CompletedNot Applicable

POC Performance Evaluation of LumiraDx SARS-CoV-2 Ag Ultra and SARS-CoV-2 & Flu A/B Tests.

United States716 participantsStarted 2023-02-09

Plain-language summary

This is a prospective multicenter study conducted to evaluate the performance of the LumiraDx SARS-CoV-2 Ag Ultra test in detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and LumiraDx SARS-CoV-2 \& Flu A/B test in differential detection of SARS-CoV-2, Influenza A (Flu A) and Influenza B (Flu B) at point of care sites. Subjects presenting with symptoms suggestive of coronavirus disease 2019 (COVID-19) and/or Influenza at the time of the study visit will be enrolled 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

. Subject may be of any age or sex.
. Self-reported symptoms by the subject and/or preliminary assessment of the subject by the Investigator/designee should be suggestive of COVID-19 and/or Influenza at the time of the study visit. The subject must present as symptomatic, exhibiting one or more of the following signs and symptoms: 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.

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Performance evaluation of the LumiraDx SARS-CoV-2 Ag Ultra by health care professionals

Timeframe: 6 months

Performance evaluation by health care professionals

Timeframe: 6 months

Trial details

NCT IDNCT05728970

SponsorLumiraDx UK Limited

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-04-11

View on ClinicalTrials.gov More SARS-CoV-2 trials