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New At-Home test could detect flu and COVID in minutes

NCT ID NCT07430410

Diagnosis Sponsor: CorDx, Inc. Source: ClinicalTrials.gov ↗

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will test a new at-home rapid test that checks for flu A, flu B, and COVID-19 using a nasal swab. About 200 people with symptoms will use the test themselves, and their results will be compared to standard lab PCR tests. The goal is to see if the test is accurate and easy for people to use without training.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CorDx Tyfast Flu A/B & COVID-19 At-Home Multiplex Rapid Test (a device for detecting viral antigens from a nasal swab)
What this could lead to
If successful, this could provide a reliable at-home test for flu and COVID-19, making it easier for people to quickly know what they have and seek appropriate care.
What could go wrong
This is an early-stage validation study with only 200 participants. The test may not be as accurate as lab tests, and results could vary with different users or virus strains.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

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.

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: 1. Written informed consent obtained prior to study enrollment. 2. Male or female aged 2 years or older. 3. Subjects were tested with a Food Drug and Administration (FDA) cleared molecular assay no more than 2 days prior to the study visit. 4. Subject, aged 2 years or older, is currently exhibiting one 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 5 days of symptom onset. Subject must still be exhibiting symptoms on the day of sample collection. Exclusion Criteria: 1. 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. 2. Subject has had seasonal influenza vaccine within the past 5 days. 3. 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. 4. Subject is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir (Rapivab®). 5. 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. 6. 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. 7. 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.

COVID-19 influenza swine influenza

As listed by the trial registrant

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

Influenza A Influenza B SARS-CoV-2 infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.