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

BioTeke

Status: Completed

Conditions: COVID-19

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05334758

BTK-01-1002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 282 patients

Sex: All

Ages: 2 to 94 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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282 participants in 2 patient groups

At least 30 children between 2 - 13 years of age

Experimental group

Description:

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.

Treatment:

Device: Standard of Care COVID-19 Test

Diagnostic Test: RT-PCR Test

Device: Bio-Self COVID-19 Antigen Home Test

Subjects 14 - 90 years of age

Experimental group

Description:

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.

Treatment:

Device: Standard of Care COVID-19 Test

Diagnostic Test: RT-PCR Test

Device: Bio-Self COVID-19 Antigen Home Test