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

Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Hospital Universitario Virgen del Rocío, Sevilla, España.
Revista Clínica Española (Impact Factor: 1.06). 04/2012; 212(5):235-41.
Source: PubMed


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

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    ABSTRACT: The diagnosis of deep venous thrombosis (DVT) may be challenging due to the inaccuracy of clinical assessment and diversity of diagnostic tests. On one hand, missed diagnosis may result in life-threatening conditions. On the other hand, unnecessary treatment may lead to serious complications. As a result of an initiative of the Ministry of Health of the Kingdom of Saudi Arabia (KSA), an expert panel led by the Saudi Association for Venous Thrombo-Embolism (SAVTE; a subsidiary of the Saudi Thoracic Society) with the methodological support of the McMaster University Working Group, produced this clinical practice guideline to assist healthcare providers in evidence-based clinical decision-making for the diagnosis of a suspected first DVT of the lower extremity. Twenty-four questions were identified and corresponding recommendations were made following the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. These recommendations included assessing the clinical probability of DVT using Wells criteria before requesting any test and undergoing a sequential diagnostic evaluation, mainly using highly sensitive D-dimer by enzyme-linked immunosorbent assay (ELISA) and compression ultrasound. Although venography is the reference standard test for the diagnosis of DVT, its use was not recommended.
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