Thromb Haemost 1994; 71(03): 270-274
DOI: 10.1055/s-0038-1642428
Original Article
Schattauer GmbH Stuttgart

Comparison of Three D-Dimer Assays for the Diagnosis of DVT: ELISA, Latex and an Immunofiltration Assay (NycoCard D-Dimer)

Siri Dale
1  R & D-Unit, Diagnostics Division, Nycomed Pharma, AS, Oslo, Norway
,
Geir O Gogstad
1  R & D-Unit, Diagnostics Division, Nycomed Pharma, AS, Oslo, Norway
,
Frank Brosstad
2  Institute for Internal Medicine, The National Hospital, Oslo, Norway
,
Hans C Godal
3  Haematological Section, Ullevaal Hospital, Oslo, Norway
,
Jostein Holtlund
1  R & D-Unit, Diagnostics Division, Nycomed Pharma, AS, Oslo, Norway
,
Einar Mørk
1  R & D-Unit, Diagnostics Division, Nycomed Pharma, AS, Oslo, Norway
,
Øystein Brandsnes
1  R & D-Unit, Diagnostics Division, Nycomed Pharma, AS, Oslo, Norway
,
Stig M Borch
1  R & D-Unit, Diagnostics Division, Nycomed Pharma, AS, Oslo, Norway
› Author Affiliations
Further Information

Publication History

Received: 13 July 1993

Accepted after revision 17 December 1993

Publication Date:
06 July 2018 (online)

Summary

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 cutoff 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.