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OpenTrials
Completed

NCT Number: NCT07308158

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

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.

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Key information

Age range

6 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

iHealth Site 001, Quebradillas, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Investigational Flu A/B Covid-19 and RSV Diagnostic Test

Diagnostic Test

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

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

iHealth Labs inc

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 29, 2025
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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