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Completed NCT04375982

Evaluation of the LumiraDx Point of Care D-Dimer and CRP Tests

Conditions: Embolism and Thrombosis, Infection, Inflammation

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 111
Sponsor: LumiraDx UK Limited

Location: Rancho Paseo Medical Group Banning California

Summary

A Multicenter Study Conducted to Evaluate the Agreement between Fingerstick Whole Blood, Venous Whole Blood and Plasma Determined on the LumiraDx Point of Care D-Dimer and Point of Care CRP Tests to Results on the Reference Analyzer

Eligibility Criteria

Inclusion Criteria D-dimer: * Subjects \>18 years of age. * Willing and able to provide written informed consent and comply with study procedures. * Presenting to healthcare provider for any reason\* \*All presentations are suitable for recruitment; however, the following conditions are of particular interest: Venous thromboembolism symptoms (DVT and Pulmonary embolism), subjects seeking medical attention with symptoms of respiratory tract infection (upper or lower), Acute myocardial infarction / unstable angina, Anti-inflammatory medication (current), Any regular medication for a chronic condition (other than simple painkiller or inhaler), Atrial fibrillation, Diabetes mellitus (all types except 'pre-diabetes'), Heart failure, Hypertension (\>150/90), Infection (significant current or within 3 months), Peripheral arterial disease, Surgery (within 6 weeks), Childbirth (within 8 weeks), Significant trauma, burns (within 4 weeks), Pregnancy (confirmed or suspected), Acute upper gastrointestinal haemorrhage other significant recent haemorrhage. D-dimer Exclusion Criteria: * The subject 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. * End-stage renal failure on haemodialysis. * Life expectancy documented as less than 30 days. * Haemodynamically unstable (e.g. cardiogenic shock). * Current anticoagulation therapy (Fragmin, LMWH) within the last 30 days. * Patients taking anticoagulant therapy (DOACS, Warfarin, Heparins etc.) within the last 30 days. * The subject has previously participated in this research study CRP Inclusion criteria: * Subjects \>18 years of age. * Willing and able to provide written informed consent and comply with study procedures. * Subjects seeking medical attention with symptoms of infection, tissue injury, inflammatory disorders or associated disease. This includes but not limited to: respiratory tract infection (upper or lower), rheumatoid arthritis, Lupus, burns, trauma, inflammatory bowel disease. CRP Exclusion Criteria: * The subject 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. * A subject with a critical illness, requiring critical intervention, or end of life or palliative care. * Subjects suffering with Myeloma, Monoclonal Gammopathy or extreme Lipaemia. * The subject has previously participated in this research study

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04375982). StuddyBuddy aggregates publicly available trial information.