CompletedNot Applicable

Clinical Validation of the LumiraDx SARS-CoV-2 & Flu A/B Combo Test

United States1,081 participantsStarted 2023-05-04

Plain-language summary

This is a prospective multicenter study conducted to evaluate the performance of the LumiraDx SARS-CoV-2 \& Flu A/B tests at point of care sites. Subjects presenting with symptoms suggestive of coronavirus disease 2019 (COVID-19) and Influenza at the time of the study visit will be enrolled and asked to donate swab sample(s) for testing on the device under evaluation.

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

. Written informed consent obtained prior to study enrollment.
. Male or female aged 2 years of age or older
. Subject is currently exhibiting two or more symptoms associated with COVID-19 or influenza (such as, but not limited to, fever, chills, cough, shortness of breath or difficulty breathing, fatigue, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting or diarrhea) and must present within 6 days of symptom onset. Subject must still be exhibiting symptoms on the day of sample collection.

Exclusion criteria

. Subject does not understand or is not able and willing to sign the study informed consent or be verbally assented.
. Subject has had the seasonal influenza and/or the SARS-CoV-2 vaccine within the past 5 days.

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 & Flu A/B in point of care settings

Timeframe: 6 months

Trial details

NCT IDNCT05787444

SponsorLumiraDx UK Limited

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-04-02

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