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

NCT ID NCT05506618

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 evaluates how well the LumiraDx SARS-CoV-2 Ag ULTRA test detects COVID-19 when used at point-of-care locations like clinics or pharmacies. Participants with COVID-19 symptoms provide nasal and nasopharyngeal swabs, and the test results are compared to a standard lab reference method. The goal is to see if this rapid test can reliably identify infections quickly and accurately.

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 accurate, this test could provide fast, reliable COVID-19 diagnosis at clinics or pharmacies, helping to quickly identify infections.
What could go wrong
The test may not be as accurate as lab tests, and results depend on sample quality and timing of symptoms.

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

758 people

The number who actually took part.

Started

Jun 2022

Finished

Oct 2022

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

Symptomatic patients presented to the participating healthcare facilities, urgent care centers, or research sites

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 gender. 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 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. or The subject is asymptomatic and is neither currently exhibiting signs or symptoms of SARS-CoV-2 nor has experienced signs or symptoms within the past fourteen (14) days, and has not knowingly been exposed to someone with a positive test result within the last fourteen (14) 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 like illness symptoms, which may include but is not limited to Remdesivir or convalescent plasma therapy for SARS-CoV-2. 4. 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.

COVID -19

Contacts and locations

Locations

  • Advanced Investigative Medicine

    Hawthorne, California, 90250, United States

  • Cahaba Research, Inc.

    Birmingham, Alabama, 35242, United States

  • Cyn3rgy Research

    Gresham, Oregon, 97030, United States

  • Healthy Life Research, Inc.

    Miami, Florida, 33175, United States

  • The Machuca Foundation, Inc.

    Las Vegas, Nevada, 89104, United States

  • Zion Urgent Care

    Katy, Texas, 77494, United States

More trials for these conditions

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