Rapid cardiovascular disease test

D-dimerplasmawhole blood

The LumiraDx D-Dimer Test is an easy to use, fast microfluidic immunoassay designed to rapidly quantify D-Dimer levels in whole blood and plasma. It is the only direct fingerstick D-Dimer assay available today*, aiding healthcare professionals to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) in symptomatic patients with confidence** - in only 6 minutes. The LumiraDx D-Dimer Test is an in vitro diagnostic test for the quantitative determination of D-Dimer in human capillary and venous whole blood and plasma samples (Sodium Citrate). The LumiraDx D-Dimer Test Strips are intended for use with the LumiraDx Instrument. It is an automated in vitro diagnostic test for near-patient testing to aid in the assessment and diagnosis of patients with suspected venous thromboembolism (VTE) such as deep vein thrombosis (DVT) and pulmonary embolism (PE). The test can be used in conjunction with a clinical pre-test probability assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) disease in patients suspected of DVT or PE. The LumiraDx D-Dimer test is for Professional Use Only. For patients ≥18 years of age. Test benefits The LumiraDx D-Dimer Test improves efficiency in primary and secondary care settings by offering a rapid assessment of patients presenting with symptoms of deep vein thrombosis (DVT) and pulmonary embolism (PE). Clinical Cut-off: 500 µg/L FEU, 0.500 mg/L FEU Direct fingerstick sampling Room temperature Test Strip storage Precision: ≤11.1% CV Test workflow The Instrument and Test Strips are integrated with several quality control checks to ensure the Instrument and test are functioning correctly for every test run.