Evaluation of a new, rapid, and quantitative D-dimer test in patients with suspected pulmonary embolism

• Published in: American journal of respiratory and critical care medicine 1998-07, Vol.158 (1), p.65-70
• Main Authors: OGER, E, LEROYER, C, ABGRALL, J.-F, MOTTIER, D, BRESSOLLETTE, L, NONENT, M, LE MOIGNE, E, BIZAIS, Y, AMIRAL, J, GRIMAUX, M, CLAVIER, J, ILL, P
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Algorithms; Biological and medical sciences; Enzyme-Linked Immunosorbent Assay; Evaluation Studies as Topic; Female; Fibrin Fibrinogen Degradation Products; Fibrin Fibrinogen Degradation Products - analysis; Human health and pathology; Humans; Immunoenzyme Techniques; Investigative techniques, diagnostic techniques (general aspects); Life Sciences; Male; Medical sciences; Middle Aged; Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques; Predictive Value of Tests; Prospective Studies; Pulmonary Embolism; Pulmonary Embolism - diagnosis; Respiratory system; Sensitivity and Specificity
• ISSN: 1073-449X; 1535-4970
• DOI: 10.1164/ajrccm.158.1.9710058

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.