MiniQuant D-dimer: an instrument-reagent system for the rapid and accurate determination of D-dimer in plasma samples
Leiden, The Netherlands, 25-27 April 2001
CRP 2001 1:029
Annika Tovedal, Erika Wikberg and Anne-Sofie Carlström
Biopool AB, SE-903 47 Umeå, Sweden
ABSTRACT
Laboratory measurements of elevated levels of D-dimer have significance in screening for conditions like deep vein thrombosis (DVT), pulmonary embolism (PE) and disseminated intravascular coagulation (DIC).
The Biopool MiniQuant D-dimer is an assay system - comprising instrument and reagents - for the quantitative determination of D-dimer in citrated plasma. The assay is based on latex-enhanced immunoagglutination using the D-dimer specific monoclonal antibody MA8D3.
The assay is performed by adding a latex suspension to a reaction cuvette containing plasma dilution. The result is automatically obtained after 80 seconds of incubation in the instrument. A standard curve must be recorded for each new lot of reagents but can then be stored in the instrument.
The calibration range is 100-3.200 µg/L; however, the linearity of the method is very good up to approximately 5.000 µg/L. The detection limit is 75 µg/L and there is no prozone effect in samples containing less than 130.000 µg/L. In a study of normal individuals, 95% of the measured D-dimer values were below 250 µg/L. The intra-assay CV is < 8% for a control plasma containing 300 µg/L and < 6% for a plasma at 2000 g/L.
The MiniQuant D-dimer method shows good correlation with various Elisa methods as well as with other immunoturbidimetric methods; e.g., TintElize D-dimer (r2 = 0.95) and AutoDimer (r2 >0.98).
A recent clinical evaluation of the MiniQuant D-dimer method (Gosselin et al. Blood Coag Fibrinolysis 2000, 11: 715-721) demonstrated high sensitivity and negative predictive value (NPV) in the diagnosis of DVT and PE using 200 µg/L as cut-off (95% sensitivity and 94% NPV for DVT; 100% sensitivity and 100% NPV for PE). Since the MiniQuant D-dimer system provides a robust, easy-to-perform and accurate method with short total analysis time it should be well-suited for small to medium-sized laboratories as a tool for the exclusion of thromboembolism.
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PMID (PubMed - indexed for MEDLINE)