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

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Positive Percent Agreement - Sensitivity	48 hours	The sensitivity is computed as the proportion of positive samples as called by the EUA SARS-CoV-2 RT-PCR assay, which are also positive as called by the Bio-Self COVID-19 Antigen Home Test.
Negative Percent Agreement - Specificity	48 hours	The specificity is computed as the proportion of negative samples as called by the EUA SARS-CoV-2 RT-PCR assay, which are also negative as called by the Bio-Self COVID-19 Antigen Home Test.

Secondary Outcome Measures

Name	Time	Method

Locations (3): L&A Morales Healthcare, Inc.
🇺🇸
Miami, Florida, United States
CDR Health
🇺🇸
Tallahassee, Florida, United States
Centennial Medical
🇺🇸
Elkridge, Maryland, United States
L&A Morales Healthcare, Inc.
🇺🇸Miami, Florida, United States