P. Demoerloose et al., CONTRIBUTION OF A NEW, RAPID, INDIVIDUAL AND QUANTITATIVE AUTOMATED D-DIMER ELISA TO EXCLUDE PULMONARY-EMBOLISM, Thrombosis and haemostasis, 75(1), 1996, pp. 11-13
The performance of a new automated ELISA for a rapid, individual and q
uantitative measurement of plasma D-dimer (VIDAS D-dimer) has been eva
luated. First, a study of 100 patients was performed in order to choos
e the best couple of antibodies in comparison with an already clinical
ly validated ELISA. Then the results were certified in a prospective s
tudy including 195 consecutive patients suspected of pulmonary embolis
m (PE). For a cut-off level of 500 ng/ml VIDAS D-dimer showed a sensit
ivity of 100% (95% confidence interval 92-100), a specificity of 37.6%
, a negative predictive value of 100% (95% CI 93.3-100) and a positive
predictive value of 33.1%. During a 6 months' follow-up no patient (9
5% CI 0-6.4) with D-dimer < 500 ng/ml presented a new suspicion of ven
ous thromboembolic disease. These results suggest that this rapid and
single-dose ELISA provides a very useful tool for the clinician to exc
lude on a day-to-day basis the diagnosis of PE.