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

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Ljungkvist , M , Strandberg , K , Berntorp , E , Chaireti , R , Holme , P A , Larsen , O H , Lassila , R , Jouppila , A , Szanto , T & Zetterberg , E 2019 , ' Evaluation of a standardized protocol for thrombin generation using the calibrated automated thrombogram : A Nordic study ' , Haemophilia , vol. 25 , no. 2 , pp. 334-342 . https://doi.org/10.1111/hae.13640

Title: Evaluation of a standardized protocol for thrombin generation using the calibrated automated thrombogram : A Nordic study
Author: Ljungkvist, Marcus; Strandberg, Karin; Berntorp, Erik; Chaireti, Roza; Holme, Pål Andre; Larsen, Ole Halfdan; Lassila, Riitta; Jouppila, Annukka; Szanto, Timea; Zetterberg, Eva
Contributor organization: Clinicum
Hematologian yksikkö
HUSLAB
HUS Comprehensive Cancer Center
Date: 2019-03
Language: eng
Number of pages: 9
Belongs to series: Haemophilia
ISSN: 1351-8216
DOI: https://doi.org/10.1111/hae.13640
URI: http://hdl.handle.net/10138/314537
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 Malmo centre and sent frozen at -20C 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.
Subject: haemophilia
normalization
reference plasma
standardization
test of agreement
thrombin generation assay
RESISTANT RULES
HEMOPHILIA-A
ANTICOAGULANTS
VARIABLES
ASSAY
3121 General medicine, internal medicine and other clinical medicine
Peer reviewed: Yes
Usage restriction: openAccess
Self-archived version: publishedVersion


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