Thrombin generation measurement using the ST Genesia Thrombin Generation System in a cohort of healthy adults: Normal values and variability
Abstract Background Thrombin generation (TG) assays evaluate the balance between pro‐ and anticoagulant forces, to better assess bleeding and thrombotic risks. Although TG readouts obtained with the calibrated automated TG have been investigated in multiple clinical conditions, TG still needs standa...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2019-10-01
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| Series: | Research and Practice in Thrombosis and Haemostasis |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/rth2.12238 |
| _version_ | 1797706426134560768 |
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| author | Sara Calzavarini Justine Brodard Claudia Quarroz Livia Maire Raphael Nützi Jovana Jankovic Laura C. Rotondo Evelyne Giabbani Georg Martin Fiedler Michael Nagler Anne Angelillo‐Scherrer |
| author_facet | Sara Calzavarini Justine Brodard Claudia Quarroz Livia Maire Raphael Nützi Jovana Jankovic Laura C. Rotondo Evelyne Giabbani Georg Martin Fiedler Michael Nagler Anne Angelillo‐Scherrer |
| author_sort | Sara Calzavarini |
| collection | DOAJ |
| description | Abstract Background Thrombin generation (TG) assays evaluate the balance between pro‐ and anticoagulant forces, to better assess bleeding and thrombotic risks. Although TG readouts obtained with the calibrated automated TG have been investigated in multiple clinical conditions, TG still needs standardization and clinical validation. The automated TG instrument ST Genesia® (STG, Stago, Asnières‐sur‐Seine, France) provides a normalization of TG parameters based on a reference plasma aiming to reduce the interlaboratory variability and the variability between different measurement runs. Objectives To evaluate STG in a group of healthy adults. Methods Reference intervals in healthy adults and variability of the new standardized reagents for bleeding (BleedScreen) and thrombophilic (ThromboScreen) conditions were determined using STG. Results TG was measured in platelet‐free plasma (PFP) samples of 123 healthy adults. Reference intervals were determined for TG parameters. Intra‐ and interassay coefficients of variation were calculated on quality controls and PFP samples from healthy adults. Oral contraception (OC) possibly influenced TG parameters, resulting in a higher median and a broader reference interval for peak height and endogenous thrombin potential (ETP) in women aged 20 to 49 years than in all other sex and age categories. Therefore, we propose the following reference interval categories: men, women aged <50 years not using OC, women aged <50 years using OC, and women aged ≥50 years. Normalization was effective to reduce the interassay variability of quality controls for ETP (BleedScreen assay), and peak height and ETP (ThromboScreen assay without thrombomodulin), but had little impact on PFP sample variability. Conclusion STG appears suitable for accurate measurement of TG in healthy adults. |
| first_indexed | 2024-03-12T05:52:03Z |
| format | Article |
| id | doaj.art-f9368806954c4edfae54d4f0b8a5a90d |
| institution | Directory Open Access Journal |
| issn | 2475-0379 |
| language | English |
| last_indexed | 2024-03-12T05:52:03Z |
| publishDate | 2019-10-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Research and Practice in Thrombosis and Haemostasis |
| spelling | doaj.art-f9368806954c4edfae54d4f0b8a5a90d2023-09-03T05:07:32ZengElsevierResearch and Practice in Thrombosis and Haemostasis2475-03792019-10-013475876810.1002/rth2.12238Thrombin generation measurement using the ST Genesia Thrombin Generation System in a cohort of healthy adults: Normal values and variabilitySara Calzavarini0Justine Brodard1Claudia Quarroz2Livia Maire3Raphael Nützi4Jovana Jankovic5Laura C. Rotondo6Evelyne Giabbani7Georg Martin Fiedler8Michael Nagler9Anne Angelillo‐Scherrer10Department of Hematology and Central Hematology Laboratory, Inselspital Bern University HospitalUniversity of Bern Bern SwitzerlandDepartment of Hematology and Central Hematology Laboratory, Inselspital Bern University HospitalUniversity of Bern Bern SwitzerlandDepartment of Hematology and Central Hematology Laboratory, Inselspital Bern University HospitalUniversity of Bern Bern SwitzerlandDepartment of Hematology and Central Hematology Laboratory, Inselspital Bern University HospitalUniversity of Bern Bern SwitzerlandDepartment of