PB1157 - Comparison of (semi-)automated thrombin generation platforms for specific coagulopathies with bleeding diathesis.

Tuesday, June 27, 2023

18:30 – 19:30 ET

Room: Exhibition

Presenting Author(s)

Sanna R. Rijpma, PhD

Clinical chemist
Department of Laboratory Medicine, Laboratory of Hematology, Radboud university medical center, Nijmegen, the Netherlands
Radboud, Gelderland, Netherlands

Co-Author(s)

Rv

René van Oerle

Chief Operating Officer
Coagulation Profile, Maastricht, The Netherlands
Maastricht, Limburg, Netherlands
KV

Kitty Verbeek-Knobbe

Laboratory technician
Mrs.
Nijmegen, Gelderland, Netherlands
DH

Dave Hellenbrand

Senior Researcher
Department of Central Diagnostic Laboratory, MUMC +, Maastricht, The Netherlands
Maastricht, Limburg, Netherlands
EV

Evelien Verwoerd

Laboratory technician
Ms
Nijmegen, Gelderland, Netherlands
SS

Saskia E.M. Schols

Internist-hematologist
Department of Hematology, Radboud university medical center, Nijmegen, The Netherlands. Hemophilia Treatment Center Nijmegen – Eindhoven – Maastricht, The Netherlands
Nijmegen, Gelderland, Netherlands
FH

Floor C.J.I. Heubel-Moenen

Hematologist
Department Hematology, MUMC+, Maastricht, the Netherlands
Maastricht, Limburg, Netherlands
An Stroobants, PhD

Clinical Chemist
Dept. of Laboratory Medicine, Radboud University Medical Center Nijmegen, the Netherlands
Nijmegen, Gelderland, Netherlands
DM

Daniëlle Meijer

Clinical chemist
Department of Laboratory Medicine, Laboratory of Hematology, Radboud university medical center, Nijmegen, the Netherlands
Nijmegen, Gelderland, Netherlands
Yvonne Henskens, MSc PhD

Professor in Clinical Chemistry, Clinical chemist
Central Diagnostic Laboratory at Maastricht University Medical Centre+
Maastricht, Limburg, Netherlands

Background: The generation of thrombin is a pivotal step in the formation of fibrin and represents net coagulation resulting from pro- and anticoagulant factors. Measurement of thrombin generation has been hampered by a lack of standardization of (pre-analytical) test parameters. Recently, a number of (semi-) automated assays applying specific reagents have become available for clinical application.

Aims: The aim of the study is to define test characteristics of (semi-)automated thrombin generation assays and evaluate performance of the different reagents and platforms for specific coagulopathies with bleeding diathesis.

Methods: (Pooled) samples of healthy controls and patients with specific factor deficiencies (Factor II, V, VII, VIII, IX, X, XI and VWF) were collected through a standardized pre-analytical protocol. Thrombin generation was measured at Calibrated Automated Thrombogram (CAT, Stago), ST Genesia (Stago) and Ceveron S100 (Technoclone) platforms using all available standardized reagents. Results were normalized using within-run results of one pooled normal plasma for all measurements.

Results: Test specifications, coefficients of variation (CV) and variation of normal individuals were determined for all reagents on the tested platforms. The application of reagents with the lowest tissue factor concentration and analysis of the Area Under the Curve (AUC) parameter resulted in the most pronounced decrease of thrombin generation on all platforms for pooled samples of specific coagulopathies with bleeding diatheses. A significant (Friedman’s testing) decrease in thrombin generation was detected for the AUC as determined by CAT compared to Ceveron S100 in this sample set (Figure 1A). Moreover, for specific factor deficiencies, discrepancies in thrombin generation results were observed between the platforms (Figure 1B).

Conclusion(s): The application of reagents with low tissue factor concentrations on all (semi-)automated platforms results in a most pronounced decrease of thrombin generation for coagulopathies with bleeding diathesis. Platform-dependent specifications in reagent composition may lead to differences in thrombin generation results for specific coagulopathies.