Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag Test (NCT04557046) | Clinical Trial Compass
CompletedNot Applicable
Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag Test
United States1,134 participantsStarted 2020-06-26
Plain-language summary
Performance of the LumiraDx SARS-CoV-2 Ag assay will be assessed by comparison to a reference method.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was testing the accuracy of the LumiraDx COVID-19 antigen test — can you explain what it means that it was a 'performance evaluation' study, and whether that kind of research would have had any direct treatment benefit for participants?
2Since this trial is already completed, would the results affect which COVID-19 diagnostic test my doctor's office or clinic currently uses, and is there anything I should know about how reliable antigen tests like this one are compared to PCR testing?
3This study was listed as Phase NA, which often means it wasn't testing a drug or therapy — so if I'm looking for treatment options for COVID-19, is this the kind of trial worth discussing, or should we focus on finding something that tests an actual treatment?
4If the LumiraDx antigen test was evaluated in this trial, is that the type of test I might be given if I come in with symptoms, and how confident should I be in a positive or negative result from it?
5Are there completed or ongoing trials you'd recommend I look into that go beyond diagnostic accuracy and actually evaluate treatments or therapies for my specific situation with COVID-19?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Performance Evaluation
Timeframe: On day of the medical encounter (1 day)