CompletedNot Applicable

COVID-19: A POC Test Under Research & Evaluation

United Kingdom523 participantsStarted 2020-05-01

Plain-language summary

Collection of nasal/nasopharyngeal/throat swabs and blood samples from patients presenting at their designated care facility displaying symptoms of COVID-19 and undergoing a SOC SARS-CoV-2 test or those who have tested positive in the past to aid development, calibration and performance evaluation for the LumiraDx POC test.

Who can participate

Age range

18 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

. Patient is at least 18 years of age.
. Patient meets either of the below categories:
. Patient is presenting with symptoms indicative of COVID-19 and will be completing SOC sampling for SARS-CoV-2 PCR testing. (Eligible for Arm A)
. Patient has had a confirmed positive SARS-CoV-2 PCR test result in the past. (Eligible for Arm B)

Exclusion criteria

. The patient does not have the capacity to consent as determined by the Research Team (and the impartial witness if applicable).
. The patient is deemed to be unsuitable for research at the research teams' discretion.

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.

1Since this trial has already been completed, would the results from the LumiraDx point-of-care test study be relevant to how I'm being tested or diagnosed for COVID-19 today?
2This trial was measuring how accurately the LumiraDx test detected both the virus itself (antigen) and the body's immune response (IgG/IgM antibodies) — do you think antibody testing versus antigen testing matters for my specific situation?
3Because this was a diagnostic accuracy study rather than a treatment trial, does it change anything about my care options, or is it more about how reliably a test like this can identify COVID-19 cases?
4Given that this study compared the LumiraDx assay against reference methods, would you say the point-of-care tests I might encounter now are generally considered accurate enough to guide treatment decisions in my case?
5Are there other completed or ongoing studies looking at COVID-19 diagnostics or treatments that might be more directly relevant to my current health 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

Performance of the LumiraDx Assay versus reference methods with regards to clinical sensitivity and specificity for the detection of the SARS-COV-2 IgG/IgM and viral antigen in patient samples.

Timeframe: 1 Year approx

Trial details

NCT IDNCT04408066

SponsorLumiraDx UK Limited

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-05-26

View on ClinicalTrials.gov More COVID-19 trials