PB1143 - Analytical Performance Evaluation of a New Stago System SthemO 201

Background: The sthemO 201 analyzer is compact and fully automated. It is specifically designed for in vitro diagnostic use for coagulation and/or fibrinolysis testing of human plasma by clotting, chromogenic and immunoassay methods.

Aims: Validation of the analytical performances of sthemO 201 analyzer by comparing it to the predicate analyzer sthemO 301.

Methods: We performed a method comparison analysis between the sthemO 201 and sthemO 301 analyzers. Three reagents were evaluated. 1) sthemO FIB, which measures fibrinogen levels using the Clauss clotting method, through mechanical clot detection; 2) sthemO FDP, which measures the level of fibrin degradation products (FDP) by an immunoturbidimetric method and 3) sthemO AT, which measures the activity level of antithrombin (AT) using a chromogenic assay. Leftover plasma samples and plasma samples from healthy individuals were used to perform this study. For collection of samples from healthy donors, approval from the medical ethical review committee azM/UM was obtained and donors signed an informed consent. For the leftover samples, patients underwent a blood draw for their regular care and no consent was needed. 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 instruments. Passing-Bablok regression analysis was performed to determine equivalence of the sthemO 201 to the sthemO 301.

Results: The coefficient of variation for the QCs ranged from 2.4% to 5.9% for QC 1 (normal level) and from 2.8% to 5.0% for QC 2 (pathological level), see Table 1. All the QC’s were within the acceptance criteria according to the GFHT “French hemostasis and thrombosis group” guidelines. For all reagents tested, the Passing-Bablok regression analysis was compliant with the acceptance criteria, see Figure 1.

Conclusion(s): The sthemO 201 analyzer is equivalent to its predicate device sthemO 301.