VIDAS(R) D-DIMER - FAST QUANTITATIVE ELISA FOR MEASURING D-DIMER IN PLASMA

VIDAS D-dimer (bioMerieux) is a new quantitative ELISA for D-dimer det ermination designed for the VIDAS automated system. The test contains single-dose, ready-to-use reagents and is completed within 35 min. Qua ntitative results are obtained from a calibration curve stored in the software of the system and expressed as fibrinogen equivalent units. T he two-step capture/tag test relies on two complementary monoclonal an ti-D-dimer antibodies, the second one being labeled with alkaline phos phatase. The upper limit of the measuring range is 1000 mu g/L and the lower detection limit is <50 mu g/L, which is below the lower limit o f the reference interval (68-494 mu g/L). Reproducibility (CV) within and between runs ranges from 5% to 7%. There is no interference from h eparin, bilirubin, hemoglobin, fibrinogen degradation products, or pla sma turbidity. Comparison with a conventional ELISA (y) gave good corr elation (r = 0.91, n = 579) and comparable results (y = 1.35x - 148, S -y/x = 750), especially for D-dimer concentrations ranging from 0 to 1 000 mu g/L (y = 1.09x - 10.6, r = 0.88, S-y/x = 170).