Evaluation of the analyzer ST Genesia (R) and establishment of usual values with special attention to pediatric age

Background. Numerous studies have shown that thrombin generation test (TG) allows a better evaluation of the hemorrhagic and the thrombotic risks. The ST Genesia (R) is a benchtop, fully automated TG device. However, standardization of the technique and establishment of usual values are essential for its implementation in the routine laboratory. Objectives. We evaluated the fully automated TG analyzer ST Genesia (R) and we aimed to determine usual values with special attention to the pediatric population. Methods. Two ST Genesia (R) reagents were evaluated (Bleedscreen (TM) and Thromboscreen (TM)). Precision, stability, practicability and usual values according to age were established as well as the impact of freezing samples. The comparison between calibrated automated thrombogram (CAT) method and ST Genesia (R) was performed. TG parameters (ETP, peak, velocity, lag time, time to peak) were analyzed on both instruments. All the results were normalized toward a reference plasma. Results. Coefficient of variation associated with the repeatability and reproducibility of the QC norm low, and norm were less than 5% with both Thromboscreen and Bleedscreen reagents. We did not observe any statistical difference between results obtained on fresh or frozen samples. Usual values according to age and sex were established with special attention to the pediatric population. Conclusion. This technique provides a fully automated system, a strict control of temperature and the use of a reference plasma to obtain normalized results. This study is a prerequisite to future use of ST Genesia (R) in clinical application.