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New rapid test for COVID and flu put to the test

NCT ID NCT07190131

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study checked how well a new rapid test (iHealth COVID-19/Flu A&B) can detect COVID-19 and flu A and B in people with respiratory symptoms. About 588 people with two or more symptoms provided nose swabs. The test's results were compared to a standard lab test to see how accurate it is.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

588 people

The number who actually took part.

Started

Nov 2024

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Individuals with flu-like symptoms presenting to participating clinical sites

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • iHealth Site 001

    Quebradillas, 00678, Puerto Rico

  • iHealth Site 002

    Edinburg, Texas, 78539, United States

  • iHealth Site 003

    Brownsville, Texas, 78520, United States

  • iHealth Site 004

    Fort Lauderdale, Florida, 33308, United States

  • iHealth Site 005

    Fort Lauderdale, Florida, 33312, United States

  • iHealth Site 006

    Birmingham, Alabama, 35242, United States

  • iHealth Site 007

    Huntington Park, California, 90255, United States

  • iHealth Site 008

    Los Angeles, California, 90057, United States

  • iHealth Site 009

    Ammon, Idaho, 83406, United States

  • iHealth Site 013

    Doral, Florida, 33122, United States

  • iHealth Site 014

    Tamarac, Florida, 33321, United States

  • iHealth Site 017

    Dublin, California, 94568, United States

  • iHealth Site 020

    Chattanooga, Tennessee, 37412, United States

  • iHealth Site 021

    Trussville, Alabama, 35173, United States

  • iHealth Site 024

    Smithfield, Pennsylvania, 15478, United States

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