Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the performance of the Bio-Self COVID-19 Antigen Home Test. The study will evaluate the accuracy (sensitivity and specificity) in a simulated home use environment when compared to a high-sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assay.

Detailed Description
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The Bio-Self COVID-19 Antigen Home Test is immunochromatographic and uses double-antibody sandwich method to detect SARS-CoV-2 antigen from individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection. The 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 collected anterior nares swab samples from individuals ages 2 to 13. The primary objective of this study is to determine the accuracy of the Bio-Self COVID-19 Antigen Home Test when compared to a high-sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assay.

Official Title
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Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test

Conditions
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COVID-19

Intervention / Treatment
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* Device: Bio-Self COVID-19 Antigen Home Test
* Device: Standard of Care COVID-19 Test
* Diagnostic Test: RT-PCR Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: An Institutional Review Board (IRB) approved informed consent and assent, if applicable, is signed and dated prior to any study-related activities. Male and female Subjects 2 years of age and older. Subject is willing to provide a self-collected nasal swab sample. (If under the age of 14, the sample will be collected by an adult.) Subject is willing to have a nasal swab collected by a healthcare professional. Subject agrees to complete all aspects of the study. Exclusion Criteria: Subject has a visual impairment that cannot be restored with glasses or contact lenses. Subject has prior medical or laboratory training. Subject had a positive COVID-19 test in past three (3) months. Subject uses home diagnostics, e.g., HIV Tests, glucose meters, etc.

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

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This is an open label, prospective study to evaluate the sensitivity and specificity of the Bio-Self COVID-19 Antigen Home Test when a lay person conducts the test on themselves or another study participant. Potential subjects will be those presenting for COVID-19 testing. The study will evaluate the performance of the Bio-Self COVID-19 Antigen Home Test by comparing it to a high sensitivity EUA SARS-CoV-2 RT-PCR assay to calculate both the positive percent agreement [(PPA) sensitivity] and negative percent agreement [(NPA) specificity].
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: At least 30 children between 2 - 13 years of age<br>Subjects less than 14 years of age, where the Parent or legal guardian collects a sample from their child (e.g., ages 2-13) and performs the Bio-Self COVID-19 antigen home test. The standard of care test and the RT-PCR test samples will be collected by the study team. | Device: Bio-Self COVID-19 Antigen Home Test<br>* At home COVID-19 antigen test kit<br>Device: Standard of Care COVID-19 Test<br>* Standard of care<br>Diagnostic Test: RT-PCR Test<br>* High Sensitivity RT-PCR COVID-19 Test<br>|
| Experimental: Subjects 14 - 90 years of age<br>The subject will self collect and test using the Bio-Self COVID-19 antigen home test. The standard of care test and the RT-PCR test samples will be collected by the study team. | Device: Bio-Self COVID-19 Antigen Home Test<br>* At home COVID-19 antigen test kit<br>Device: Standard of Care COVID-19 Test<br>* Standard of care<br>Diagnostic Test: RT-PCR Test<br>* High Sensitivity RT-PCR COVID-19 Test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Percent Agreement | comparison between the Bio-Self Test and the RT-PCR Test results | 48 hours | 
| Negative Percent Agreement | comparison between the Bio-Self Test and the RT-PCR Test results | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid, Covid 19, Virus