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Rapid COVID-19 test put to the test in Real-World clinics

NCT ID NCT04557046

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 quick COVID-19 antigen test called LumiraDx at various point-of-care sites, like clinics. Over 1,100 people with COVID-19 symptoms took part. The test's accuracy was compared to standard lab methods to see how well it detects the virus.

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 provide a fast, reliable test for COVID-19 that can be used at clinics or testing sites, helping with quicker diagnosis.
What could go wrong
This is a completed study evaluating test accuracy, not a treatment. The test may not be as accurate as lab-based methods, and results depend on proper sample collection.

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

1,134 people

The number who actually took part.

Started

Jun 2020

Finished

Sep 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

Approximately six (6) geographically diverse POC (Point of Care) locations (e.g. physician office laboratories, urgent cares, emergency departments, outpatient clinics including drive through testing sites or research centers) in the U.S. will participate in the study. Males and females of any age may be enrolled, and should be represented in proportions representative of the population.

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: * 1\. The subject may be of any age and either sex. * 2\. Preliminary assessment of the subject by the Investigator/designee should be suggestive of COVID-19 at the time of the study visit. The subject must present as symptomatic, meaning they have exhibited one or more of the following signs and symptoms for eligibility: fever, cough, shortness of breath, difficulty breathing, muscle pain, headache, sore throat, chills, repeated shaking with chills, new loss of taste or smell. The onset of these symptoms will be recorded. or The subject must have a documented SARS-CoV-2 PCR test in the past 48 hours. * 3\. Written informed consent must be obtained prior to study enrollment. 1. A subject who is eighteen (18) years or older must be willing to give written informed consent and must agree to comply with study procedures. 2. The Legal Guardian or Legal Authorized Representative of a subject who is under the age of eighteen (18) 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 defined by the IRB). 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\. The subject has previously participated in this research study

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Conditions

The condition(s) this trial relates to.

COVID-19

As listed by the trial registrant

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

COVID19

Contacts and locations

Locations

  • Ardmore Family Practice

    Winston-Salem, North Carolina, 27103, United States

  • Chappel Group

    Kissimmee, Florida, 34744, United States

  • Children's Pediatric Associates of Altamonte Springs

    Altamonte Springs, Florida, 32701, United States

  • Good Samaritan Minute Clinic, Georgia Tech

    Atlanta, Georgia, 30318, United States

  • Gvozden Pediatrics

    Millersville, Maryland, 21108, United States

  • Physicians Quality Care of Jackson

    Jackson, Tennessee, 38305, United States

  • Village Health Partners

    Plano, Texas, 75024, United States

More trials for these conditions

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