Analytical performance of the endogenous thrombin potential–based activated protein C resistance assay on the automated ST Genesia system

Laure Morimont; Charline Leclercq; Marie Didembourg; Émilie De Gottal; Audrey Carlo; Ulysse Gaspard; Jean-Michel Dogné; Jonathan Douxfils

doi:10.1002/rth2.12684

Analytical performance of the endogenous thrombin potential–based activated protein C resistance assay on the automated ST Genesia system

Laure Morimont, Charline Leclercq, Marie Didembourg, Émilie De Gottal, Audrey Carlo, Ulysse Gaspard, Jean-Michel Dogné, Jonathan Douxfils

Résultats de recherche: Contribution à un journal/une revue › Article › Revue par des pairs

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Résumé

Abstract Background The evaluation of activated protein C (APC) resistance based on the endogenous thrombin potential (ETP) is recommended during the development of steroid contraceptives in women. In 2019, this assay was validated on the calibrated automated thrombogram (CAT) device. However, in view of its screening potential, its automation is essential. Objectives To transfer the ETP-based APC resistance assay on the ST Genesia system using reagent STG-ThromboScreen with exogenous APC added. Method Dose-response curves were performed to define APC concentration leading to 90 and interrun reproducibility was assessed. The normal range was defined on the basis of 56 samples from healthy individuals. The sensitivity was assessed on 40 samples from women using combined oral contraceptives (COCs). A method comparison with the validated ETP-based APC resistance on the CAT system was performed. Results were expressed in normalized APC sensitivity ratio (nAPCsr). Results The APC concentration leading to 9052 mU/mL. Intra- and interrun reproducibility showed standard deviation

langue originale	Anglais
Numéro d'article	e12684
Pages (de - à)	e12684
journal	Research and Practice in Thrombosis and Haemostasis
Volume	6
Numéro de publication	3
Les DOIs	https://doi.org/10.1002/rth2.12684
Etat de la publication	Publié - mars 2022

SDG des Nations Unies

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10.1002/rth2.12684

9771-2022-MorimontVersion finale publiée, 1,14 MB

https://onlinelibrary.wiley.com/doi/abs/10.1002/rth2.12684

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Clinical Pharmacology Research Group
Douxfils, J., Dogne, J., Musuamba Tshinanu, F., MASEREEL, B., Wieers, G., Haguet, H., RONVAUX, L., Donis, N., Morimont, L., Evrard, J., Siriez, R., Gillot, C., FAVRESSE, J., BOUVY, C., Djokoto, H., Didembourg, M., David, C., Melchionda, S., Maloteau, V., Boucher, A., Devel, P., Modaffari, E., Vandeputte, M., De Messemaeker, A., Decarpentrie, J., Vassart, J. & De Groote, A.
1/04/22 → …
Projet: Axe de recherche
The HIC Project : Evaluation of hormone-induced coagulopathy
Dogne, J., Douxfils, J., Morimont, L., Didembourg, M. & Evrard, J.
1/09/19 → …
Projet: Recherche

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Morimont, L., Leclercq, C., Didembourg, M., De Gottal, É., Carlo, A., Gaspard, U., Dogné, J-M., & Douxfils, J. (2022). Analytical performance of the endogenous thrombin potential–based activated protein C resistance assay on the automated ST Genesia system. Research and Practice in Thrombosis and Haemostasis, 6(3), e12684. [e12684]. https://doi.org/10.1002/rth2.12684

@article{5e0a7b88a1fc4256aae47d323745c6b8,

title = "Analytical performance of the endogenous thrombin potential–based activated protein C resistance assay on the automated ST Genesia system",

abstract = "Background: The evaluation of activated protein C (APC) resistance based on the endogenous thrombin potential (ETP) is recommended during the development of steroid contraceptives in women. In 2019, this assay was validated on the calibrated automated thrombogram (CAT) device. However, in view of its screening potential, its automation is essential. Objectives: To transfer the ETP-based APC resistance assay on the ST Genesia system using reagent STG-ThromboScreen with exogenous APC added. Method: Dose-response curves were performed to define APC concentration leading to 90% ETP inhibition on healthy donors. Intra- and interrun reproducibility was assessed. The normal range was defined on the basis of 56 samples from healthy individuals. The sensitivity was assessed on 40 samples from women using combined oral contraceptives (COCs). A method comparison with the validated ETP-based APC resistance on the CAT system was performed. Results were expressed in normalized APC sensitivity ratio (nAPCsr). Results: The APC concentration leading to 90% ETP inhibition was 652 mU/mL. Intra- and interrun reproducibility showed standard deviation <4%. The nAPCsr normal range stood between 0.00 and 2.20. Analyses of 40 samples from women using COCs confirmed the good sensitivity of the assay. Compared to the CAT system, nAPCsr values were slightly higher on the automated system. Conclusion: This study is the first reporting the analytical performances of the ETP-based APC resistance assay on an automated platform. Results support the concept that this test, when incorporated into clinical routine, could become a promising regulatory and clinical tool to document on the thrombogenicity of female hormonal therapies.",

keywords = "activated protein C resistance, combined oral contraceptives, reproducibility of results, thrombin, venous thromboembolism",

author = "Laure Morimont and Charline Leclercq and Marie Didembourg and {De Gottal}, {\'E}milie and Audrey Carlo and Ulysse Gaspard and Jean-Michel Dogn{\'e} and Jonathan Douxfils",

