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 elevated in several thrombotic diseases. In the last decade, their measurement has been performed with specific monoclonal antibody based ELISA assay, with a high negative predictive value of such pathologies. However these methods have a low clinical impact since they cannot be used in emergency because they are time consuming and require series. Recently, rapid tests have been proposed with similar accuracy and are feasible for use in emergency conditions. The aim of our study was to evaluate the potential value of a new quantitative rapid assay, based on agglutination of latex microparticles coated with two monoclonal antibodies specific for D-dimers (Liatest D-Di, Diagnostica Stage), in the exclusion diagnosis of pulmonary embolism (PE), Eighty-five consecutive suspected PE patients were included in the study, D-dimer determination was performed with both standard ELISA and Liatest D-Di just before pulmonary scintigraphy. Sixty-nine patients were free of PE and 16 had PE, Our results confirm the excellent sensitivity and negative predictive values of the conventional D-dimer ELISA. Using a cut-off value of 500 ng/ml, the sensitivity and the negative predictive values of Liatest 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 demonstrates 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 value has to be determined to get an exclusion diagnosis with certainty. (C) 1998 Elsevier Science Ltd.