ArticleResearch and practice in thrombosis and haemostasis2021
Interlaboratory variability of activated protein C resistance using the ETP-based APC resistance assay.
Article in Research and practice in thrombosis and haemostasis, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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Who cites it
4 citing papers in PubMed, 9 citations in OpenAlex.
- Chapter 3. Impact of estrogens on hemostasis.Frontiers in endocrinology · 2025Review
- Evaluation of Activated Protein C Resistance Using Thrombin Generation Test.Methods in molecular biology (Clifton, N.J.) · 2023Article
- 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 · 2022Article
- Interlaboratory variability of activated protein C resistance using the ETP-based APC resistance assay.Research and practice in thrombosis and haemostasis · 2021Article
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Authors and funding
9 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveAlthough 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.
methodThe 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.
resultsThe 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.
conclusionThis 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.
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