D-dimers (DDi) arise from the degradation of fibrin by plasmin. Precise measurement of their levels is essential for managing the risk of venous thromboembolism in ambulatory patients or in monitoring disseminated intravascular coagulation. Indeed, it makes it possible to identify excessive coagulation or degradation of clots.

A new Stago automaton evaluated

Stago designed a new assay that uses monoclonal antibodies adsorbed onto latex particles, sthemO DDi M, to measure DDi levels on the sthemO 301 analyzer. Amarok Biotechnologies performed the analytical performance evaluation of the assay, in accordance with Clinical and Laboratory Standards Institute (CLSI) guidelines.

Our analytical performance tests

The results show that the test has a good measurement range, with linearity established across multiple batches and analyzers. The consistency between repeatability and reproducibility coefficients of variation reveals high precision. We have also developed a specific algorithm to automatically manage the dose-binding effect (up to very high concentrations). It appears that sthemO DDi M shows good stability under different storage conditions and after several test cycles.

Good prospects for the sthemO DDi M test

The performance of the sthemO DDi test on the sthemO analyzer confirms its interest for the quantification of D-dimers in human citrated plasma. Our laboratory is proud to contribute to the provision of precise and reliable tools for medical diagnosis!