Assessment of the analytical performances and sample stability on ST Genesia system using the STG-DrugScreen application

Jonathan Douxfils, Laure Morimont, Céline Bouvy, Marie de Saint-Hubert, Bérangère Devalet, Célia Devroye, Anne-Sophie Dincq, Jean-Michel Dogné, Maïté Guldenpfennig, Justine Baudar, Anne-Sophie Larock, Sarah Lessire, François Mullier

Résultats de recherche: Contribution à un journal/une revueArticle

Résumé

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.

langue originaleAnglais
Pages (de - à)1273-1287
Nombre de pages15
journalJournal of thrombosis and haemostasis : JTH
Volume17
Numéro de publication8
Date de mise en ligne précoce2019
Les DOIs
étatPublié - 1 janv. 2019

Empreinte digitale

Thrombin
Freezing
Reference Values
Low Molecular Weight Heparin
Anticoagulants
Phenotype
Temperature

Citer ceci

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title = "Assessment of the analytical performances and sample stability on ST Genesia system using the STG-DrugScreen application",
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.",
keywords = "anticoagulants, blood coagulation tests, clinical laboratory techniques, normal range, reproducibility",
author = "Jonathan Douxfils and Laure Morimont and C{\'e}line Bouvy and {de Saint-Hubert}, Marie and B{\'e}rang{\`e}re Devalet and C{\'e}lia Devroye and Anne-Sophie Dincq and Jean-Michel Dogn{\'e} and Ma{\"i}t{\'e} Guldenpfennig and Justine Baudar and Anne-Sophie Larock and Sarah Lessire and Fran{\cc}ois Mullier",
note = "{\circledC} 2019 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals, Inc. on behalf of International Society on Thrombosis and Haemostasis.",
year = "2019",
month = "1",
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Assessment of the analytical performances and sample stability on ST Genesia system using the STG-DrugScreen application. / Douxfils, Jonathan; Morimont, Laure; Bouvy, Céline; de Saint-Hubert, Marie; Devalet, Bérangère; Devroye, Célia; Dincq, Anne-Sophie; Dogné, Jean-Michel; Guldenpfennig, Maïté; Baudar, Justine; Larock, Anne-Sophie; Lessire, Sarah; Mullier, François.

Dans: Journal of thrombosis and haemostasis : JTH, Vol 17, Numéro 8, 01.01.2019, p. 1273-1287.

Résultats de recherche: Contribution à un journal/une revueArticle

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 - © 2019 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals, Inc. on behalf of International Society on Thrombosis and Haemostasis.

PY - 2019/1/1

Y1 - 2019/1/1

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

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U2 - 10.1111/jth.14470

DO - 10.1111/jth.14470

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VL - 17

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EP - 1287

JO - Journal of thrombosis and haemostasis : JTH

JF - Journal of thrombosis and haemostasis : JTH

SN - 1538-7933

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