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New rapid test could spot flu and RSV in minutes at your local clinic

NCT ID NCT04288921

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new rapid test (LumiraDx Influenza A/B + RSV Test) that uses a nasal swab to quickly detect flu A, flu B, and RSV. Over 500 people with cold or flu-like symptoms took part. The test was performed by healthcare workers at point-of-care sites and compared to standard lab methods to see how accurate it is.

What this could mean

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

What this could lead to
If successful, this test could provide fast, accurate flu and RSV diagnosis at clinics or pharmacies, helping doctors treat patients sooner.
What could go wrong
This is a completed diagnostic accuracy study, not a treatment trial. The test may not be as accurate in real-world settings as in controlled conditions.

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

525 people

The number who actually took part.

Started

Feb 2020

Finished

Mar 2020

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

Patients presenting with symptoms suggestive of Influenza or RSV infection

Ages

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

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: * The subject may be of any age and either sex. * Preliminary assessment of the subject by the Investigator/designee should be suggestive of influenza and/or RSV at the time of the study visit. The subject must exhibit two (2) or more of the following signs and symptoms for eligibility: stuffy or runny nose, sneezing, cough, sore throat, dyspnea (labored, difficult breathing), wheezing, fatigue, weakness and/or malaise, arthralgia (joint pain), myalgia (deep muscle aches), anorexia, vomiting, diarrhea, or headache. The onset of these symptoms must not have begun more than four (4) days prior to study enrollment. * The subject must have a fever of 100.0 °F or greater with the onset of the fever being within the past three (3) days and/or present at the time of the visit. Fever can be reported or taken at time of visit. Subjects 18 years and older must report having a fever, but a quantitative reported measurement is not necessary for inclusion. Exclusion Criteria: * The subject underwent a nasal wash/aspirate as part of standard of care testing during this study visit. * The subject is undergoing treatment currently and/or within the past 14 days of the study visit with an inhaled influenza vaccine (FluMist®) or anti-viral medication, which may include but is not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), or Baloxavir Marboxil (Xofluza™). * The subject is undergoing treatment currently or had undergone within the past 14 days of the study visit with RSV-related medication which may include but is not limited to Ribavirin (Virazole), RSV-IGIV (RespiGam) or palivizumab (Synagis). * 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. * The subject has previously participated in this research study

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Conditions

The condition(s) this trial relates to.

influenza respiratory syncytial virus infectious disease swine influenza

As listed by the trial registrant

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

Influenza, human Respiratory syncytial virus infections

Contacts and locations

Locations

  • Accel-West Volusia Pediatrics

    DeLand, Florida, 32720, United States

  • Access Medical Center

    Encinitas, California, 92024, United States

  • Advanced Pediatrics

    Vienna, Virginia, 22180, United States

  • Ardmore Family Practice

    Winston-Salem, North Carolina, 27103, United States

  • Complete Family Care Research

    Northglenn, Colorado, 80234, United States

  • Family Medical Associates

    Carrollton, Texas, 75010, United States

  • Gvozden Pediatrics

    Millersville, Maryland, 21108, United States

  • ImmunoE Health and Research

    Centennial, Colorado, 80112, United States

  • ImmunoE Health and Research Center

    Thornton, Colorado, 80233, United States

  • Jersey Shore UMC

    Neptune City, New Jersey, 07753, United States

  • Kent Plaza Pediatrics

    Jackson, New Jersey, 08527, United States

  • Lisa Connery MD

    Norman, Oklahoma, 73069, United States

  • Madera Family Medical Group

    Madera, California, 93637, United States

  • MedHelp Urgent Care

    Birmingham, Alabama, 35235, United States

  • New Medical

    Wichita, Kansas, 67205, United States

  • Nona Pediatric Center

    Orlando, Florida, 32829, United States

  • North Texas Family Practice

    Plano, Texas, 75093, United States

  • Pediatric Associates of Charlottesville

    Charlottesville, Virginia, 22902, United States

  • Pediatric Care

    Bountiful, Utah, 84010, United States

  • Southwest Care

    Santa Fe, New Mexico, 87505, United States

More trials for these conditions

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