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

Research output: Contribution to journalArticle

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 like temperature and volumes, ensuring, theoretically, a 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 inter-experiment 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 below, except for those containing low molecular weight heparins which have to be tested within 6 months. Freezing had no impact 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. This article is protected by copyright. All rights reserved.

Original languageEnglish
JournalJournal of thrombosis and haemostasis : JTH
DOIs
Publication statusE-pub ahead of print - 2019

Fingerprint

Thrombin
Freezing
Reference Values
Low Molecular Weight Heparin
Anticoagulants
Phenotype
Temperature

Cite this

@article{4c8496642ae0421e944283c5862f5704,
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 like temperature and volumes, ensuring, theoretically, a maximal reproducibility.OBJECTIVES: This study aimed at assessing the performance of the STG{\circledR} -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 inter-experiment 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 below, except for those containing low molecular weight heparins which have to be tested within 6 months. Freezing had no impact 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. This article is protected by copyright. All rights reserved.",
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 = "This article is protected by copyright. All rights reserved.",
year = "2019",
doi = "10.1111/jth.14470",
language = "English",
journal = "Journal of thrombosis and haemostasis : JTH",
issn = "1538-7933",
publisher = "Wiley-Blackwell",

}

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 - This article is protected by copyright. All rights reserved.

PY - 2019

Y1 - 2019

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 like temperature and volumes, ensuring, theoretically, a 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 inter-experiment 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 below, except for those containing low molecular weight heparins which have to be tested within 6 months. Freezing had no impact 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. This article is protected by copyright. All rights reserved.

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 like temperature and volumes, ensuring, theoretically, a 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 inter-experiment 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 below, except for those containing low molecular weight heparins which have to be tested within 6 months. Freezing had no impact 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. This article is protected by copyright. All rights reserved.

U2 - 10.1111/jth.14470

DO - 10.1111/jth.14470

M3 - Article

JO - Journal of thrombosis and haemostasis : JTH

JF - Journal of thrombosis and haemostasis : JTH

SN - 1538-7933

ER -