W. Mayer et al., WHOLE-BLOOD IMMUNOASSAY (SIMPLIRED(R)) VERSUS PLASMA IMMUNOASSAY (NYCOCARD(TM)) FOR THE DIAGNOSIS OF CLINICALLY SUSPECTED DEEP-VEIN THROMBOSIS, VASA, 26(2), 1997, pp. 97-101
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.