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Evaluation of COVID-19 and Flu A/B 3 in 1 Combo Rapid Test

NCT07190131 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 588

Last updated 2026-01-08

No results posted yet for this study

Summary

This observational study aims to evaluate the diagnostic performance of an investigational Influenza A/B and COVID-19 test in patients presenting with signs and symptoms of respiratory infection.

The main questions it aims to answer are:

1. What is the sensitivity and specificity of the investigational test compared with an FDA-cleared reference method for detection of Influenza A, Influenza B, and SARS-CoV-2 antigen.
2. What is the overall positive and negative percent agreement between the investigational test and the reference method?

Participants will:

1. Provide a respiratory specimen (e.g., nasal or nasopharyngeal swab) for testing with the investigational device.
2. Provide an additional specimen for testing with the FDA-cleared reference method.

Conditions

Interventions

DIAGNOSTIC_TEST

Investigational Flu A/B And Covid-19 Diagnostic Test

A diagnostic test in lateral flow cassette format designed to detect Influenza A, Influenza B and SARS-CoV-2 from anterior nasal swab specimens.

Sponsors & Collaborators

  • iHealth Labs inc

    lead INDUSTRY

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-12
Primary Completion
2025-12-12
Completion
2025-12-12
FDA Device
Yes

Countries

  • United States
  • Puerto Rico

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 NCT07190131 on ClinicalTrials.gov