Abstract Number: PB1290
Meeting: ISTH 2021 Congress
Background: Regulatory bodies recommend assessing the endogenous thrombin potential (ETP)-based activated protein C (APC) resistance assay during the development of combined oral contraceptives (COC) in women. In 2019, this assay was validated on the Calibrated Automated Thrombogram (CAT) device using commercially available reagent to ensure batch-to-batch traceability, and reproducibility of the method over time. However, in view of its screening potential, its implementation in clinical routine is essential.
Aims: This study aimed at implementing the ETP-based APC resistance assay on the automated ST Genesia system (Stago, France), using reagent STG-ThromboScreen -TM (TS -TM) (Stago, France) with exogenous APC added (Stago, France).
Methods: Healthy pooled plasma (HPP) constituted of 20 healthy individuals (10 males and 10 women not using COC, not carrier of FV Leiden or G20210A mutation) was used to define APC concentration leading to 90% of inhibition of the ETP. Dose-response curves were performed on two different batches of TS -TM. The intra- (N=5) and inter-run (N=10) variability were assessed on three samples: STG-RefPlasma TS, STG-QualiTest Norm TS and STG-QualiTest High TS. STG-QualiTest Low TS was not assessed as thrombin generation was completely inhibited in presence of APC. Twenty samples from healthy individuals were analyzed to define reference ranges.
Results: The APC concentration [IC95%] leading to 90% of inhibition of the ETP, on both batches of TS -TM was defined at 652 mU/mL [534-805 mU/mL]. Intra- and inter-run variability showed standard deviations (SD) values below 2.5% and 4.0 % respectively, regardless of the tested samples. The mean inhibition percentage [±SD] of the 20 healthy subjects was 90.6% [±7.4%]
Conclusions: The ETP-based APC resistance assay has been successfully transferred onto the ST Genesia, a routine clinical device for evaluating thrombin generation. Confirmation of promising results on thrombogenicity identification for all COC users is still needed before this test can become commercially available.
To cite this abstract in AMA style:Morimont L, Didembourg M, Dogné J-, Carlo A, Douxfils J. Transferability of the ETP-based APC Resistance Assay on the ST Genesia System [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/transferability-of-the-etp-based-apc-resistance-assay-on-the-st-genesia-system/. Accessed August 16, 2022.
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