Performance of a new, fast D-dimer test (IL Test (TM) D-Dimer) for the management of outpatients with suspected deep vein thrombosis in emergency situations

Objective: To evaluate a new, rapid, quantitative and automated test for D- dimer measurement, the IL Test(TM) D-Dimer, in outpatients with clinically suspected acute deep vein thrombosis (DVT). Design: Evaluation of the resul ts of D-dimer test vs venography as reference test. Subjects: Ninety-two co nsecutive symptomatic outpatients with a first episode of suspected DVT wer e included in the study. Venography was performed in all patients. Setting: University Hospital. Results: DVT was diagnosed in 35 patients (31 proxima l). Sensitivity and negative predictive value of the IL Test(TM) D-Dimer we re both 100% at a cut-off level of 230 ng/ml; corresponding specificity and positive predictive value were 77.2 and 72.9% respectively. The between-as say reproducibility was very good (CV% range: 4.1-6.2). Conclusions: The te st proved rapid, automated and with a high sensitivity and negative predict ive value for DVT. The method can be evaluated in prospective clinical tria ls to test its usefulness, in combination with other non-invasive diagnosti c procedures, in the management of DVT diagnosis.