InflammationREACTNCT05180110
A Performance Evaluation of the LumiraDx Point of Care CRP Assay
An observational study of Inflammation and Infections, run by LumiraDx UK Limited at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation, Infections, Tissue Injury
- What is being tested?
- Venepuncture and Fingerstick
- How many people
- 79 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 25 Nov 2021to 30 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Royal Infirmary Edinburgh
Edinburgh
St Georges Hospital
London
University College London Hospital
London
About this study
Official title: A Performance Evaluation of the LumiraDx Point of Care CRP Assay.
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.
Read the detailed description
This is a performance evaluation study designed to assess the precision and accuracy of the LumiraDx point of Care (POC) C-reactive Protein (CRP) test when used in patients presenting with symptoms of infection, tissue injury or inflammatory disorder.
The LumiraDx POC CRP test is a quantitative immunoassay providing results in under 10 minutes. The accuracy of the LumiraDx POC CRP test will be assessed using capillary whole blood, venous blood, and plasma samples, by comparison to the CRP results obtained from the same individuals as analysed by trained laboratory professionals using the reference device, Siemens Dimension Xpand Plus CRP assay. The results of this study are intended to be used for regulatory filings for use as an in vitro diagnostic test in the UK, European Union (EU) and other relevant geographies.
Adults (aged 18 and over at time of consent) presenting to the study sites with symptoms of infection, tissue injury or inflammatory disorder will be included in the study. Approximately 250 patients will be recruited to ensure that sufficient suitable patients are enrolled and to allow for a small level of exclusions.
After obtaining informed consent, blood tube samples will be drawn and fingerstick samples of capillary blood will be taken from the subject, these will be applied directly onto unique test strips for immediate measurement of CRP on the LumiraDx POC instrument.
The CRP results obtained via the LumiraDx CRP test will be used in a set of comparative analyses designed to determine the performance characteristics of the test. This study is an observational, cross-sectional design. As an observational study of an investigative device, results obtained during the course of the study will not inform or alter patient management or treatment decisions in any way.
- Conditions
- Inflammation, Infections, Tissue Injury
- Being tested
- Venepuncture, Fingerstick
- Medical subject headings
- Inflammation, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenepunctureDiagnostic test
Venous blood draw
FingerstickDiagnostic test
Capillary blood draw
| Study group | Role | What they receive |
|---|---|---|
| Symptoms of inflammation, Infection, tissue injury | Venous blood draw of up to 24mL and up to 6 capillary fingersticks Receives: Diagnostic Test: Venepuncture; Diagnostic Test: Fingerstick |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measurement of blood samples from patients with symptoms of inflammation, infection or injury in a reference method and in the LumiraDx method to assess accuracy of the LumiraDx method
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start25 Nov 2021
- Primary completion11 Jan 2022
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- LumiraDx UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alasdair Gray, MD, Principal investigator, NHS LothianJames Harnett, Principal investigator, University College London Hospital NHS Foundation TrustPhil Moss, Principal investigator, St Georges University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180110
- Sponsor's protocol ID
- S-CLIN-PROT-00008
- Acronym
- REACT
- Status last verified
- Jun 2026
- First submitted
- 17 Dec 2021
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Performance Evaluation of the LumiraDx Point of Care CRP Assay.
- ClinicalTrials.gov ID
- NCT05180110
- Acronym / sponsor ID
- REACT / S-CLIN-PROT-00008
- Conditions
- Inflammation, Infections, Tissue Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- LumiraDx UK LimitedIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 11 Jan 2022 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a performance evaluation study designed to assess the precision and accuracy of the LumiraDx point of Care (POC) C-reactive Protein (CRP) test when used in patients presenting with symptoms of infection, tissue injury or inflammatory disorder.
The LumiraDx POC CRP test is a quantitative immunoassay providing results in under 10 minutes. The accuracy of the LumiraDx POC CRP test will be assessed using capillary whole blood, venous blood, and plasma samples, by comparison to the CRP results obtained from the same individuals as analysed by trained laboratory professionals using the reference device, Siemens Dimension Xpand Plus CRP assay. The results of this study are intended to be used for regulatory filings for use as an in vitro diagnostic test in the UK, European Union (EU) and other relevant geographies.
Adults (aged 18 and over at time of consent) presenting to the study sites with symptoms of infection, tissue injury or inflammatory disorder will be included in the study. Approximately 250 patients will be recruited to ensure that sufficient suitable patients are enrolled and to allow for a small level of exclusions.
After obtaining informed consent, blood tube samples will be drawn and fingerstick samples of capillary blood will be taken from the subject, these will be applied directly onto unique test strips for immediate measurement of CRP on the LumiraDx POC instrument.
The CRP results obtained via the LumiraDx CRP test will be used in a set of comparative analyses designed to determine the performance characteristics of the test. This study is an observational, cross-sectional design. As an observational study of an investigative device, results obtained during the course of the study will not inform or alter patient management or treatment decisions in any way.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptoms of inflammation, Infection, tissue injury | – | Diagnostic Test: Venepuncture, Diagnostic Test: FingerstickVenous blood draw of up to 24mL and up to 6 capillary fingersticks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenepunctureVenous blood draw | Diagnostic test | Symptoms of inflammation, Infection, tissue injury |
| FingerstickCapillary blood draw | Diagnostic test | Symptoms of inflammation, Infection, tissue injury |
Primary outcome
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.
Time frame: 2 months
Measurement of blood samples from patients with symptoms of inflammation, infection or injury in a reference method and in the LumiraDx method to assess accuracy of the LumiraDx method
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alasdair Gray, MD principal investigator
NHS Lothian
James Harnett principal investigator
University College London Hospital NHS Foundation Trust
Phil Moss principal investigator
St Georges University Hospitals NHS Foundation Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation and Infections, run by LumiraDx UK Limited at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.