TY - JOUR
T1 - Assessment of the analytical performances and sample stability on ST Genesia system using the STG-DrugScreen application
AU - Douxfils, Jonathan
AU - Morimont, Laure
AU - Bouvy, Céline
AU - de Saint-Hubert, Marie
AU - Devalet, Bérangère
AU - Devroye, Célia
AU - Dincq, Anne-Sophie
AU - Dogné, Jean-Michel
AU - Guldenpfennig, Maïté
AU - Baudar, Justine
AU - Larock, Anne-Sophie
AU - Lessire, Sarah
AU - Mullier, François
N1 - Funding Information:
The study was financed by Diagnostica Stago group. Among the authors, J. Douxfils is chief executive officer and founder of QUALIblood s.a. and reports personal fees from Diagnostica Stago, Roche, Roche Diagnostics, and Daiichi-Sankyo, outside the submitted work. F. Mullier reports institutional fees from Diagnostica Stago, Werfen, Nodia, Sysmex, and Bayer. He also reports speaker fees from Boehringer Ingelheim, Bayer Healthcare, and Bristol-Myers Squibb-Pfizer, all outside the submitted work. The other authors have no conflicts of interest to disclose.
Publisher Copyright:
© 2019 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals, Inc. on behalf of International Society on Thrombosis and Haemostasis
PY - 2019/8
Y1 - 2019/8
N2 - Background: Thrombin generation testing has been used to provide information on the coagulation phenotype of patients. The most used technique is the calibrated automated thrombogram (CAT) but it suffers from a lack of standardization, preventing its implementation in routine. The ST Genesia is a new analyzer designed to assess thrombin generation based on the same principle as the CAT. Unlike the CAT system, the ST Genesia is a benchtop, fully automated analyzer, able to perform the analyses individually and not by batch, with strict control of variables such as temperature and volumes, ensuring, theoretically, maximal reproducibility. Objectives: This study aimed at assessing the performance of the STG-DrugScreen application on the ST Genesia analyzer. We also aimed at exploring stability of plasma samples after freezing and defining a reference normal range. Results: Results demonstrated the excellent interexperiment precision of the ST Genesia and confirmed that the use of a reference plasma helps reducing the inter-experiments variability. Stability revealed that plasma samples are stable for at least 11 months at −70°C or lower, except for those containing low molecular weight heparins which have to be tested within 6 months. Freezing had no effect on the majority of thrombin generation parameters except on time to peak. Conclusions: Our results suggest an easy implementation of thrombin generation with the use of ST Genesia in the routine laboratory. This will facilitate the design of multicentric studies and enable the establishment of reliable and evidence-based thresholds, which may improve the management of patients treated with anticoagulants.
AB - Background: Thrombin generation testing has been used to provide information on the coagulation phenotype of patients. The most used technique is the calibrated automated thrombogram (CAT) but it suffers from a lack of standardization, preventing its implementation in routine. The ST Genesia is a new analyzer designed to assess thrombin generation based on the same principle as the CAT. Unlike the CAT system, the ST Genesia is a benchtop, fully automated analyzer, able to perform the analyses individually and not by batch, with strict control of variables such as temperature and volumes, ensuring, theoretically, maximal reproducibility. Objectives: This study aimed at assessing the performance of the STG-DrugScreen application on the ST Genesia analyzer. We also aimed at exploring stability of plasma samples after freezing and defining a reference normal range. Results: Results demonstrated the excellent interexperiment precision of the ST Genesia and confirmed that the use of a reference plasma helps reducing the inter-experiments variability. Stability revealed that plasma samples are stable for at least 11 months at −70°C or lower, except for those containing low molecular weight heparins which have to be tested within 6 months. Freezing had no effect on the majority of thrombin generation parameters except on time to peak. Conclusions: Our results suggest an easy implementation of thrombin generation with the use of ST Genesia in the routine laboratory. This will facilitate the design of multicentric studies and enable the establishment of reliable and evidence-based thresholds, which may improve the management of patients treated with anticoagulants.
KW - anticoagulants
KW - blood coagulation tests
KW - clinical laboratory techniques
KW - normal range
KW - reproducibility
UR - http://www.scopus.com/inward/record.url?scp=85066495295&partnerID=8YFLogxK
U2 - 10.1111/jth.14470
DO - 10.1111/jth.14470
M3 - Article
C2 - 31063645
SN - 1538-7933
VL - 17
SP - 1273
EP - 1287
JO - Journal of thrombosis and haemostasis : JTH
JF - Journal of thrombosis and haemostasis : JTH
IS - 8
ER -