The LumiraDx D-Dimer Test is an in vitro diagnostic test quantitative determination of D-Dimer in human whole blood (capillary finger prick and sodium citrated venous) and sodium citrated plasma samples.  The Test can be used as an aid in the assessment and diagnosis of patients with suspected venous thromboembolism (VTE) such as deep vein thrombosis (DVT) and pulmonary embolism (PE).

The LumiraDx D-Dimer Test is a fluorescence immunoassay for use on the LumiraDx Platform.

The quantitative Test measures D-Dimer in human whole blood (including direct fingerstick) and plasma samples

Specification:

• Displayed results:   D-Dimer FEU (Fibrinogen Equivalent Units) μg/L
•  Storage temperature:   2–30 °C (36-86 °F)
• Operating temperature:  15–30 °C (59–86 °F)
• Measuring range:  190–4000 μg/L FEU
• Each laboratory should investigate the transferability of the expected values to its own patient population and, if necessary, determine its own reference ranges.
•  Sample size:   15 μL
•  Time to result:   Approximately 6 minutes
•  D-Dimer kit:   12 tests

Materials required but not provided with the Test Strip carton:

·       LumiraDx Instrument

·       LumiraDx D-Dimer Quality Controls (as required to meet local and organizational compliance)