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Haemophilia. 2019 Mar;25(2):334-342. doi: 10.1111/hae.13640. Epub 2019 Feb 4.

Evaluation of a standardized protocol for thrombin generation using the calibrated automated thrombogram: A Nordic study.

Author information

1
Department of Translational Medicine & Centre for Thrombosis and Haemostasis, Lund University, Malmö, Sweden.
2
Clinical Chemistry, University and Regional Laboratories Region Scania, Malmö, Sweden.
3
Department of Hematology, Karolinska University Hospital, Stockholm, Sweden.
4
Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.
5
Department of Haematology, Oslo University Hospital and Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
6
Centre for Haemophilia and Thrombosis, Aarhus University Hospital, Skejby, Denmark.
7
Unit of Coagulation Disorders, Department of Hematology, Helsinki University Central Hospital, Helsinki, Finland.
8
Helsinki University Central Hospital Research Institute, Helsinki, Finland.
9
Unit of Coagulation Disorders, HUSLAB Laboratory Services, Department of Clinical Chemistry, Helsinki University Hospital, Helsinki, Finland.

Abstract

INTRODUCTION:

The thrombin generation assay-calibrated automated thrombogram (TGA-CAT) method is used to measure the overall coagulation capacity in plasma. However, the method is still considered to be a research tool, mainly because of its' lack of standardization.

AIM:

Our study aimed to further raise the standardization level for the TGA-CAT method by evaluating a detailed standardization protocol and three reference plasmas' (RP)s ability to normalize results.

METHODS:

Six Nordic centres participated in the study, and with input from all centres a detailed laboratory standardization protocol based on the TGA-CAT manual of the manufacturer was established. Three types of plasma, hypo-,normal and hypercoagulable plasma were assessed. Three commercial lyophilized RPs were used for normalization of data. All samples were aliquoted at the Malmö centre and sent frozen at -20˚C to participating centres.

RESULTS:

Before normalization, all results under all testing conditions showed inter-laboratory coefficient of variability of 10% or lower except for endogenous thrombin potential (12%) and peak (14%) in hypo-plasma with 1 pmol/L tissue factor as starting agent. Successful normalization, improving variability in results, was obtained with two of the three evaluated RPs (HemosIL RP and Affinity RP).

CONCLUSION:

With our standardization concept, we were able to produce TGA-CAT results as robust as standard coagulation assays used in the routine laboratories. Normalization with HemosIL RP may be considered in populations with low or unknown coagulability, while when analysing plasma samples from populations where hypercoagulability is known or suspected, normalization with Affinity RP may be preferred.

KEYWORDS:

haemophilia; normalization; reference plasma; standardization; test of agreement; thrombin generation assay

PMID:
30715788
DOI:
10.1111/hae.13640

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