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

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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 originaleAnglais
Numéro d'articlee12684
Pages (de - à)e12684
journalResearch and Practice in Thrombosis and Haemostasis
Numéro de publication3
Les DOIs
Etat de la publicationPublié - mars 2022

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