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

Completed

Conditions studied: COVID - 19, Influenza A, Influenza B

In brief

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.

Key facts

Study ID: NCT07190131
Run by: iHealth Labs inc
People needed: 588
Starts: 2024-11-12
Expected to finish: 2025-12-12
Last updated by the study team: 2026-01-08

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

iHealth Site 006 — Birmingham, Alabama, United States
iHealth Site 021 — Trussville, Alabama, United States
iHealth Site 017 — Dublin, California, United States
iHealth Site 007 — Huntington Park, California, United States
iHealth Site 008 — Los Angeles, California, United States
iHealth Site 013 — Doral, Florida, United States
iHealth Site 004 — Fort Lauderdale, Florida, United States
iHealth Site 005 — Fort Lauderdale, Florida, United States
iHealth Site 014 — Tamarac, Florida, United States
iHealth Site 009 — Ammon, Idaho, United States
iHealth Site 024 — Smithfield, Pennsylvania, United States
iHealth Site 020 — Chattanooga, Tennessee, United States
iHealth Site 003 — Brownsville, Texas, United States
iHealth Site 002 — Edinburg, Texas, United States
iHealth Site 001 — Quebradillas, Puerto Rico

Full record on ClinicalTrials.gov

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