Research & Evaluation of LumiraDx SARS-CoV-2 (COVID-19) Point of Care Ab Test (NCT04597047) | Clinical Trial Compass
CompletedNot Applicable
Research & Evaluation of LumiraDx SARS-CoV-2 (COVID-19) Point of Care Ab Test
United States42 participantsStarted 2020-07-09
Plain-language summary
Evaluation of the agreement between fingerstick samples, venous blood, serum and plasma samples when using the LumiraDx SARS-CoV-2 Ab Test against the reference method, using standard qualitative comparison techniques.
Who can participate
Age range
2 Years
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
. Male and female subjects aged ≥ 2 years.
. The subject must have a documented SARS-CoV-2 PCR test in the past 7-30 days. (subjects must be 14+ days post symptom onset at the time of recruitment).
. Written informed consent must be obtained prior to study enrollment.
. A subject who is 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 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).
Exclusion criteria
. Skin lesions or conditions that would preclude a fingerstick and or a venous blood draw.
. 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.
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 antibody test for COVID-19 rather than a treatment — can you help me understand whether my situation calls for antibody testing, and whether a test like this would give us useful information about my case?
2Since this study has already been completed, would you be able to look up its results and tell me how accurately this LumiraDx antibody test performed compared to standard lab testing?
3Antibody tests detect a past infection or immune response rather than an active one — given my current symptoms or diagnosis, would an antibody test or an antigen/PCR test be more appropriate for what we're trying to find out?
4If this point-of-care test is now available or being used in practice based on this study's findings, is it something that could be ordered for me at my clinic visit rather than sending samples to an outside lab?
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.