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

NCT05334758 | Completed Results FDA Device

• 1 other identifier: BTK-01-1002
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 3

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.

Conditions

COVID-19

Keywords

Covid, Covid 19, Virus

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

At least 30 children between 2 - 13 years of age

EXPERIMENTAL

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; Device: Standard of Care COVID-19 Test; Diagnostic Test: RT-PCR Test

Subjects 14 - 90 years of age

EXPERIMENTAL

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; Device: Standard of Care COVID-19 Test; Diagnostic Test: RT-PCR Test

Interventions

Bio-Self COVID-19 Antigen Home Test DEVICE

At home COVID-19 antigen test kit

At least 30 children between 2 - 13 years of age; Subjects 14 - 90 years of age

Standard of Care COVID-19 Test DEVICE

Standard of care

At least 30 children between 2 - 13 years of age; Subjects 14 - 90 years of age

RT-PCR Test DIAGNOSTIC_TEST

High Sensitivity RT-PCR COVID-19 Test

At least 30 children between 2 - 13 years of age; Subjects 14 - 90 years of age

Eligibility Criteria

• Age: 2 Years - 94 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioTeke USA, LLC: lead
• CSSi Life Sciences: collaborator

Study Sites (3)

L&A Morales Healthcare, Inc.

Miami, Florida, 33142, United States

Location

CDR Health

Tallahassee, Florida, 32308, United States

Location

Centennial Medical

Elkridge, Maryland, 21075, United States

Location

MeSH Terms

Conditions

COVID-19; Virus Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Chang Turkmani
• Organization: BioTeke USA

chang@themegaco.com

202-679-2112

Study Officials

• Steven Geller, MD

  Centennial Medical Group

  PRINCIPAL INVESTIGATOR

• Enrique Villa, MD

  L&A Morales Healthcare

  PRINCIPAL INVESTIGATOR

• Narendra Kini, MD

  CDR Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 \[(NPA) specificity\].

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 19, 2022
• Study Start: May 12, 2022
• Primary Completion: July 25, 2022
• Study Completion: July 25, 2022
• Last Updated: March 12, 2024
• Results First Posted: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)