Inflammation Clinical Trial
— REACTOfficial title:
A Performance Evaluation of the LumiraDx Point of Care CRP Assay.
Verified date | December 2023 |
Source | LumiraDx UK Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 79 |
Est. completion date | May 30, 2023 |
Est. primary completion date | January 11, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Infirmary Edinburgh | Edinburgh | |
United Kingdom | St Georges Hospital | London | |
United Kingdom | University College London Hospital | London |
Lead Sponsor | Collaborator |
---|---|
LumiraDx UK Limited |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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