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Diagnostic value of a new sensitive membrane based technique for instantaneous D-dimer evaluation in patients with
C Leroyer1, M Escoffre, E Le Moigne
1Department of Chest Diseases and Internal Medicine, Hôpital de la Cavale Blanche, Brest, France.
Background:
Plasma D-Dimer analysis, using ELISA assays, has demonstrated in previous studies a high sensitivity, suggesting its utility in excluding deep venous thrombosis (DVT).
Aim:
To assess the performance of a new rapid plasma D-Dimer ELISA measurement in suspected DVT patients with recent clinical signs, not exceeding one week.
Methods:
A prospective study of patients admitted for a suspected recent DVT. Contrast venography or compression ultrasonography were performed within 24 h of admission. A new membrane based ELISA technique, which uses an immunofiltration and two complementary monoclonal antibodies was tested. Results were expressed as positive or negative. A standard plasma D-Dimer ELISA measurement was also performed. D-Dimer performances were assessed at the end of the study.
Results:
265/448 patients had a proven DVT (72 distal, 193 proximal). The sensitivity of the instantaneous method in the diagnosis of overall DVT is 92 +/- 3.4% (95% CI), and specificity is 36.6 +/- 6.9%. Positive predictive value is 67.7 +/- 4.8% and negative predictive value is 76.1 +/- 8.9%. Sensitivity and negative predictive values reach 97.9 and 94.3% in the diagnosis of proximal DVT, but only 76.3 and 79.7% in the diagnosis of distal DVT. Similar results are observed with the standard ELISA method.
Conclusion:
This new rapid plasma D-Dimer measurement appears highly sensitive, and could substitute the older ELISA methods. Both methods provide lower sensitivity in the case of a distal DVT location.