A Rapid and Quantitative D-Dimer Assay in Whole Blood and Plasma on the Point-Of-Care PATHFAST Analyzer ARTICLE in PRESS
MODEL 6 TR-03106; No of Pages 7 ARTICLE IN PRESS Thrombosis Research (2007) xx, xxx–xxx intl.elsevierhealth.com/journals/thre REGULAR ARTICLE A rapid and quantitative D-Dimer assay in whole blood and plasma on the point-of-care PATHFAST analyzer Teruko Fukuda a,⁎, Hidetoshi Kasai b, Takeo Kusano b, Chisato Shimazu b, Kazuo Kawasugi c, Yukihisa Miyazawa b a Department of Clinical Laboratory Medicine, Teikyo University School of Medical Technology, 2-11-1 Kaga, Itabashi, Tokyo 173-8605, Japan b Department of Central Clinical Laboratory, Teikyo University Hospital, Japan c Department of Internal Medicine, Teikyo University School of Medicine, Japan Received 11 July 2006; received in revised form 7 December 2006; accepted 28 December 2006 KEYWORDS Abstract The objective of this study was to evaluate the accuracy indices of the new D-Dimer; rapid and quantitative PATHFAST D-Dimer assay in patients with clinically suspected Deep-vein thrombosis; deep-vein thrombosis (DVT). Eighty two consecutive patients (34% DVT, 66% non-DVT) Point-of-care testing; with suspected DVT of a lower limb were tested with the D-Dimer assay with a Chemiluminescent PATHFAST analyzer. The diagnostic value of the PATHFAST D-Dimer assay (which is immunoassay based on the principle of a chemiluminescent enzyme immunoassay) for DVT was evaluated with pre-test clinical probability, compression ultrasonography (CUS). Furthermore, each patient underwent contrast venography and computed tomogra- phy, if necessary. The sensitivity and specificity of the D-Dimer assay using 0.570 μg/ mL FEU as a clinical cut-off value was found to be 100% and 63.2%, respectively, for the diagnosis of DVT, with a positive predictive value (PPV) and negative predictive value (NPV) of 66.7% and 100%, respectively.
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