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Completed
NCT05180110
A Performance Evaluation of the LumiraDx Point of Care CRP Assay
Conditions: Inflammation, Infections, Tissue Injury
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 79
Sponsor: LumiraDx UK Limited
Location: Royal Infirmary Edinburgh Edinburgh
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT05180110). StuddyBuddy aggregates publicly available trial information.