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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05334758
• Other study ID #: BTK-01-1002
• Status: Completed
• Phase: N/A
• Start date: May 12, 2022
• Est. completion date: July 25, 2022

Study information

• Verified date: March 2024
• Source: BioTeke USA, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: July 25, 2022
• Est. primary completion date: July 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 94 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Device:
• Bio-Self COVID-19 Antigen Home Test
At home COVID-19 antigen test kit
• Standard of Care COVID-19 Test
Standard of care

Diagnostic Test:
• RT-PCR Test
High Sensitivity RT-PCR COVID-19 Test

Locations

Country	Name	City	State
United States	Centennial Medical	Elkridge	Maryland
United States	L&A Morales Healthcare, Inc.	Miami	Florida
United States	CDR Health	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
BioTeke USA, LLC	CSSi Life Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive Percent Agreement - Sensitivity	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.	48 hours
Primary	Negative Percent Agreement - Specificity	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.	48 hours