A rapid and quantitative D-Dimer assay in whole blood and plasma on the point-of-care PATHFAST analyzer

• Published in: Thrombosis research Vol. 120; no. 5; pp. 695 - 701
• Main Authors: Fukuda, Teruko, Kasai, Hidetoshi, Kusano, Takeo, Shimazu, Chisato, Kawasugi, Kazuo, Miyazawa, Yukihisa
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Ltd 2007; Elsevier Science
• Subjects: Adult; Aged; Aged, 80 and over; Biological and medical sciences; Blood and lymphatic vessels; Blood Chemical Analysis - methods; Brain; Cardiology. Vascular system; Chemiluminescent immunoassay; Chemistry, Clinical - methods; Coronary heart disease; D-Dimer; Deep-vein thrombosis; Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous; Female; Fibrin Fibrinogen Degradation Products - biosynthesis; Fibrin Fibrinogen Degradation Products - metabolism; Heart; Hematology, Oncology and Palliative Medicine; Heparin - chemistry; Humans; Investigative techniques of hemodynamics; Investigative techniques, diagnostic techniques (general aspects); Male; Medical sciences; Middle Aged; Plasma - metabolism; Point-of-care testing; Predictive Value of Tests; Reference Values; Venous Thrombosis - blood; Venous Thrombosis - diagnosis; CUS; positive predictive value; point-of-care testing; DVT; CI; ROC; area under the curve; D-Dimer; AUC; NPV; POCT; PPV; enzyme-linked immunosorbent assay; FEU; deep-vein thrombosis; compression ultrasonography; confidence interval; receiver operating characteristic; Chemiluminescent immunoassay; negative predictive value; ELISA; fibrinogen equivalent unit; Point-of-care testing; Deep-vein thrombosis; Human; Lower limb; Deep vein thrombosis; Deep-vein thrombosis Point-of-care testing; Cardiovascular disease; D dimer; Enzyme immunoassay; Venous disease; Vascular disease; Reproducibility; Echography; Predictive value; Computerized axial tomography; Diagnosis
• ISSN: 0049-3848; 1879-2472
• DOI: 10.1016/j.thromres.2006.12.021

Abstract The objective of this study was to evaluate the accuracy indices of the new rapid and quantitative PATHFAST D-Dimer assay in patients with clinically suspected deep-vein thrombosis (DVT). Eighty two consecutive patients (34% DVT, 66% non-DVT) with suspected DVT of a lower limb were tested with the D-Dimer assay with a PATHFAST analyzer. The diagnostic value of the PATHFAST D-Dimer assay (which is 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 tomography, 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. The correlation between the results of PATHFAST D-Dimer and VIDAS D-Dimer was acceptable ( y = 1.134 × + 0.003, r = 0.902). The test reproducibility was good (CV%: from 4.0% to 5.0% for plasma and from 7.1% to 7.5% for whole blood) and the total imprecision was very good (CV%: 3.6–5.7%). Whole blood as well as plasma can be used as samples in this assay ( y = 1.013 × − 0.010, r = 0.971 for heparinized specimens; y = 1.068 × + 0.003, r = 0.989 for citrated specimens). Because of its high sensitivity and NPV PATHFAST D-Dimer assay can be useful for the rapid rule out of DVT in patients admitted with suspected thrombosis.