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Evaluation of the analyzer ST Genesia
Annales De Biologie Clinique
|June 29, 2022
Summary
The ST Genesia® device offers a fully automated thrombin generation test (TG) for evaluating bleeding and clotting risks. This study establishes its usability and normal values, particularly for pediatric patients, paving the way for clinical use.
Area of Science:
- Hematology
- Clinical Chemistry
Background:
- Thrombin generation (TG) testing aids in assessing hemorrhagic and thrombotic risks.
- The ST Genesia® is a fully automated, benchtop device for TG analysis.
- Standardization and establishment of reference values are crucial for routine laboratory implementation.
Purpose of the Study:
- To evaluate the ST Genesia® automated TG analyzer.
- To determine reference values for the ST Genesia®, with a focus on the pediatric population.
Main Methods:
- Evaluation of BleedscreenTM and ThromboscreenTM reagents on the ST Genesia®.
- Assessment of precision, stability, practicability, and age-specific reference values.
- Comparison with the calibrated automated thrombogram (CAT) method, analyzing TG parameters (ETP, peak, velocity, lag time, time to peak) normalized to reference plasma.
Main Results:
- Both reagents demonstrated excellent precision (CV < 5%) for repeatability and reproducibility.
- No significant differences were observed between fresh and frozen samples.
- Age- and sex-specific reference values were established, including for pediatric cohorts.
Conclusions:
- The ST Genesia® offers a standardized, automated platform for TG testing with precise temperature control and normalized results.
- This validation study is essential for the future clinical application of the ST Genesia® system.
