Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag Test

Completed

Conditions studied: Covid19

In brief

Performance of the LumiraDx SARS-CoV-2 Ag assay will be assessed by comparison to a reference method.

Key facts

Study ID

NCT04557046

Run by

LumiraDx UK Limited

People needed

1134

Starts

2020-06-26

Expected to finish

2020-09-24

Last updated by the study team

2026-06-12

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• 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).

You may not qualify if…

• 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

Where it is running

• Children's Pediatric Associates of Altamonte Springs — Altamonte Springs, Florida, United States
• Chappel Group — Kissimmee, Florida, United States
• Good Samaritan Minute Clinic, Georgia Tech — Atlanta, Georgia, United States
• Gvozden Pediatrics — Millersville, Maryland, United States
• Ardmore Family Practice — Winston-Salem, North Carolina, United States
• Physicians Quality Care of Jackson — Jackson, Tennessee, United States
• Village Health Partners — Plano, Texas, United States

Full record on ClinicalTrials.gov

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