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

NCT06734741 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 899

Last updated 2025-05-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • InBios International, Inc.

    lead INDUSTRY

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-26
Primary Completion
2025-05-19
Completion
2025-05-19
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 NCT06734741 on ClinicalTrials.gov