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

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.

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Key information

Conditions

COVID - 19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Influenza A Influenza B Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

iHealth Site 001, Quebradillas, Puerto Rico

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 2 years or older
Subject is currently exhibiting two or more symptoms associated with COVID-19 or influenza (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 6 days of symptom onset- For Antigen assay only). 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 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®), and 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 And Covid-19 Diagnostic Test

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.

Primary outcomes

Sensitivity and Specificity of the Investigational Test for Detection of Influenza A, Influenza B and SARS-CoV-2 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

Evaluation of iHealth COVID-19/Flu A&B Rapid Test for SARS-CoV-2 and Flu A&B Detection in Symptomatic Individuals

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Sep 24, 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.

Published trials that share one or more normalized conditions with this study.

Completed