A Performance Evaluation of the LumiraDx Point of Care CRP Assay
REACT
1 other identifier
interventional
79
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2021
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 25, 2021
CompletedFirst Submitted
Initial submission to the registry
December 17, 2021
CompletedFirst Posted
Study publicly available on registry
January 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2023
CompletedDecember 19, 2023
December 1, 2023
2 months
December 17, 2021
December 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
2 months
Study Arms (1)
Symptoms of inflammation, Infection, tissue injury
EXPERIMENTALVenous blood draw of up to 24mL and up to 6 capillary fingersticks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Royal Infirmary Edinburgh
Edinburgh, United Kingdom
St Georges Hospital
London, United Kingdom
University College London Hospital
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alasdair Gray, MD
NHS Lothian
- PRINCIPAL INVESTIGATOR
James Harnett
University College London Hospital NHS Foundation Trust
- PRINCIPAL INVESTIGATOR
Phil Moss
St Georges University Hospitals NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2021
First Posted
January 6, 2022
Study Start
November 25, 2021
Primary Completion
January 11, 2022
Study Completion
May 30, 2023
Last Updated
December 19, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share