EVALUATION OF A NEW, RAPID, AND QUANTITATIVE D-DIMER TEST IN PATIENTSWITH SUSPECTED PULMONARY-EMBOLISM

Previous studies have suggested the utility of D-Dimer ELISA assays in eliminating a diagnosis of pulmonary embolism (PE). Our objectives we re to evaluate the performance of a new, rapid, quantitative, and auto mated Liatest D-Dimer Assay in patients with suspected PE. Three hundr ed eighty-six consecutive patients referred to our institution between March 1992 and December 1996 for clinically suspected PE, with recent clinical signs not exceeding 1 wk, were included in this study. Diagn osis of PE was based on clinical evaluation, radionuclide lung imaging , lower limb examination, and, when required, pulmonary angiography. D -Dimer performances, for both Liatest D-Dimer and standard D-Dimer ELI SA (Asserachrom DDi), assays, were assessed at the end of the study. A mong the 386 patients tested, t46 (37.8%) were classified as PE-positi ve. Liatest D-Dimer assay had a 100% sensitivity (95% confidence inter val, 97 to 100%) and a negative predictive Value of 100% (95% confiden ce interval, 94 to 100%). A normal result, below the cutoff of 500 ng/ ml, occurred in 83 of the 386 (21%) patients. There was a strong agree ment between Liatest D-Dimer and Asserachrom DDi analyses. These findi ngs suggest that this rapid, quantitative, and automated D-Dimer assay provides a useful diagnostic tool for the clinician with regard to ex clusion of PE.