Multicenter analytical performance evaluation of the ST Genesia thrombin generation system

Area of Science:

• Clinical Chemistry
• Hematology
• Diagnostic Assay Development

Background:

• Thrombin generation (TG) assays show promise for clinical use but require validation in multicenter studies.
• Standardization and analytical performance assessment are crucial for adopting TG assays in clinical practice.

Purpose of the Study:

• To evaluate the analytical performance of the ST Genesia system with STG-ThromboScreen, STG-BleedScreen, and STG-DrugScreen reagents across three centers.
• To assess the suitability of the ST Genesia for multicenter clinical trials.

Main Methods:

• Repeatability and reproducibility were assessed using commercial plasmas and quality control (QC) samples.
• Accuracy was determined by calculating QC biases against manufacturer values.
• Inter-center agreement was evaluated by comparing TG parameters from healthy donors and patient samples across two French centers.

Main Results:

• Repeatability and reproducibility coefficients of variation (CVs) were below 5% and 10%, respectively, falling under 6% after normalization.
• Mean QC biases were less than 5% for most TG parameters.
• Good agreement was observed between centers for most TG parameters, with relative bias below 5%, except for specific parameters with STG-ThromboScreen.

Conclusions:

• The ST Genesia system demonstrates satisfactory repeatability, reproducibility, accuracy, and inter-laboratory variability for TG assays.
• The analytical performance supports the use of the ST Genesia in multicenter clinical trials for various diagnostic applications.