Analysis of inter-individual variation and reference intervals of thrombin generation test indicators using different technologies
https://doi.org/10.18705/2311-4495-2022-9-5-78-86
Abstract
Background. The thrombin generation test (TGT) as an integral method for analyzing the activation cascade of natural pro- and anticoagulants is of practical importance in assessing the risk of thrombotic conditions and bleeding, however its application is limited by the lack of standardization. Objective. To define reference intervals within the laboratory and assess inter-individual variation in TGT values for different technologies. Design and methods. The study included 20 donors. TGT was performed using two technologies: a calibrated automated thrombogram on a semi-automatic fluorometer (Technology 1) and automatic measurement of GT on a coagulometer (Technology 2). Obtained results were normalized to pooled normal plasma. Results. Thrombogram parameters showed a high CVG (coefficient of interindividual variation): 14–32 % for Technology 1 and 7–36 % for Technology 2. CVG did not change significantly after normalization. Significant differences in ETP (endogenous thrombin potential) were noted. The reference intervals for Technology 1 were: ETR 1478.0–2595.0 nmol/ min and peak thrombin concentration (Peak thr.) 221.6–412.0 nmol. RI for Technology 2: ETP 2451.00–3161.00 nmol/min and Peak thr. 161.60–479.30 nmol. Conclusion. Comparison of the two laboratory TGT technologies revealed high inter-individual variation. Thus, the use of a study in dynamics for each specific individual is likely to be more informative than the use of RI obtained in the general population. Dynamic monitoring of the patient must be performed using one technology.
Keywords
calibrated automated thrombogram,
reference intervals,
thrombin generation,
thrombin generation test
Supporting agencies: The research was carried out at the expense of the grant of the Russian Science Foundation No. 22-25-20132, https://rscf.ru/project/22-25-20132 . We would like to express our gratitude to BioHimMak for the opportunity to perform research on the Ceveron Alpha TGA automatic analyzer.
About the Authors
E. A. Zolotova
Almazov National Medical Research Centre
Russian Federation
Russian Federation
Ekaterina A. Zolotova, MD, PhD student of Department of Laboratory Medicine and Genetics
Akkuratova str., 2, Saint Petersburg, 197341
O. S. Melnichnikova
Almazov National Medical Research Centre
Russian Federation
Russian Federation
Olga S. Melnichnikova, MD, PhD, Senior Researcher, Research Group of Cardio-Oncology, World-Class Research Centre for Personalized Medicine
Saint Petersburg
M. A. Simakova
Almazov National Medical Research Centre
Russian Federation
Russian Federation
Maria A. Simakova, MD, PhD, Senior Researcher, Noncoronary Heart Disease Department, Head of Research Group of Cardio-oncology, Research Centre of Personolized Oncology, World-Class Research Centre for Personalized
Medicine
Saint Petersburg
Y. I. Zhilenkova
Almazov National Medical Research Centre
Russian Federation
Russian Federation
Yulia I. Zhilenkova, MD, PhD, Associate Professor of Department of Laboratory Medicine and Genetics
Saint Petersburg
O. V. Sirotkina
Almazov National Medical Research Centre; Petersburg Nuclear Physics Institute named by B. P. Konstantinov of National Research Centre “Kurchatov Institute”; First Pavlov State Medical University
Russian Federation
Russian Federation
Olga V. Sirotkina, PhD, DSc, Professor of Department of Laboratory Medicine and Genetics, Almazov National Medical Research Centre; senior researcher, Petersburg
Nuclear Physics Institute named by B.P. Konstantinov of National Research Centre «Kurchatov Institute»; senior researcher, Pavlov First Saint-Petersburg State Medical
University
Saint Petersburg
T. V. Vavilova
Almazov National Medical Research Centre
Russian Federation
Russian Federation
Tatiana V. Vavilova, MD, PhD, DSс, Professor, Head of Department of Laboratory Medicine and Genetics
Saint Petersburg
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23.
Review
For citations:
Zolotova E.A., Melnichnikova O.S., Simakova M.A., Zhilenkova Y.I., Sirotkina O.V., Vavilova T.V. Analysis of inter-individual variation and reference intervals of thrombin generation test indicators using different technologies. Translational Medicine. 2022;9(5):78-86. (In Russ.) https://doi.org/10.18705/2311-4495-2022-9-5-78-86
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