Thrombin generation measurement using the ST Genesia Thrombin Generation System in a cohort of healthy adults: Normal values and variability.

Calzavarini, Sara; Brodard, Justine; Quarroz, Claudia; Maire, Livia; Nützi, Raphael; Jankovic, Jovana; Rotondo, Laura C; Giabbani, Evelyne; Fiedler, Georg Martin; Nagler, Michael; Angelillo-Scherrer, Anne (2019). 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, 3(4), pp. 758-768. Wiley 10.1002/rth2.12238

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Institute of Clinical Chemistry
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR)
04 Faculty of Medicine > Service Sector > Institute for Infectious Diseases > General Bacteriology
04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Haematology and Central Haematological Laboratory
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > Unit Childrens Hospital > Forschungsgruppe Hämatologie (Erwachsene)

UniBE Contributor:

Calzavarini, Sara; Brodard, Justine; Fiedler, Georg Martin; Nagler, Michael and Angelillo, Anne

Subjects:

600 Technology > 610 Medicine & health

ISSN:

2475-0379

Publisher:

Wiley

Language:

English

Submitter:

Pierrette Durand Lüthi

Date Deposited:

01 Nov 2019 15:21

Last Modified:

01 Nov 2019 15:21

Publisher DOI:

10.1002/rth2.12238

PubMed ID:

31624796

Uncontrolled Keywords:

blood coagulation factors clinical laboratory tests quality control reference ranges thrombin generation

BORIS DOI:

10.7892/boris.134271

URI:

https://boris.unibe.ch/id/eprint/134271

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