PB0125 - Clinical performance evaluation of a new Stago system for Factor IX level determination: sthemO IX on sthemO 301

Background: Factor IX (FIX) of coagulation is an important factor of the activation of coagulation in the intrinsic way and, FIX deficiencies (hemophilia B) are associated with excessive and prolonged bleedings. The severity of hemophilia B is defined by the FIX coagulant activity (FIX:C) level: Severe hemophilia B ( < 1% or < 0.01 IU/mL), Moderate hemophilia B ([1 – 5]% or [0.01-0.05] IU/mL) and Mild hemophilia B (]5 – 40[% or ]0.05 - 0.40[ IU/mL). Then, the measurement of FIX:C should be accurate to assess the bleeding risk. A new reagent: sthemO IX has been designed to perform FIX:C assay on the new Diagnostica Stago analyzer sthemO 301.

Aims: The objective of this work was to validate the performance of sthemO IX on sthemO 301 analyzer, for its intended purpose by performing a comparison with STA® - ImmunoDef IX on STA-R Max®.

Methods: 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.
The study population for the method comparison is described in table 1.

Results:

Results: For sthemO IX QC’s, coefficients of variation (CV) were between 2.9 and 4.5% and between 3.7 and 4.1% for STA® - ImmunoDef IX. All QCs were within the acceptance criteria according to the GFHT “French hemostasis and thrombosis group” guidelines.
Results of comparison are described in Passing-Bablok representation in the following figure.

Conclusion(s): With all results meeting pre-defined acceptance criteria, sthemO IX is validated for its intended purpose.