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New device aims to detect flu, RSV, and COVID-19 in one quick test

NCT ID NCT04782336

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study collected nasal swabs, throat swabs, and saliva samples from 79 people with symptoms of flu, RSV, or COVID-19. The samples were used to help evaluate a point-of-care device called LumiraDx, which aims to quickly and accurately detect these viruses. The study focused on testing the device's performance, not on treating any disease.

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 could lead to a fast, accurate point-of-care test for multiple respiratory viruses at once.
What could go wrong
This is a small sample collection study, not a treatment trial. The device's accuracy still needs full validation in larger studies.

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

79 people

The number who actually took part.

Started

Jun 2021

Finished

Aug 2021

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

Influenza or RSV or SARS-CoV-2 suspected adult and paediatric patients. Participants should be suspected of either Influenza A/B, RSV or COVID-19 when presenting at their designated care or testing facility. Participants may be of any age, there will be no upper or lower age limit.

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: * Preliminary assessment of the patient by the Investigator/Designee should be suggestive of Influenza and/or COVID-19 and/or RSV at the time of the study visit. This may include referral to a testing facility. * The patient will be completing or has completed a Standard of Care (SOC) Influenza A/B, COVID-19 and/or an RSV test on the day of study. This SOC sampling can be conducted prior or post the patient consenting to this study. * Written Informed Consent must be obtained prior to study enrolment: * A participant who is 16 years or older must be willing to give written informed consent and must agree to comply with study procedures. * The Legal Guardian or Legal Authorised Representative of a participant who is under the age of 16 must give written informed consent and agree to comply with study procedures. Active written assent should be obtained from children of appropriate intellectual age (as determined by the consent taker in accordance with GCP). Exclusion Criteria: * The patient underwent a nasal wash/aspirate as part of standard of care testing during their current visit. * The patient 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 patient 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 patient 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 patient does not have the capacity to consent as determined by the Research Team. * The patient is deemed to be unsuitable for research at the Research Team's discretion.

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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

  • Barts Health NHS Trust

    London, E1 1BB, United Kingdom

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ, United Kingdom

  • Leicester Royal Infirmary

    Leicester, LE1 5WW, United Kingdom

  • NHS Lothian - Royal Hospital for Children & Young People

    Edinburgh, United Kingdom

  • St George's University Hospitals NHS Foundation

    London, SW17 0QT, United Kingdom

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2PG, United Kingdom

More trials for these conditions

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