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New rapid test could spot COVID and flu in minutes

NCT ID NCT05787444

Diagnosis Sponsor: LumiraDx UK Limited 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study checked how well a new rapid test (LumiraDx) detects COVID-19 and flu A/B from a simple nose swab. Over 1,000 people with symptoms took part at clinics. The test aims to give fast results at the point of care, helping doctors tell these illnesses apart quickly.

What this could mean

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

Active substance
LumiraDx SARS-CoV-2 & Flu A/B test (rapid diagnostic test)
What this could lead to
If successful, this test could provide quick, accurate results for COVID-19 and flu at clinics or pharmacies, helping doctors decide treatment faster.
What could go wrong
This is a completed validation study, not a treatment trial. The test may not be as accurate in real-world use or for asymptomatic people, and it only works within 6 days of symptoms.

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

1,081 people

The number who actually took part.

Started

May 2023

Finished

Apr 2024

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

The entire population that met the eligibility criteria. Symptomatic subjects who are currently exhibiting two or more symptoms associated with COVID-19 or influenza and present within 6 days of symptom onset. Subject must still be exhibiting symptoms on the day of sample collection.

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 of age or older 3. 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. Subject must still be exhibiting symptoms on the day of sample collection. Exclusion Criteria: 1. Subject does not understand or is not able and willing to sign the study informed consent or be verbally assented. 2. Subject has had the seasonal influenza and/or the SARS-CoV-2 vaccine within the past 5 days. 3. Subject is not able to tolerate sample collection. 4. Subject is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir (Rapivab®). 5. Subjects undergoing treatment currently 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 taken Evusheld (tixagevimab/cilgavimab) within the last 90 days. 7. Subjects who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit prior to study sample collection. 8. 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.

Asymptomatic COVID-19 Influenza A Influenza B SARS-CoV-2

Contacts and locations

Locations

  • Cullman Clinical Trials

    Cullman, Alabama, 35055, United States

More trials for these conditions

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