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New rapid test for infection and inflammation put to the test

NCT ID NCT05180110

Diagnosis Sponsor: LumiraDx UK Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how well a new, quick finger-prick test (LumiraDx CRP) measures CRP levels compared to a standard lab test. CRP is a marker of infection, inflammation, or tissue injury. 79 adults with symptoms of these conditions took part. The goal was to see if the new test is accurate enough for doctors to use at the point of care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

79 people

The number who actually took part.

Started

Nov 2021

Finished

May 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients (≥18 years) presenting to participating UK clinical sites with symptoms suggestive of infection, tissue injury, or inflammatory disorders. Eligible patients were recruited from emergency departments, acute medical units, inpatient wards, and outpatient clinics, including NPT settings.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Infections infectious disease Inflammation inflammatory disease injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infections Inflammation Tissue injury

Contacts and locations

Locations

  • Royal Infirmary Edinburgh

    Edinburgh, United Kingdom

  • St Georges Hospital

    London, United Kingdom

  • University College London Hospital

    London, United Kingdom

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