Application of a bedside whole blood D-dimer assay in the diagnosis of deep vein thrombosis.
Cross-linked fibrin degradation products have been used to detect venous thrombosis. While the sensitivity of plasma D-dimer measured by ELISA in the diagnosis of deep vein thrombosis (DVT) is high, the utility of ELISA methods is limited in a clinical setting. This study analysed the diagnostic value of a rapid D-dimer assay performed on whole blood samples (SimpliRed D-dimer) compared with latex and ELISA in 86 patients suspected of having DVT. SimpliRed D-dimer was positive in 47/50 of patients with DVT established by Doppler ultrasound (DU; sensitivity 94%). SimpliRed D-dimer was positive in 35/37 of patients with proximal DVT, nine out of nine with popliteal DVT and three out of four with superficial thrombophlebitis. The specificity of SimpliRed D-dimer in the diagnosis of DVT was 61%. The sensitivity of the SimpliRed D-dimer assay was at least comparable with the ELISA (87%) and superior to the latex assay (80%). The positive predictive value (77%), the negative predictive value (88%) and the overall accuracy (80%) of the SimpliRed assay were better than the ELISA and latex methods. It is concluded that SimpliRed D-dimer is a rapid useful assay for screening of patients suspected of having deep vein thrombosis.
Brenner
B
B
Thrombosis and Hemostasis Unit, Rambam Medical Center, and Faculty of Medicine, Technion, Haifa, Israel.
Pery
M
M
Lanir
N
N
Jabareen
A
A
Markel
A
A
Kaftori
J K
JK
Gaitini
D
D
Rylatt
D
D
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004797:Enzyme-Linked Immunosorbent Assay; D005069:Evaluation Studies as Topic; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D005342:Fibrinolysis; D006801:Humans; D007841:Latex Fixation Tests; D008875:Middle Aged; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013924:Thrombophlebitis / Q000097:blood / Q000175:diagnosis* / Q000000981:diagnostic imaging; D014463:Ultrasonography
D005338:Fibrin Fibrinogen Degradation Products; D011933:Reagent Kits, Diagnostic; C036309:fibrin fragment D