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    Poster Networking

    Diagnostics and OMICs

    Poster Networking Session

    PB1162 - Precision Performances Evaluation of the Routine Hemostasis Tests Panel sthemO PT , sthemO PTT A, sthemO CK Prest, sthemO Fib and sthemO Thrombin on sthemO 301 Analyzer

    Tuesday, June 27, 2023
    18:30 – 19:30 ET
    Room: Exhibition
    Background: Prothrombin time (PT), (activated) partial thromboplastin time (APTT), fibrinogen (Fib) level determination through Clauss method and Thrombin time assays all belong to the routine hemostasis tests panel. As such, laboratories carryout most of these assays very frequently and their precision performance is critical to provide a valuable tests.

    Aims: The new Stago analyzer sthemO 301 is developed with new and dedicated application and reagents sthemO PT, sthemO PTT A, sthemO CK Prest, sthemO Fib and sthemO Thrombin.
    The aim of the study was to assess the intra site and inter site precisions of these applications according to the CLSI EP05-A3.

    Methods: The precision studies was conducted using the new Stago analyzer sthemO 301 on 3 sites on plasma samples covering the whole measuring range for each test.
    The intra site study is carried out over 20 days. A total of 3 lots and 3 analyzers were used.
    For the inter sites study, a total of 10 runs with 1 lot of each reagent on 3 sthemO 301.
    All reagents and analyzers were from Stago, France.

    Results: Intra-site precision for one lot/all lots combined and for all instruments combined was calculated from the intra-site study.
    Table 1 gives example of results obtained with sthemO PT.
    Inter-site precision for all instruments combined was calculated. Table 2 shows the results for sthemO Fib assay.
    The International Normalized Ratio was calculated from International Sensitivity Index of the lot (0.97) and from the Mean Normal Prothrombin Time of the lot (12.4 seconds)

    Conclusion(s): The reagents for routine tests on sthemO 301 are precise and reproducible over the whole range and the CV% results are in accordance with GFHT recommendations.
    The CV% obtained provide evidence that with the new Stago system (analyzer/reagents) will constitute a reliable support tool for the clinical laboratory.