[The diagnosis of deep venous thromboses of the leg using a new rapid test (SimpliRED)].
OBJECTIVE
Evaluation of sensitivity and specificity of a bed-side test in the diagnosis of deep-vein thrombosis compared to contrast phlebography.


METHODS
122 patients, referred for phlebography, underwent bedside testing (SimpliRED) for detection of deep vein thrombosis. Contrast phlebography was confirmed immediately afterwards. SimpliRED provides a clearly visible agglutination of the patient's red blood cells in the presence of elevated levels of crosslinked fibrin derivatives (D-dimer) in the sample, being specific for fibrin breakdown.


RESULTS
In 37 (30.3%) patients deep vein thrombosis could be confirmed. An abnormal D-dimer test was found in 35 of the 37 patients with thrombosis (sensitivity: 94.6%). Two patients who had not been identified by agglutinin testing, showed an isolated calf thrombosis in small muscle veins (< 2 cm in diameter) not requiring treatment. 55 of 85 patients without thrombosis in phlebography were stated correctly by SimpliRED (specificity: 64.7%).


CONCLUSIONS
All thrombotic disorders in the leg with the need for further treatment were identified correctly. SimpliRED is a very sensitive test with moderate specificity in the diagnosis of deep vein thrombosis. Therefore, further invasive 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 coagulation system is activated in several other conditions.
Wildberger
J E
JE
Klinik für Radiologische Diagnostik, Universitätsklinikum, RWTH Aachen.
Vorwerk
D
D
Kilbinger
M
M
Lentner
A
A
Wienert
V
V
Günther
R W
RW
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers / Q000097:blood; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis; D006403:Hematologic Tests / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D010690:Phlebography; D019095:Point-of-Care Systems; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D013924:Thrombophlebitis / Q000175:diagnosis*
D015415:Biomarkers; D005338:Fibrin Fibrinogen Degradation Products; C036309:fibrin fragment D