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

Purpose

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.

Condition

  • COVID-19

Eligibility

Eligible Ages
Between 2 Years and 94 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. An Institutional Review Board (IRB) approved informed consent and 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 under the age of 14, the sample will be collected by an adult.) 4. Subject is willing to have a nasal swab collected by a healthcare professional. 5. Subject agrees to complete all aspects of the study.

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 had a positive COVID-19 test in past three (3) months. 4. Subject uses home diagnostics, e.g., HIV Tests, glucose meters, etc.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Intervention 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].
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
At least 30 children between 2 - 13 years of age 		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
    At home COVID-19 antigen test kit
  • Device: Standard of Care COVID-19 Test
    Standard of care
  • Diagnostic Test: RT-PCR Test
    High Sensitivity RT-PCR COVID-19 Test
Experimental
Subjects 14 - 90 years of age 		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
    At home COVID-19 antigen test kit
  • Device: Standard of Care COVID-19 Test
    Standard of care
  • Diagnostic Test: RT-PCR Test
    High Sensitivity RT-PCR COVID-19 Test

Recruiting Locations

More Details

NCT ID
NCT05334758
Status
Completed
Sponsor
BioTeke USA, LLC

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.