A NEW QUANTITATIVE D-DIMER ASSAY APPROPRIATE IN EMERGENCY - RELIABILITY OF THE ASSAY FOR PULMONARY-EMBOLISM EXCLUSION DIAGNOSIS

Plasma D-dimers, degradation products of crosslinked fibrin, are eleva ted in several thrombotic diseases. In the last decade, their measurem ent has been performed with specific monoclonal antibody based ELISA a ssay, with a high negative predictive value of such pathologies. Howev er these methods have a low clinical impact since they cannot be used in emergency because they are time consuming and require series. Recen tly, rapid tests have been proposed with similar accuracy and are feas ible for use in emergency conditions. The aim of our study was to eval uate the potential value of a new quantitative rapid assay, based on a gglutination of latex microparticles coated with two monoclonal antibo dies specific for D-dimers (Liatest D-Di, Diagnostica Stage), in the e xclusion diagnosis of pulmonary embolism (PE), Eighty-five consecutive suspected PE patients were included in the study, D-dimer determinati on was performed with both standard ELISA and Liatest D-Di just before pulmonary scintigraphy. Sixty-nine patients were free of PE and 16 ha d PE, Our results confirm the excellent sensitivity and negative predi ctive values of the conventional D-dimer ELISA. Using a cut-off value of 500 ng/ml, the sensitivity and the negative predictive values of Li atest D-Di were 94% and 96%, respectively. Only one case of PE had a D -dimer value at 480 ng/ml, close to the cut-off value. This study demo nstrates that the Liatest D-Di assay is sensitive enough to be used as the first step in the assessment of PE, However, the best cut-off val ue has to be determined to get an exclusion diagnosis with certainty. (C) 1998 Elsevier Science Ltd.