A Performance Evaluation of the LumiraDx Point of Care CRP Assay
NCT ID: NCT05180110
Last Updated: 2023-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
79 participants
INTERVENTIONAL
2021-11-25
2023-05-30
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Symptoms of inflammation, Infection, tissue injury
Venous blood draw of up to 24mL and up to 6 capillary fingersticks
Venepuncture
Venous blood draw
Fingerstick
Capillary blood draw
Interventions
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Venepuncture
Venous blood draw
Fingerstick
Capillary blood draw
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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LumiraDx UK Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Alasdair Gray, MD
Role: PRINCIPAL_INVESTIGATOR
NHS Lothian
James Harnett
Role: PRINCIPAL_INVESTIGATOR
University College London Hospital NHS Foundation Trust
Phil Moss
Role: PRINCIPAL_INVESTIGATOR
St Georges University Hospitals NHS Foundation Trust
Locations
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Royal Infirmary Edinburgh
Edinburgh, , United Kingdom
St Georges Hospital
London, , United Kingdom
University College London Hospital
London, , United Kingdom
Countries
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Other Identifiers
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S-CLIN-PROT-00008
Identifier Type: -
Identifier Source: org_study_id