ArticleResearch and practice in thrombosis and haemostasis2022
Analytical performance of the endogenous thrombin potential-based activated protein C resistance assay on the automated ST Genesia system.
Article in Research and practice in thrombosis and haemostasis, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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5 citing papers in PubMed, 10 citations in OpenAlex.
- Cost-effective screening strategy to prevent venous thromboembolism in combined oral contraceptive users.Frontiers in endocrinology · 2025Article
- Chapter 3. Impact of estrogens on hemostasis.Frontiers in endocrinology · 2025Review
- Thrombomodulin is a stronger indicator of combined oral contraceptives-induced activated protein C pathway resistance in the thrombin generation test than activated protein C.Frontiers in cardiovascular medicine · 2024Article
- 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
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Authors and funding
8 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
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.
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