New device aims to detect flu, RSV, and COVID-19 in one quick test
NCT ID NCT04782336
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
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79 people
The number who actually took part.
- Started
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Jun 2021
- Finished
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Aug 2021
- Lead sponsor
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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
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Barts Health NHS Trust
London, E1 1BB, United Kingdom
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Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
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Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
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NHS Lothian - Royal Hospital for Children & Young People
Edinburgh, United Kingdom
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St George's University Hospitals NHS Foundation
London, SW17 0QT, United Kingdom
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University College London Hospitals NHS Foundation Trust
London, NW1 2PG, United Kingdom
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Other studies related to the condition(s) this trial covers.
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