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

NCT06734741 | Completed FDA Device

• 2 other identifiers: COVID-FLU-OTC 2024W81XWH-20-F-0253
• Study Type: observational
• Target: 899
• Locations: 1 country
• Sites: 10

Brief Summary

The goal of this study is to evaluate the performance of the COVID/Flu Detect™ Rapid Self-Test when used in a home-like setting by lay users. The COVID/Flu Detect™ Rapid Self-Test is an investigational device intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens in nasal swab samples. Participants who are aged two (2) years and older and have symptoms of respiratory illness consistent with SARS-CoV-2 and influenza infection may be enrolled. Participants will use the COVID/Flu Detect™ Rapid Self-Test to self-collect, self-test, and interpret the results. Participants will have a nasal swab sample collected by a healthcare provider for comparator testing by PCR tests for SARS-CoV-2, influenza A, and influenza B. Researchers will compare the results of the COVID/Flu Detect™ Rapid Self-Test obtained by the participants to results from the PCR comparator tests to evaluate performance.

Conditions

COVID-19; Influenza A; Influenza B

Outcome Measures

Primary Outcomes (1)

• Positive percent agreement (PPA) and negative percent agreement (NPA) of the COVID/Flu Detect™ Rapid Self-Test

  The primary objective of the study is to evaluate the positive percent agreement (PPA) and negative percent agreement (NPA) of the COVID/Flu Detect™ Rapid Self-Test for SARS-CoV-2, influenza A, and influenza B when used in a home-like setting by symptomatic lay users who are within five (5) days of symptoms onset compared to RT-PCR comparator tests for SARS-CoV-2, influenza A, and influenza B. The comparator tests will include an emergency use authorized (EUA) or FDA-cleared SARS-CoV-2 RT-PCR test and an FDA-cleared influenza A and B RT-PCR test.

  Participant samples will be tested on the COVID/Flu Detect™ Rapid Self-Test on the day of enrollment.

Interventions

COVID/Flu Detect™ Rapid Self-Test DIAGNOSTIC_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.

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will be selected from at least three geographically diverse sites in the United States.

You may qualify if:

• Subjects must be at least 18 years of age, or at least 2 years of age and accompanied by parent or legal guardian.
• Subjects must be willing and able to give informed consent or assent (as age-appropriate).
• Subjects must be able to read/speak English (or Spanish at specific sites) if subject is an adult, minor aged 14 years or older, or parent/guardian of a child subject aged 2 through 13 years.
• Subjects must be currently exhibiting at least two of the following symptoms consistent with possible SARS-CoV-2 or influenza infection: fever or feeling feverish (in absence of documented fever), chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, nasal congestion or runny nose, nausea or vomiting, and/or diarrhea. Subjects must be within 5 days of symptoms onset at enrollment (the day that symptoms start is day 0).

You may not qualify if:

• Subject was previously enrolled in this study.
• Subject has undergone a nasal wash or nasal aspirate procedure on day of enrollment.
• Subject has an active nosebleed.
• Subject has received results of an influenza or COVID-19 test within the previous 5 days.

Sponsors & Collaborators

• InBios International, Inc.: lead

Study Sites (10)

Cahaba Research

Birmingham, Alabama, 35242, United States

Location

Medicus Health Research Group Inc

Miami, Florida, 33135, United States

Location

ASR, LLC

Boise, Idaho, 83702, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

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

New York, New York, 10029, United States

Location

CHEAR Center LLC.

The Bronx, New York, 10455, United States

Location

Eastside Research Associates

Midland, Texas, 79707, United States

Location

ERA Health Research

Odessa, Texas, 79762, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasal swab sample in transport medium collected from study participant by a healthcare provider.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 16, 2024
• Study Start: December 26, 2024
• Primary Completion: May 19, 2025
• Study Completion: May 19, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)