CompletedNot Applicable

A Performance Evaluation of the LumiraDx Point of Care CRP Assay

United Kingdom79 participantsStarted 2021-11-25

Plain-language summary

In patients with symptoms of infection, tissue injury and inflammatory disorders the study will evaluate agreement between the CRP measurements from the LumiraDx POC CRP assay and the Siemens Dimension Xpand Plus CRP assay, as an aid in evaluation and detection of infection, tissue injury and inflammatory disorders.

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: * Patients 18 years and over at the time of consent * Willing and able to provide written informed consent and comply with study procedures * Presenting with symptoms of infection, tissue injury, inflammatory disorders. This includes but not limited to : respiratory tract infection (upper and lower), rheumatoid arthritis, Lupus, burns, trauma, inflammatory bowel disease. Exclusion Criteria: * The patient is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic or drug including either treatment or therapy. * Skin lesions or conditions that would preclude a fingerstick and/or a venous blood draw. * Patient has previously participated in this study * Any patient with critical illness or requiring a time critical intervention * Patient with end of life or palliative care * Patient suffering from the following conditions: Myeloma, monoclonal gammopathy, extreme lipaemia * Patient is deemed medically unfit to participate.

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

To determine the performance of the LumiraDx POC CRP assay when compared to the Siemens Dimension Xpand Plus CRP in patients with symptoms of infection, inflammation, or injury.

Timeframe: 2 months

Trial details

NCT IDNCT05180110

SponsorLumiraDx UK Limited

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-01-11

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