Interlaboratory variability of activated protein C resistance using the ETP‐based APC resistance assay

Abstract Background and objective Although the endogenous thrombin potential (ETP)‐based activated protein C (APC) resistance is recommended for the development of steroid contraceptive agents, one of the main limitations of this technique was its lack of standardization, which hampered study‐to‐stu...

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Autores principales:	Laure Morimont, Marie Didembourg, Hélène Haguet, Élise Modaffari, Maxence Tillier, Céline Bouvy, Aurélien Lebreton, Jean‐Michel Dogné, Jonathan Douxfils
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	activated protein C resistance blood coagulation test contraceptive agents laboratories reproducibility of results Diseases of the blood and blood-forming organs RC633-647.5
Acceso en línea:	https://doaj.org/article/6f6c0c8e38c345fcb29951359cce23f9
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spelling	oai:doaj.org-article:6f6c0c8e38c345fcb29951359cce23f92021-11-29T09:35:28ZInterlaboratory variability of activated protein C resistance using the ETP‐based APC resistance assay2475-037910.1002/rth2.12612https://doaj.org/article/6f6c0c8e38c345fcb29951359cce23f92021-10-01T00:00:00Zhttps://doi.org/10.1002/rth2.12612https://doaj.org/toc/2475-0379Abstract Background and objective Although the endogenous thrombin potential (ETP)‐based activated protein C (APC) resistance is recommended for the development of steroid contraceptive agents, one of the main limitations of this technique was its lack of standardization, which hampered study‐to‐study comparison. A validated methodology that meets all the regulatory requirements in terms of analytical performances has been developed recently. To ensure a wide implementation of this test, the assessment of the interlaboratory variability was needed. Method The assay was implemented in three testing laboratories. First, dose‐response curves were performed to locally define APC concentration leading to 90% of ETP inhibition on healthy donors. Intra‐ and inter‐run repeatability were assessed on a reference plasma and three quality controls. To investigate the variability in results among the different testing units, 60 donor samples were analyzed at each site. Results The APC concentration leading to 90% of ETP inhibition was defined at 1.21 µg/ml and 1.14 µg/ml in the two receiving units. Intra‐ and inter‐run repeatability showed standard deviation below 3%. Analyses of the 60 donor samples showed no statistically significant difference. The sensitivity of the test in the different laboratories was maintained and subgroup analyses still reported significant differences depending on hormonal status of donors. Conclusion This study is the first reporting the interlaboratory variability of the ETP‐based APC resistance assay. Data revealed excellent intra‐ and interlaboratory reproducibility. These results support the concept that this blood coagulation test provides an appropriate sensitivity irrespective of the laboratory in which analyses are performed.Laure MorimontMarie DidembourgHélène HaguetÉlise ModaffariMaxence TillierCéline BouvyAurélien LebretonJean‐Michel DognéJonathan DouxfilsWileyarticleactivated protein C resistanceblood coagulation testcontraceptive agentslaboratoriesreproducibility of resultsDiseases of the blood and blood-forming organsRC633-647.5ENResearch and Practice in Thrombosis and Haemostasis, Vol 5, Iss 7, Pp n/a-n/a (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	activated protein C resistance blood coagulation test contraceptive agents laboratories reproducibility of results Diseases of the blood and blood-forming organs RC633-647.5
spellingShingle	activated protein C resistance blood coagulation test contraceptive agents laboratories reproducibility of results Diseases of the blood and blood-forming organs RC633-647.5 Laure Morimont Marie Didembourg Hélène Haguet Élise Modaffari Maxence Tillier Céline Bouvy Aurélien Lebreton Jean‐Michel Dogné Jonathan Douxfils Interlaboratory variability of activated protein C resistance using the ETP‐based APC resistance assay
description	Abstract Background and objective Although the endogenous thrombin potential (ETP)‐based activated protein C (APC) resistance is recommended for the development of steroid contraceptive agents, one of the main limitations of this technique was its lack of standardization, which hampered study‐to‐study comparison. A validated methodology that meets all the regulatory requirements in terms of analytical performances has been developed recently. To ensure a wide implementation of this test, the assessment of the interlaboratory variability was needed. Method The assay was implemented in three testing laboratories. First, dose‐response curves were performed to locally define APC concentration leading to 90% of ETP inhibition on healthy donors. Intra‐ and inter‐run repeatability were assessed on a reference plasma and three quality controls. To investigate the variability in results among the different testing units, 60 donor samples were analyzed at each site. Results The APC concentration leading to 90% of ETP inhibition was defined at 1.21 µg/ml and 1.14 µg/ml in the two receiving units. Intra‐ and inter‐run repeatability showed standard deviation below 3%. Analyses of the 60 donor samples showed no statistically significant difference. The sensitivity of the test in the different laboratories was maintained and subgroup analyses still reported significant differences depending on hormonal status of donors. Conclusion This study is the first reporting the interlaboratory variability of the ETP‐based APC resistance assay. Data revealed excellent intra‐ and interlaboratory reproducibility. These results support the concept that this blood coagulation test provides an appropriate sensitivity irrespective of the laboratory in which analyses are performed.
format	article
author	Laure Morimont Marie Didembourg Hélène Haguet Élise Modaffari Maxence Tillier Céline Bouvy Aurélien Lebreton Jean‐Michel Dogné Jonathan Douxfils
author_facet	Laure Morimont Marie Didembourg Hélène Haguet Élise Modaffari Maxence Tillier Céline Bouvy Aurélien Lebreton Jean‐Michel Dogné Jonathan Douxfils
author_sort	Laure Morimont
title	Interlaboratory variability of activated protein C resistance using the ETP‐based APC resistance assay
title_short	Interlaboratory variability of activated protein C resistance using the ETP‐based APC resistance assay
title_full	Interlaboratory variability of activated protein C resistance using the ETP‐based APC resistance assay
title_fullStr	Interlaboratory variability of activated protein C resistance using the ETP‐based APC resistance assay
title_full_unstemmed	Interlaboratory variability of activated protein C resistance using the ETP‐based APC resistance assay
title_sort	interlaboratory variability of activated protein c resistance using the etp‐based apc resistance assay
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/6f6c0c8e38c345fcb29951359cce23f9
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Interlaboratory variability of activated protein C resistance using the ETP‐based APC resistance assay

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