Prospective Clinical Evaluation of COVID/Flu Detect™ Rapid Self-Test in Symptomatic Subjects for Non-Prescription Over-the-Counter (OTC) Use

CompletedOBSERVATIONAL
Enrollment

899

Participants

Timeline

Start Date

December 26, 2024

Primary Completion Date

May 19, 2025

Study Completion Date

May 19, 2025

Conditions
COVID-19Influenza AInfluenza B
Interventions
DIAGNOSTIC_TEST

COVID/Flu Detect™ Rapid Self-Test

The COVID/Flu Detect™ Rapid Self-Test is an investigational qualitative lateral flow immunoassay designed for the detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens in nasal swab samples. It is intended for non-prescription over-the-counter (OTC) use.

Trial Locations (10)

10029

Ichan School of Medicine at Mount Sinai, Department of Emergency Medicine, New York

10455

CHEAR Center LLC., The Bronx

33135

Medicus Health Research Group Inc, Miami

35242

Cahaba Research, Birmingham

63110

Barnes-Jewish Hospital, St Louis

St. Louis Children's Hospital, St Louis

Washington University School of Medicine, St Louis

79707

Eastside Research Associates, Midland

79762

ERA Health Research, Odessa

83702

ASR, LLC, Boise

Sponsors
All Listed Sponsors
lead

InBios International, Inc.

INDUSTRY