note = "Funding Information: This study was financed by QUALIblood sa, by the Walloon Region in Belgium (government source) ‐ convention 8031, and by Diagnostica Stago. Publisher Copyright: {\textcopyright} 2022 The Authors. Research and Practice in Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis (ISTH).",

year = "2022",

month = mar,

doi = "10.1002/rth2.12684",

language = "English",

volume = "6",

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issn = "2475-0379",

publisher = "Wiley-Blackwell Publishing Ltd",

number = "3",

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Morimont, L, Leclercq, C, Didembourg, M, De Gottal, É, Carlo, A, Gaspard, U, Dogné, J-M & Douxfils, J 2022, 'Analytical performance of the endogenous thrombin potential–based activated protein C resistance assay on the automated ST Genesia system', Research and Practice in Thrombosis and Haemostasis, VOL. 6, Numéro 3, e12684, p. e12684. https://doi.org/10.1002/rth2.12684

Analytical performance of the endogenous thrombin potential–based activated protein C resistance assay on the automated ST Genesia system. / Morimont, Laure; Leclercq, Charline; Didembourg, Marie et al.

Dans: Research and Practice in Thrombosis and Haemostasis, Vol 6, Numéro 3, e12684, 03.2022, p. e12684.

Résultats de recherche: Contribution à un journal/une revue › Article › Revue par des pairs

TY - JOUR

T1 - Analytical performance of the endogenous thrombin potential–based activated protein C resistance assay on the automated ST Genesia system

AU - Morimont, Laure

AU - Leclercq, Charline

AU - Didembourg, Marie

AU - De Gottal, Émilie

AU - Carlo, Audrey

AU - Gaspard, Ulysse

AU - Dogné, Jean-Michel

AU - Douxfils, Jonathan

N1 - Funding Information: This study was financed by QUALIblood sa, by the Walloon Region in Belgium (government source) ‐ convention 8031, and by Diagnostica Stago. Publisher Copyright: © 2022 The Authors. Research and Practice in Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis (ISTH).

PY - 2022/3

Y1 - 2022/3

N2 - Background: The evaluation of activated protein C (APC) resistance based on the endogenous thrombin potential (ETP) is recommended during the development of steroid contraceptives in women. In 2019, this assay was validated on the calibrated automated thrombogram (CAT) device. However, in view of its screening potential, its automation is essential. Objectives: To transfer the ETP-based APC resistance assay on the ST Genesia system using reagent STG-ThromboScreen with exogenous APC added. Method: Dose-response curves were performed to define APC concentration leading to 90% ETP inhibition on healthy donors. Intra- and interrun reproducibility was assessed. The normal range was defined on the basis of 56 samples from healthy individuals. The sensitivity was assessed on 40 samples from women using combined oral contraceptives (COCs). A method comparison with the validated ETP-based APC resistance on the CAT system was performed. Results were expressed in normalized APC sensitivity ratio (nAPCsr). Results: The APC concentration leading to 90% ETP inhibition was 652 mU/mL. Intra- and interrun reproducibility showed standard deviation <4%. The nAPCsr normal range stood between 0.00 and 2.20. Analyses of 40 samples from women using COCs confirmed the good sensitivity of the assay. Compared to the CAT system, nAPCsr values were slightly higher on the automated system. Conclusion: This study is the first reporting the analytical performances of the ETP-based APC resistance assay on an automated platform. Results support the concept that this test, when incorporated into clinical routine, could become a promising regulatory and clinical tool to document on the thrombogenicity of female hormonal therapies.

AB - Background: The evaluation of activated protein C (APC) resistance based on the endogenous thrombin potential (ETP) is recommended during the development of steroid contraceptives in women. In 2019, this assay was validated on the calibrated automated thrombogram (CAT) device. However, in view of its screening potential, its automation is essential. Objectives: To transfer the ETP-based APC resistance assay on the ST Genesia system using reagent STG-ThromboScreen with exogenous APC added. Method: Dose-response curves were performed to define APC concentration leading to 90% ETP inhibition on healthy donors. Intra- and interrun reproducibility was assessed. The normal range was defined on the basis of 56 samples from healthy individuals. The sensitivity was assessed on 40 samples from women using combined oral contraceptives (COCs). A method comparison with the validated ETP-based APC resistance on the CAT system was performed. Results were expressed in normalized APC sensitivity ratio (nAPCsr). Results: The APC concentration leading to 90% ETP inhibition was 652 mU/mL. Intra- and interrun reproducibility showed standard deviation <4%. The nAPCsr normal range stood between 0.00 and 2.20. Analyses of 40 samples from women using COCs confirmed the good sensitivity of the assay. Compared to the CAT system, nAPCsr values were slightly higher on the automated system. Conclusion: This study is the first reporting the analytical performances of the ETP-based APC resistance assay on an automated platform. Results support the concept that this test, when incorporated into clinical routine, could become a promising regulatory and clinical tool to document on the thrombogenicity of female hormonal therapies.

KW - activated protein C resistance

KW - combined oral contraceptives

KW - reproducibility of results

KW - thrombin

KW - venous thromboembolism

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DO - 10.1002/rth2.12684

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Analytical performance of the endogenous thrombin potential–based activated protein C resistance assay on the automated ST Genesia system

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Clinical Pharmacology Research Group

The HIC Project : Evaluation of hormone-induced coagulopathy

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