Covid Flu A/B and RSV 4 in 1 Diagnostic Test

January 7, 2026 updated by: iHealth Labs inc

Human Factors and Clinical Validation of the iHealth Labs Inc iHealth Flu A&B/COVID-19/RSV Rapid Test in Anterior Nares Nasal Samples For Over the Counter (OTC) Use

The goal of this observational study is to evaluate the diagnostic performance of an investigational Flu A/B, COVID-19 and RSV test in patients 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, , SARS-CoV-2 and respiratory syncytial virus 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1119

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Quebradillas, Puerto Rico, 00678
        • iHealth Site 001
      • San Juan, Puerto Rico, 000927
        • iHealth Site 022
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35242
        • iHealth Site 006
      • Trussville, Alabama, United States, 35173
        • iHealth Site 021
    • California
      • Dublin, California, United States, 94568
        • iHealth Site 017
      • Huntington Park, California, United States, 90255
        • iHealth Site 007
      • Toluca Lake, California, United States, 91602
        • iHealth Site 026
    • Florida
      • DeLand, Florida, United States, 32720
        • iHealth Site 011
      • Doral, Florida, United States, 33122
        • iHealth Site 013
      • Fort Lauderdale, Florida, United States, 33308
        • iHealth Site 004
      • Fort Lauderdale, Florida, United States, 33312
        • iHealth Site 005
      • Palm Springs, Florida, United States, 33461
        • iHealth Site 019
      • Tamarac, Florida, United States, 33321
        • iHealth Site 014
    • Idaho
      • Ammon, Idaho, United States, 83406
        • iHealth Site 009
    • New Jersey
      • Edison, New Jersey, United States, 08820
        • iHealth Site 027
    • South Carolina
      • Simpsonville, South Carolina, United States, 29681
        • iHealth Site 015
      • Spartanburg, South Carolina, United States, 29301
        • iHealth Site 016
    • Tennessee
      • Chattanooga, Tennessee, United States, 37412
        • iHealth Site 020
    • Texas
      • Brownsville, Texas, United States, 78520
        • iHealth Site 003
      • Edinburg, Texas, United States, 78539
        • iHealth Site 002
      • El Paso, Texas, United States, 79902
        • iHealth Site 018
      • Mesquite, Texas, United States, 75149
        • iHealth Site 023
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • iHealth Site 025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals with flu-like symptoms presenting to participating clinical sites

Description

Inclusion Criteria:

  • Written informed consent obtained prior to study enrollment.
  • Male or female aged six (6) months or older.
  • Subject is currently exhibiting two or more symptoms associated with COVID-19, influenza or RSV (such as, but not limited to, fever, chills, cough, shortness of breath or difficulty breathing, fatigue, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting or diarrhea and must present within six (6) days of symptom onset). Subject must still be exhibiting symptoms on the day of sample collection.

Exclusion Criteria:

  • Subject who is 18 years of age (or the state's legal age of majority) or older and does not understand or is not able and willing to sign the study informed consent.
  • Subject has had seasonal influenza and/or the SARS-CoV-2 and/or the RSV vaccine within the past 5 days.
  • Subject is not able to tolerate sample collection, or is not willing to contribute the required swab samples for testing or complete the study procedures.
  • Subject is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), or peramivir (Rapivab®).
  • Subjects currently undergoing treatment and/or within the past thirty (30) days with prescription medication to treat novel Coronavirus SARS-CoV-2 infection, which may include but is not limited to Remdesivir (Veklury), Paxlovid, molnupiravir or receiving convalescent plasma therapy for SARS-CoV-2.
  • Subjects who have taken Evusheld (tixagevimab/cilgavimab) within the last 90 days.
  • Subjects who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit prior to the study sample collection.
  • Subjects who have had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and Specificity of the Investigational Test for Detection of Influenza A, Influenza B, SARS-CoV-2 and Respiratory Syncytial Virus Compared to an FDA-Cleared Reference Method
Time Frame: Within approximately 5 days of specimen collection (time needed for both investigational and comparator test results)
Within approximately 5 days of specimen collection (time needed for both investigational and comparator test results)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iHealth Labs inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2024

Primary Completion (Actual)

December 12, 2025

Study Completion (Actual)

December 12, 2025

Study Registration Dates

First Submitted

December 15, 2025

First Submitted That Met QC Criteria

December 15, 2025

First Posted (Estimated)

December 29, 2025

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iH018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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