Hematology and Central Hematology Laboratory, Inselspital Bern University HospitalUniversity of Bern Bern SwitzerlandDepartment of Hematology and Central Hematology Laboratory, Inselspital Bern University HospitalUniversity of Bern Bern SwitzerlandDepartment of Hematology and Central Hematology Laboratory, Inselspital Bern University HospitalUniversity of Bern Bern SwitzerlandDepartment of Hematology and Central Hematology Laboratory, Inselspital Bern University HospitalUniversity of Bern Bern SwitzerlandInstitute of Clinical Chemistry InselspitalBern University HospitalUniversity of Bern Bern SwitzerlandDepartment of Hematology and Central Hematology Laboratory, Inselspital Bern University HospitalUniversity of Bern Bern SwitzerlandDepartment of Hematology and Central Hematology Laboratory, Inselspital Bern University HospitalUniversity of Bern Bern SwitzerlandAbstract Background Thrombin generation (TG) assays evaluate the balance between pro‐ and anticoagulant forces, to better assess bleeding and thrombotic risks. Although TG readouts obtained with the calibrated automated TG have been investigated in multiple clinical conditions, TG still needs standardization and clinical validation. The automated TG instrument ST Genesia® (STG, Stago, Asnières‐sur‐Seine, France) provides a normalization of TG parameters based on a reference plasma aiming to reduce the interlaboratory variability and the variability between different measurement runs. Objectives To evaluate STG in a group of healthy adults. Methods Reference intervals in healthy adults and variability of the new standardized reagents for bleeding (BleedScreen) and thrombophilic (ThromboScreen) conditions were determined using STG. Results TG was measured in platelet‐free plasma (PFP) samples of 123 healthy adults. Reference intervals were determined for TG parameters. Intra‐ and interassay coefficients of variation were calculated on quality controls and PFP samples from healthy adults. Oral contraception (OC) possibly influenced TG parameters, resulting in a higher median and a broader reference interval for peak height and endogenous thrombin potential (ETP) in women aged 20 to 49 years than in all other sex and age categories. Therefore, we propose the following reference interval categories: men, women aged <50 years not using OC, women aged <50 years using OC, and women aged ≥50 years. Normalization was effective to reduce the interassay variability of quality controls for ETP (BleedScreen assay), and peak height and ETP (ThromboScreen assay without thrombomodulin), but had little impact on PFP sample variability. Conclusion STG appears suitable for accurate measurement of TG in healthy adults.https://doi.org/10.1002/rth2.12238blood coagulation factorsclinical laboratory testsquality controlreference rangesthrombin generation |
| spellingShingle | Sara Calzavarini Justine Brodard Claudia Quarroz Livia Maire Raphael Nützi Jovana Jankovic Laura C. Rotondo Evelyne Giabbani Georg Martin Fiedler Michael Nagler Anne Angelillo‐Scherrer Thrombin generation measurement using the ST Genesia Thrombin Generation System in a cohort of healthy adults: Normal values and variability Research and Practice in Thrombosis and Haemostasis blood coagulation factors clinical laboratory tests quality control reference ranges thrombin generation |
| title | Thrombin generation measurement using the ST Genesia Thrombin Generation System in a cohort of healthy adults: Normal values and variability |
| title_full | Thrombin generation measurement using the ST Genesia Thrombin Generation System in a cohort of healthy adults: Normal values and variability |
| title_fullStr | Thrombin generation measurement using the ST Genesia Thrombin Generation System in a cohort of healthy adults: Normal values and variability |
| title_full_unstemmed | Thrombin generation measurement using the ST Genesia Thrombin Generation System in a cohort of healthy adults: Normal values and variability |
| title_short | Thrombin generation measurement using the ST Genesia Thrombin Generation System in a cohort of healthy adults: Normal values and variability |
| title_sort | thrombin generation measurement using the st genesia thrombin generation system in a cohort of healthy adults normal values and variability |
| topic | blood coagulation factors clinical laboratory tests quality control reference ranges thrombin generation |
| url | https://doi.org/10.1002/rth2.12238 |
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