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Assessment of the analytical performances and sample stability on ST Genesia system using the STG-DrugScreen application.
J Thromb Haemost. 2019 08; 17(8):1273-1287.JT

Abstract

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.

Authors+Show Affiliations

Department of Pharmacy, Namur Research Institute for Life Sciences, Namur Thrombosis and Hemostasis Center, University of Namur, Namur, Belgium. Qualiblood s.a., Namur, Belgium.Department of Pharmacy, Namur Research Institute for Life Sciences, Namur Thrombosis and Hemostasis Center, University of Namur, Namur, Belgium.Qualiblood s.a., Namur, Belgium.Department of Geriatric, CHU UCL Namur, Université catholique de Louvain, Yvoir, Belgium.Department of Hematology, Namur Research Institute for Life Sciences, Namur Thrombosis and Hemostasis Center, CHU UCL Namur, Université catholique de Louvain, Yvoir, Belgium.Hematology Laboratory, Namur Research Institute for Life Sciences, Namur Thrombosis and Hemostasis Center, CHU UCL Namur, Université catholique de Louvain, Yvoir, Belgium.Department of Anesthesiology, Namur Research Institute for Life Sciences, Namur Thrombosis and Hemostasis Center, CHU UCL Namur, Université catholique de Louvain, Yvoir, Belgium.Department of Pharmacy, Namur Research Institute for Life Sciences, Namur Thrombosis and Hemostasis Center, University of Namur, Namur, Belgium.Hematology Laboratory, Namur Research Institute for Life Sciences, Namur Thrombosis and Hemostasis Center, CHU UCL Namur, Université catholique de Louvain, Yvoir, Belgium.Hematology Laboratory, Namur Research Institute for Life Sciences, Namur Thrombosis and Hemostasis Center, CHU UCL Namur, Université catholique de Louvain, Yvoir, Belgium.Department of Pharmacy, Namur Research Institute for Life Sciences, Namur Thrombosis and Hemostasis Center, CHU UCL Namur, Université catholique de Louvain, Yvoir, Belgium.Department of Anesthesiology, Namur Research Institute for Life Sciences, Namur Thrombosis and Hemostasis Center, CHU UCL Namur, Université catholique de Louvain, Yvoir, Belgium.Hematology Laboratory, Namur Research Institute for Life Sciences, Namur Thrombosis and Hemostasis Center, CHU UCL Namur, Université catholique de Louvain, Yvoir, Belgium.

Pub Type(s)

Evaluation Study
Journal Article

Language

eng

PubMed ID

31063645

Citation

Douxfils, Jonathan, et al. "Assessment of the Analytical Performances and Sample Stability On ST Genesia System Using the STG-DrugScreen Application." Journal of Thrombosis and Haemostasis : JTH, vol. 17, no. 8, 2019, pp. 1273-1287.
Douxfils J, Morimont L, Bouvy C, et al. Assessment of the analytical performances and sample stability on ST Genesia system using the STG-DrugScreen application. J Thromb Haemost. 2019;17(8):1273-1287.
Douxfils, J., Morimont, L., Bouvy, C., de Saint-Hubert, M., Devalet, B., Devroye, C., Dincq, A. S., Dogné, J. M., Guldenpfennig, M., Baudar, J., Larock, A. S., Lessire, S., & Mullier, F. (2019). Assessment of the analytical performances and sample stability on ST Genesia system using the STG-DrugScreen application. Journal of Thrombosis and Haemostasis : JTH, 17(8), 1273-1287. https://doi.org/10.1111/jth.14470
Douxfils J, et al. Assessment of the Analytical Performances and Sample Stability On ST Genesia System Using the STG-DrugScreen Application. J Thromb Haemost. 2019;17(8):1273-1287. PubMed PMID: 31063645.
* Article titles in AMA citation format should be in sentence-case
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, Y1 - 2019/05/31/ PY - 2019/01/08/received PY - 2019/04/29/accepted PY - 2019/5/8/pubmed PY - 2020/7/15/medline PY - 2019/5/8/entrez KW - anticoagulants KW - blood coagulation tests KW - clinical laboratory techniques KW - normal range KW - reproducibility SP - 1273 EP - 1287 JF - Journal of thrombosis and haemostasis : JTH JO - J. Thromb. Haemost. VL - 17 IS - 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. SN - 1538-7836 UR - https://www.unboundmedicine.com/medline/citation/31063645/Assessment_of_the_analytical_performances_and_sample_stability_on_ST_Genesia_system_using_the_STG_DrugScreen_application_ L2 - https://doi.org/10.1111/jth.14470 DB - PRIME DP - Unbound Medicine ER -