Back to results

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

Primary Purpose

COVID-19

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Bio-Self COVID-19 Antigen Home Test

Standard of Care COVID-19 Test

RT-PCR Test

About this trial

This is an interventional diagnostic trial for COVID-19 focused on measuring Covid, Covid 19, Virus

Eligibility Criteria

2 Years - 94 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

L&A Morales Healthcare, Inc.
CDR Health
Centennial Medical

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

At least 30 children between 2 - 13 years of age

Subjects 14 - 90 years of age

Arm 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.

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.

Outcomes

Primary Outcome Measures

Positive Percent Agreement

comparison between the Bio-Self Test and the RT-PCR Test results

Negative Percent Agreement

comparison between the Bio-Self Test and the RT-PCR Test results

Secondary Outcome Measures

Full Information

NCT ID

NCT05334758

First Posted

April 15, 2022

Last Updated

July 25, 2023

Sponsor

BioTeke USA, LLC

Collaborators

CSSi Life Sciences

1. Study Identification

Unique Protocol Identification Number

NCT05334758

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

May 12, 2022 (Actual)

Primary Completion Date

July 25, 2022 (Actual)

Study Completion Date

July 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BioTeke USA, LLC

Collaborators

CSSi Life Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

Covid, Covid 19, Virus

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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].

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

282 (Actual)

8. Arms, Groups, and Interventions

Arm Title

At least 30 children between 2 - 13 years of age

Arm Type

Experimental

Arm Description

Arm Title

Subjects 14 - 90 years of age

Arm Type

Experimental

Arm 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.

Intervention Type

Device

Intervention Name(s)

Bio-Self COVID-19 Antigen Home Test

Intervention Description

At home COVID-19 antigen test kit

Intervention Type

Device

Intervention Name(s)

Standard of Care COVID-19 Test

Intervention Description

Standard of care

Intervention Type

Diagnostic Test

Intervention Name(s)

RT-PCR Test

Intervention Description

High Sensitivity RT-PCR COVID-19 Test

Primary Outcome Measure Information:

Title

Positive Percent Agreement

Description

comparison between the Bio-Self Test and the RT-PCR Test results

Time Frame

48 hours

Title

Negative Percent Agreement

Description

comparison between the Bio-Self Test and the RT-PCR Test results

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

94 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Geller, MD

Organizational Affiliation

Centennial Medical Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

L&A Morales Healthcare, Inc.

City

Miami

State/Province

Florida

ZIP/Postal Code

33142

Country

United States

Facility Name

CDR Health

City

Tallahassee

State/Province

Florida

ZIP/Postal Code

32308

Country

United States

Facility Name

Centennial Medical

City

Elkridge

State/Province

Maryland

ZIP/Postal Code

21075

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs