject might also report nausea, vomiting and/or diarrhea, but these symptoms alone are not sufficient to include the Subject in the study. Subject is willing to provide consent/assent. Subject is willing to have two (2) nasopharyngeal swabs collected for the study and in the event of inconclusive results, be willing to return to the site to have two (2) more nasopharyngeal swabs Exclusion Criteria: To be enrolled in the study, each Subject must not meet: Subject unable or unwilling to provide informed consent/assent. Subject tested positive for SARS-CoV-2 within the past 3 months. Subject has already participated in this study. Subject is a vulnerable population and deemed inappropriate for study by site Principal Investigator and/or IRB.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 94 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 30 subjects testing positive for Covid-19<br>30 subjects testing positive for Covid-19 using the proprietary SARS-CoV-2 Antigen Assay | Device: SARS-CoV-2 Antigen Assay<br>* To demonstrate that non-laboratory personnel can accurately perform the SARS-CoV-2 Antigen assay in the intended use environment using nasopharyngeal samples by demonstrating that the assay can achieve a ≥ 80% sensitivity and specificity when it is compared to the results of a high sensitivity EUA SARSCoV-2 RT-PCR assay using nasopharyngeal samples.<br>|
| 30 subjects testing negative for Covid-19<br>30 subjects testing negative for Covid-19 using the proprietary SARS-CoV-2 Antigen Assay | Device: SARS-CoV-2 Antigen Assay<br>* To demonstrate that non-laboratory personnel can accurately perform the SARS-CoV-2 Antigen assay in the intended use environment using nasopharyngeal samples by demonstrating that the assay can achieve a ≥ 80% sensitivity and specificity when it is compared to the results of a high sensitivity EUA SARSCoV-2 RT-PCR assay using nasopharyngeal samples.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assay Sensitivity - 80% (versus the EUA SARS-CoV-2 RT-PCR assay) | SARS-CoV-2 Antigen investigational assay shall have an observed sensitivity of at least 80% when the EUA SARS-CoV-2 RT-PCR assay for nasopharyngeal swabs is used as a reference method. | 48 hours |