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

Not Applicable

Completed

• Conditions: COVID-19
• Interventions: Device: Bio-Self COVID-19 Antigen Home Test; Device: Standard of Care COVID-19 Test; Diagnostic Test: RT-PCR Test

• Registration Number: NCT05334758
• Lead Sponsor: BioTeke USA, LLC

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.

Study Timeline

• Study First Submitted: 2022-04-15
• Study First Submitted QC: 2022-04-15
• Study First Posted: 2022-04-19
• Study Start: 2022-05-12
• Primary Completion: 2022-07-25
• Study Completion: 2022-07-25
• Results First Submitted: 2024-02-12
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-11
• Last Update Submitted: 2024-03-11
• Results First Posted: 2024-03-12
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects 14 - 90 years of age	Bio-Self COVID-19 Antigen Home Test	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.
Subjects 14 - 90 years of age	RT-PCR Test	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.
At least 30 children between 2 - 13 years of age	RT-PCR Test	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.
Subjects 14 - 90 years of age	Standard of Care COVID-19 Test	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.
At least 30 children between 2 - 13 years of age	Bio-Self COVID-19 Antigen Home Test	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.
At least 30 children between 2 - 13 years of age	Standard of Care COVID-19 Test	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.

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.

Trial Locations

Locations (3)

CDR Health; 🇺🇸 Tallahassee, Florida, United States

L&A Morales Healthcare, Inc.; 🇺🇸 Miami, Florida, United States

Centennial Medical; 🇺🇸 Elkridge, Maryland, United States