Je. Wildberger et al., NEWLY DEVELOPED BED-SIDE TEST (SIMPLIRED( R)) IN THE DIAGNOSTICS OF DEEP-VEIN THROMBOSIS, RoFo. Fortschritte auf dem Gebiete der Rontgenstrahlen und der neuenbildgebenden Verfahren, 167(1), 1997, pp. 79-82
Newly developed bed-side test (SimpliRED(R)) in the diagnostics of dee
p vein thrombosis. Purpose: Evaluation of sensitivity and specificity
of a bed-side test in the diagnosis of deep-vein thrombosis compared t
o contrast phlebography. Methods: 122 patients, referred for phlebogra
phy, underwent bedside testing (SimpliRED(R)) for detection of deep Ve
in thrombosis. Contrast phlebography was confirmed immediately afterwa
rds. SimpliRED(R) provides a clearly visible agglutination of the pati
ent's red blood cells in the presence of elevated levels of crosslinke
d fibrin derivatives (D-dimer) in the sample, being specific for fibri
n breakdown. Results: In 37 (30.3%) patients deep vein thrombosis coul
d be confirmed. An abnormal D-dimer test was found in 35 of the 37 pat
ients with thrombosis (sensitivity: 94.6%). Two patients who had not b
een identified by agglutinin testing, showed an isolated calf thrombos
is in small muscle veins (<2 cm in diameter) not requiring treatment.
55 of 85 patients without thrombosis in phlebography were stated corre
ctly by SimpliRED(R) (specificity: 64.7%). Conclusion: All thrombotic
disorders in the leg with the need for further treatment were identifi
ed correctly. SimpliRED(R) is a very sensitive test with moderate spec
ificity in the diagnosis of deep vein thrombosis. Therefore, further i
nvasive testing is needed only in such patients where the D-dimer test
is abnormal. A false positive result of the bed-side test may be non-
specific or due to elevated levels of fibrin split products, if the co
agulation system is activated in several other conditions.