PB1025 - Evaluation of a new Stago system for D-dimer levels determination: sthemO DDi on sthemO 301

Background: D-Dimers (DDi) are the terminal products of fibrin degradation by plasmin. An increase in plasma DDis indicates activation of the coagulation and fibrinolysis systems or the presence of a thrombus. Thus, the DDi assay is used in several clinical situations such as the exclusion of pulmonary embolism (PE) and deep vein thrombosis (DVT) in association with a clinical score, or as an aid in the diagnosis and monitoring of DIC (Disseminated intravascular coagulation). Many DDi assay methods have been developed: qualitative, quantitative ELISA, ELFA or immunoturbidimetric using antibodies monoclonal antibodies adsorbed on latex particles. A new reagent using immunoturbidimetric measurements, sthemO DDi, has been designed to perform quantitative DDi measurement on a new laboratory equipment from Diagnostica Stago: sthemO 301.

Aims: The objective of this study was the validation of the analytical performance of sthemO DDi on sthemO 301, for its intended use by performing a comparison with STA® – Liatest® D-Di PLUS on STA-R Max®.

Methods: This study was performed in three different centers. Normal and pathologic Quality Controls (QCs) were tested at the beginning and at the end of each run during sample testing to validate the runs on both the instruments.

The study populations for this method comparison study are described in table1.

Results: For sthemO DDi, coefficients of variation (CV) of QCs, performed in the three centers, were between 0.9% and 4.5% and between 1.2% and 5.0 % for STA® – Liatest® D-Di PLUS. All the QC’s were within the acceptance criteria according to CLSI H59.

Results of comparison are described in Passing Bablok representation in the figure 1.

Conclusion(s): This study demonstrates the analytical equivalent performance of the sthemO DDI system versus the STA® – Liatest® D-Di PLUS.