Performance Evaluation of the VIDAS® D-Dimer Exclusion™ II Assay and the Beckman Coulter D-Dimer Assay.

ABSTRACT

BACKGROUND: The breakdown of fibrinogen and fibrin during the process of fibrinolysis creates D-dimer. A D-dimer analysis is crucial for the diagnosis of pulmonary embolism, deep vein thrombosis, and disseminated intravascular coagulation. The aim of this study is to evaluate the validity of two different D-dimer assays. METHODS: To analyze the D-dimer, venous blood taken in a vacuette containing 3.2% sodium citrate was used. Peripheral whole blood specimens were collected from 89 subjects, and plasma was separated from these specimens. VIDAS® D-dimer Exclusion™ II and the Beckman Coulter D-dimer assays were used for the quantitative detection of D-dimer levels. The analytical performance of the two different D-dimer assays was compared. RESULTS: The plasma values of D-dimer ranged from 89.2 to 7,452.9 ng/mL (FEU) when tested on the VIDAS® platform and from 20 to 7,770 ng/mL (FEU) when tested on the Beckman Coulter platform. Our results showed that the agreement between the two methods was acceptable and Pearson's correlation coefficient (r) was 0.93 (p < 0.001). CONCLUSIONS: A high correlation exists between quantitative D-dimer measurements conducted with the VIDAS® D-dimer Exclusion™ II and the Beckman Coulter D-dimer assays.