Comparison of three D-dimer assays for the diagnosis of DVT:ELISA, latex and an immunofiltration assay (NycoCard D-Dimer).
Ninety-two consecutive patients referred for suspicion of deep venous thrombosis (DVT) were analyzed for D-dimer using ELISA, latex test, and a new immunofiltration method (NycoCard D-Dimer). Contrast venography verified the diagnosis in 40, and excluded the diagnosis in 52 patients. The sensitivity, negative predictive values, specificity and positive predictive values were, for ELISA 98%, 95%, 38% and 54, for NycoCard D-Dimer 100%, 100%, 42% and 57% and for the latex test 73%, 78%, 75%, and 69%, respectively. Sensitivity and specificity were inversely related with increasing pathological cut-off value. Comparison of test results by concentration category revealed a good agreement between ELISA and NycoCard D-Dimer, but to less extent between latex and the two other tests. It is concluded that NycoCard D-Dimer and D-dimer ELISA are well-suited as exclusion tests for DVT. A plasma sample is tested with NycoCard D-Dimer in less than 2 min. Thus, this test combines advantageous analytical properties comparable to the ELISA-test, with rapidity and simplicity comparable to the latex test.
R&D-Unit, Nycomed Pharma AS, Oslo, Norway.
S
S
Dale
G O
GO
Gogstad
F
F
Brosstad
H C
HC
Godal
J
J
Holtlund
E
E
Mørk
O
O
Brandsnes
S M
SM
Borch
D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000276:immunology; D004797:Enzyme-Linked Immunosorbent Assay; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis* / Q000276:immunology; D005374:Filtration; D006801:Humans; D007150:Immunohistochemistry / Q000295:instrumentation; D007841:Latex Fixation Tests; D008875:Middle Aged; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013924:Thrombophlebitis / Q000097:blood / Q000175:diagnosis*
D000911:Antibodies, Monoclonal; D005338:Fibrin Fibrinogen Degradation Products; D011933:Reagent Kits, Diagnostic; C036309:fibrin fragment D