Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag ULTRA Test (NCT05506618) | Clinical Trial Compass
CompletedNot Applicable
Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag ULTRA Test
United States758 participantsStarted 2022-06-30
Plain-language summary
Performance of the LumiraDx SARS-CoV-2 Ag ULTRA assay will be assessed by comparison to a reference method
Who can participate
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject may be of any age or gender.
. 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.
. Participant (or parent/legal guardian) capable and willing to give informed consent/assent.
Exclusion criteria
. The subject underwent a nasal wash/aspirate as part of standard of care testing during this study visit.
. 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.
. 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.
. The subject has previously participated in this research study.
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 a rapid COVID-19 antigen test called the LumiraDx ULTRA — since it's now completed, has the performance data been published, and does it change which at-home or rapid tests you'd recommend I use?
2Since this was a diagnostic accuracy study rather than a treatment trial, what does 'performance evaluation' actually mean in practice — specifically, how sensitive and specific was this test compared to the gold-standard PCR test?
3Given that this study is completed but I may still need reliable COVID-19 testing, are there newer or better-validated rapid antigen tests you'd suggest I use based on the most current evidence?
4If the LumiraDx ULTRA test performed well in this study, is it something that's now available and would you recommend it over other rapid tests for someone in my situation?
5Since this was a non-interventional diagnostic trial with no phase designation, does participating in or using findings from a study like this carry any different risks or considerations compared to a standard treatment trial?
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.