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Am. J. Respir. Crit. Care Med., Volume 158, Number 1, July 1998, 65-70

Evaluation of a New, Rapid, and Quantitative D-Dimer Test in Patients with Suspected Pulmonary Embolism

EMMANUEL OGER, CHRISTOPHE LEROYER, LUC BRESSOLLETTE, MICHEL NONENT, EMMANUELLE LE MOIGNE, YVES BIZAIS, JEAN AMIRAL, MARC GRIMAUX, JEAN CLAVIER, PATRICK ILL, JEAN-FRANÇOIS ABGRALL, and DOMINIQUE MOTTIER

Department of Internal Medicine and Chest Diseases, Department of Radiology, Department of Biophysics, and Department of Haematology, CHRU de la Cavale Blanche, Brest; Serbio Research Laboratory, Gennevilliers; and Rhône-Poulenc-Rorer Laboratories, Montrouge, France

Previous studies have suggested the utility of D-Dimer ELISA assays in eliminating a diagnosis of pulmonary embolism (PE). Our objectives were to evaluate the performance of a new, rapid, quantitative, and automated Liatest D-Dimer Assay in patients with suspected PE. Three hundred 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. Diagnosis 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 ELISA (Asserachrom DDi), assays, were assessed at the end of the study. Among the 386 patients tested, 146 (37.8%) were classified as PE-positive. Liatest D-Dimer assay had a 100% sensitivity (95% confidence interval, 97 to 100%) and a negative predictive value of 100% (95% confidence 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 agreement between Liatest D-Dimer and Asserachrom DDi analyses. These findings suggest that this rapid, quantitative, and automated D-Dimer assay provides a useful diagnostic tool for the clinician with regard to exclusion of PE.




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