[Clinical usefulness of three quantitative D-dimers tests in outpatients with suspected deep vein thrombosis].

BACKGROUND AND OBJECTIVE

The diagnostic approach in outpatients with suspected deep vein thrombosis (DVT) of the lower limbs includes D-dimer measurement (DD). Elevated DD is not a diagnostic value for DVT. However, a normal value contributes to ruling out DVT. We do not know the best method to determine DD. Therefore, we have analyzed the clinical utility of three quantitative assays to determine DD in outpatients with suspected DVT.

PATIENTS AND METHODS

Consecutive outpatients with suspected DVT of the lower limbs who were referred to the DVT medical consultation were enrolled in the study. We used a diagnostic algorithm that included determining the pretest clinical probability (PCP) (Wells scale), DD level using three different quantitative methods (ELISA mini-VIDAS(®), Acure-care DDMR and DD-Plus). The DVT diagnosis was confirmed by seriated compression ultrasonography of the lower limbs. We analyzed the concordance between the three analytic methods to quantify DD and the characteristics.

RESULTS

A total of 306 patients (mean age 60 years, 62% women) with suspected DVT of the lower limbs were included. The compression ultrasonography confirmed the diagnosis of DVT in 23.8% of the patients. Anticoagulation treatment was not performed in patients in whom DVT was ruled out, and no thromboembolic event occurred during the 3 months of follow-up. The best concordance test results were between ELISA mini-VIDAS(®) and Acure-care DDMR assays. Both assays demonstrated elevated sensibility and a negative predictive value. ELISA mini-VIDAS(®) was the best analytic method for the subgroup of patients with low clinical probability.

CONCLUSIONS

The ELISA mini-VIDAS(®) method to determine DD rules out DVT in patients with low clinical probability.