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Rapid COVID and flu tests put to the test in real clinics

NCT ID NCT05728970

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study checked how accurate two rapid tests (LumiraDx SARS-CoV-2 Ag Ultra and LumiraDx SARS-CoV-2 & Flu A/B) are at detecting COVID-19 and flu in people with symptoms. 716 participants provided nasal swabs at clinics. The results were compared to standard lab tests to measure sensitivity and specificity.

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

716 people

The number who actually took part.

Started

Feb 2023

Finished

Apr 2023

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 inclusion criteria and none of the exclusion criteria. Symptomatic subjects will have symptoms suggestive of COVID-19 and/or Influenza.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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. Subject may be of any age or sex. 2. Self-reported symptoms by the subject and/or preliminary assessment of the subject by the Investigator/designee should be suggestive of COVID-19 and/or Influenza at the time of the study visit. The subject must present as symptomatic, exhibiting one or more of the following signs and symptoms: fever, cough, shortness of breath, difficulty breathing, muscle pain, headache, sore throat, chills, repeated shaking with chills, new loss of taste or smell congestion or runny nose, diarrhea, nausea or vomiting. The onset of these symptoms will be recorded and will be within the last twelve (12) days. 3. Participant (or parent/legal guardian) capable and willing to give informed consent/assent. Exclusion Criteria: 1. The subject underwent a nasal wash/aspirate as part of standard of care testing during this study visit. 2. The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, drug, or device including either treatment or therapy. 3. Subjects undergoing treatment currently and/or within the past thirty (30) days of the study with medication to treat novel Coronavirus SARS-CoV-2 viral infections, which may include but is not limited to; COVID-19 antivirals (Lagevrio, PAXLOVID), Remdesivir (Veklury) or receiving convalescent plasma therapy for SARS-CoV-2. 4. Subjects undergoing treatment currently and/or within the past fourteen (14) days of the study visit with an inhaled influenza vaccine (FluMist®) or with anti-viral medication, which may include but is not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), Baloxavir Marboxil (Xofluza™), Palivizumab (Synagis®), or ribavirin. 5. The subject previously participated in this study.

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Conditions

The condition(s) this trial relates to.

Coronavinae infectious disease COVID-19 Infections influenza lung disorder swine influenza

As listed by the trial registrant

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

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

Contacts and locations

Locations

  • Alliance for Multispecialty Research, LLC

    Layton, Utah, 84041, United States

  • Barrett Clinic

    La Vista, Nebraska, 68128, United States

  • Hillcrest Medical Research

    DeLand, Florida, 32720, United States

  • Hillcrest Medical Research, LLC

    DeLand, Florida, 32720, United States

  • Marisela Gonzalez MD PA

    Miami, Florida, 33155, United States

  • Mercy Family Clinic

    Dallas, Texas, 75211, United States

  • Meridian Clinical Research

    Lincoln, Nebraska, 68510, United States

  • Meridian Clinical Research, LLC. / Velocity Clinical Research

    Hampton, Virginia, 23666, United States

  • Paragon Rx Clinical, Inc

    Garden Grove, California, 92840, United States

  • Torrance Clinical Research Institute Inc.

    Lomita, California, 90717, United States

More trials for these conditions

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