MedTrace Logo

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

NCT05334758 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2024-03-12

Study results available
· View outcomes & findings →

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

Interventions

DEVICE

Bio-Self COVID-19 Antigen Home Test

At home COVID-19 antigen test kit

DEVICE

Standard of Care COVID-19 Test

Standard of care

DIAGNOSTIC_TEST

RT-PCR Test

High Sensitivity RT-PCR COVID-19 Test

Sponsors & Collaborators

  • CSSi Life Sciences

    collaborator INDUSTRY

  • BioTeke USA, LLC

    lead INDUSTRY

Principal Investigators

  • Steven Geller, MD · Centennial Medical Group

  • Enrique Villa, MD · L&A Morales Healthcare

  • Narendra Kini, MD · CDR Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
94 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-12
Primary Completion
2022-07-25
Completion
2022-07-25
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05334758 on ClinicalTrials.gov