Performance Evaluation of LumiraDx SARS-CoV-2, Flu A/B, and RSV Tests for COVID-19 Assessment (NCT05268939) | Clinical Trial Compass
CompletedNot Applicable
Performance Evaluation of LumiraDx SARS-CoV-2, Flu A/B, and RSV Tests for COVID-19 Assessment
United States589 participantsStarted 2022-01-04
Plain-language summary
A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 \& FLU A/B Test, and LumiraDx SARS-CoV-2 \& RSV Test at Point of Care Testing Sites. Subjects presenting with symptoms suggestive of COVID-19 and/or Influenza and/or RSV will be consented and asked to donate swab sample(s) for testing in the device(s) under evaluation.
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
. Preliminary assessment of the subject by the Investigator/designee should be suggestive of COVID-19 and /or influenza and/or RSV at the time of the study visit.
. The subject must present in one of the following two cohorts:
. Written informed consent must be obtained prior to study enrollment. A subject who is a legal adult 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 consent must give written informed consent and agree to comply with study procedures. Active assent should be obtained from children of appropriate intellectual age (as defined by the IRB)
Exclusion criteria
. The subject underwent a nasal wash/aspirate as part of standard of care testing during this study visit.
. Subjects undergoing treatment currently and/or within the past fourteen (14 days of the study visit with an inhaled influenza vaccine (FluMist®) or with antiviral medication, which may include but is not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), or Baloxavir Marboxil (Xofluza™)
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 point-of-care diagnostic device that checks for COVID-19, flu A, flu B, and RSV all at once — if I have overlapping symptoms, could a test like the LumiraDx system help my doctor figure out faster which virus I actually have?
2Since this study is completed and was focused on how well healthcare professionals could use this device accurately at the point of care, has the evidence from trials like this one changed how you approach rapid testing in your clinic for respiratory illness?
3This wasn't a treatment trial — it was evaluating a diagnostic tool — so how does getting a faster or more accurate diagnosis for COVID-19 versus flu versus RSV actually change the treatment options you'd consider for me?
4Because this trial measured usability by healthcare professionals rather than testing a new drug or therapy, are there any risks to me personally from being tested with a newer rapid diagnostic device compared to a standard lab test?
5Now that this trial is completed, is the LumiraDx multi-virus test something that's available at your practice or nearby clinics, and would it be worth discussing whether that kind of testing makes sense for my situation?
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 by health care professionals
. Subjects undergoing treatment currently and/or within the past thirty (30) days of the study with prescription medication to treat novel Coronavirus SARS-CoV-2 infection, which may include but is not limited to Remdesivir (Veklury) or receiving convalescent plasma therapy for SARS-CoV-2;
. The subject is undergoing treatment currently or had undergone within the past fourteen (14) days of the study visit with RSV-related medication which may include but is not limited to Ribavirin (Virazole), RSV-IGIV (RespiGam) or palivizumab (Synagis).
. 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.
. The subject has previously participated in this research study (CS-1262-01).