Analytical performance of the endogenous thrombin potential–based activated protein C resistance assay on the automated ST Genesia system
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 vi...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-03-01
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| Series: | Research and Practice in Thrombosis and Haemostasis |
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| Online Access: | https://doi.org/10.1002/rth2.12684 |
| _version_ | 1827832032188694528 |
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| author | Laure Morimont Charline Leclercq Marie Didembourg Émilie De Gottal Audrey Carlo Ulysse Gaspard Jean‐Michel Dogné Jonathan Douxfils |
| author_facet | Laure Morimont Charline Leclercq Marie Didembourg Émilie De Gottal Audrey Carlo Ulysse Gaspard Jean‐Michel Dogné Jonathan Douxfils |
| author_sort | Laure Morimont |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T05:04:00Z |
| format | Article |
| id | doaj.art-a293cee760b1421995598bd52a43c3d8 |
| institution | Directory Open Access Journal |
| issn | 2475-0379 |
| language | English |
| last_indexed | 2024-03-12T05:04:00Z |
| publishDate | 2022-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Research and Practice in Thrombosis and Haemostasis |
| spelling | doaj.art-a293cee760b1421995598bd52a43c3d82023-09-03T09:03:30ZengElsevierResearch and Practice in Thrombosis and Haemostasis2475-03792022-03-0163n/an/a10.1002/rth2.12684Analytical performance of the endogenous thrombin potential–based activated protein C resistance assay on the automated ST Genesia systemLaure Morimont0Charline Leclercq1Marie Didembourg2Émilie De Gottal3Audrey Carlo4Ulysse Gaspard5Jean‐Michel Dogné6Jonathan Douxfils7Qualiblood sa Namur BelgiumDepartment of Gynecology Centre Hospitalier Régional de Huy Liège BelgiumDepartment of Pharmacy Faculty of Medicine Namur Research Institute for Life Sciences (NARILIS) Namur Thrombosis and Hemostasis Center (NTHC) University of Namur Namur BelgiumDepartment of Gynecology Centre Hospitalier Régional de Huy Liège BelgiumDiagnostica Stago Asnières‐sur‐Seine FranceDepartment of Obstetrics and Gynecology University of Liège Liège BelgiumDepartment of Pharmacy Faculty of Medicine Namur Research Institute for Life Sciences (NARILIS) Namur Thrombosis and Hemostasis Center (NTHC) University of Namur Namur BelgiumQualiblood sa Namur BelgiumAbstract 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.https://doi.org/10.1002/rth2.12684activated protein C resistancecombined oral contraceptivesreproducibility of resultsthrombinvenous thromboembolism |
| spellingShingle | Laure Morimont Charline Leclercq Marie Didembourg Émilie De Gottal Audrey Carlo Ulysse Gaspard Jean‐Michel Dogné Jonathan Douxfils 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 activated protein C resistance combined oral contraceptives reproducibility of results thrombin venous thromboembolism |
| title | Analytical performance of the endogenous thrombin potential–based activated protein C resistance assay on the automated ST Genesia system |
| title_full | Analytical performance of the endogenous thrombin potential–based activated protein C resistance assay on the automated ST Genesia system |
| title_fullStr | Analytical performance of the endogenous thrombin potential–based activated protein C resistance assay on the automated ST Genesia system |
| title_full_unstemmed | Analytical performance of the endogenous thrombin potential–based activated protein C resistance assay on the automated ST Genesia system |
| title_short | Analytical performance of the endogenous thrombin potential–based activated protein C resistance assay on the automated ST Genesia system |
| title_sort | analytical performance of the endogenous thrombin potential based activated protein c resistance assay on the automated st genesia system |
| topic | activated protein C resistance combined oral contraceptives reproducibility of results thrombin venous thromboembolism |
| url | https://doi.org/10.1002/rth2.12684 |
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