title: Diagnostic value of the Nycocard, Nycomed D-dimer assay for the diagnosis of deep venous thrombosis and pulmonary embolism: a retrospective study.
abstract: The relatively new D-dimer assay from Nycomed Pharma (Nycocard), which has shown both high sensitivity and specificity in diagnosing deep venous thrombosis (DVT) and pulmonary embolism (PE) in earlier studies, was re-evaluated retrospectively. The diagnostic value of the D-dimer assay for DVT was evaluated with contrast venography as reference. The diagnostic value of the D-dimer assay for PE was evaluated with pulmonary scintigraphy as reference. D-dimer tests were examined from 54 consecutive patients. The D-dimer assay was found to have a sensitivity and specificity of 50% and 58%, respectively, for the diagnosis of DVT, with a positive predictive value (PPV) and negative predictive value (NPV) of 55% and 54%, respectively. Using reference diagnostic results of high probability and low probability for the diagnosis of PE, the D-dimer test sensitivity and specificity was found to be 40% and 94%, respectively (PPV: 86%, NPV: 64%). The diagnostic value of the Nycocard(R) assay appears to be very limited for the diagnosis of DVT and PE. This retrospective study suggests that it is unsuitable as a screening method. Further re-evaluation of D-dimer assays is recommended prior to routine clinical use.
authors: Department of Cardiology, Frederiksberg University Hospital, Denmark. RikkeHein@dadlnet.dk
authors: R
authors: R
authors: Hein-Rasmussen
authors: C D
authors: CD
authors: Tuxen
authors: N
authors: N
authors: Wiinberg
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000933:Antifibrinolytic Agents / Q000378:metabolism; D015415:Biomarkers / Q000032:analysis; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000378:metabolism*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010690:Phlebography / Q000379:methods; D011237:Predictive Value of Tests; D011655:Pulmonary Embolism / Q000175:diagnosis*; D011877:Radionuclide Imaging; D011933:Reagent Kits, Diagnostic / Q000592:standards; D012189:Retrospective Studies; D020246:Venous Thrombosis / Q000175:diagnosis*
chemical_list: D000933:Antifibrinolytic Agents; D015415:Biomarkers; D005338:Fibrin Fibrinogen Degradation Products; D011933:Reagent Kits, Diagnostic; C036309:fibrin fragment D