WHOLE-BLOOD IMMUNOASSAY (SIMPLIRED(R)) VERSUS PLASMA IMMUNOASSAY (NYCOCARD(TM)) FOR THE DIAGNOSIS OF CLINICALLY SUSPECTED DEEP-VEIN THROMBOSIS

Background: The level of D-dimer in the blood reflects the level of ly sed, cross-linked fibrin, and is a useful diagnostic marker in patient s with clinically suspected deep vein thrombosis (DVT). In this study, two assays for the measurement of D-dimer levels were compared: the n ew, whole-blood immunoassay, SimpliRED(R), which can be performed at t he patient's bedside in two minutes; and the plasma immunoassay, NycoC ard(TM). Patients and methods: D-dimer levels were determined using th ese two techniques in 108 patients with clinicially suspected DVT. To ascertain or rule out the diagnosis of DVT compression ultrasonography using a colour coded Duplex instrument was done. 8 doubtful cases wer e diagnosed by ascending phlebography. By these procedures DVT was con firmed in 33 patients and ruled out in the remaining 75 cases. Results : The SimpliRED(R) assay exhibited a sensitivity of 1,0 (CI 0,89-1,0) and a specificity of 0,75 (CI 0,63-0,84); negative predictive value I, 0 (CI 0,94-1,0), positive predictive value 0,63 (CI 0,49-1,0). By cont rast, the NycoCard(TM) assay displayed a sensitivity of 0,85 (CI 0,68- 0,95) and a specificity of 0,65 (CI 0,53-0,76); negative predictive va lue 0,91 (CI 0,80-0,97), positive predictive value 0,52 (CI 0,38-0,66) . Conclusion: The results show that the SimpliRed(R) assay is a valuab le tool in the diagnosis of clinically suspected DVT, especially when laboratory facilities are not accessible.