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Correlation to FVIII : C in two thrombin generation tests: TGA-CAT and INNOVANCE ETP

Ljungkvist, Marcus LU ; Berndtsson, Maria; Holmström, Margareta; Mikovic, Danijela; Elezovic, Ivo; Antovic, Jovan P.; Zetterberg, Eva LU and Berntorp, Erik LU (2017) In Mediterranean Journal of Hematology and Infectious Diseases 9(1).
Abstract

Introduction: Several thrombin-generation tests are available, but few have been directly compared. Our primary aim was to investigate the correlation of two thrombin generation tests, thrombin generation assay-calibrated automated thrombogram (TGA-CAT) and INNOVANCE ETP, to factor VIII levels (FVIII:C) in a group of patients with hemophilia A. The secondary aim was to investigate inter-laboratory variation for the TGA-CAT method. Methods: Blood samples were taken from 45 patients with mild, moderate and severe hemophilia A. The TGA-CAT method was performed at both centers while the INNOVANCE ETP was only performed at the Stockholm center. Correlation between parameters was evaluated using Spearman's rank correlation test. For... (More)

Introduction: Several thrombin-generation tests are available, but few have been directly compared. Our primary aim was to investigate the correlation of two thrombin generation tests, thrombin generation assay-calibrated automated thrombogram (TGA-CAT) and INNOVANCE ETP, to factor VIII levels (FVIII:C) in a group of patients with hemophilia A. The secondary aim was to investigate inter-laboratory variation for the TGA-CAT method. Methods: Blood samples were taken from 45 patients with mild, moderate and severe hemophilia A. The TGA-CAT method was performed at both centers while the INNOVANCE ETP was only performed at the Stockholm center. Correlation between parameters was evaluated using Spearman's rank correlation test. For determination of the TGA-CAT inter-laboratory variability, Bland-Altman plots were used. Results: The correlation for the INNOVANCE ETP and TGA-CAT methods with FVIII:C in persons with hemophilia (PWH) was r=0.701 and r=0.734 respectively. The correlation between the two methods was r=0.546. When dividing the study material into disease severity groups (mild, moderate and severe) based on FVIII levels, both methods fail to discriminate between them. The variability of the TGA-CAT results performed at the two centers was reduced after normalization; before normalization, 29% of values showed less than ±10% difference while after normalization the number increased to 41%. Conclusions: Both methods correlate in an equal manner to FVIII:C in PWH but show a poor correlation with each other. The level of agreement for the TGA-CAT method was poor though slightly improved after normalization of data. Further improvement of standardization of these methods is warranted.

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author
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Contribution to journal
publication status
published
subject
keywords
Factor VIII, Hemophilia, Thrombin generation test
in
Mediterranean Journal of Hematology and Infectious Diseases
volume
9
issue
1
publisher
Universita Cattolica del Sacro Cuore
external identifiers
  • scopus:85032578498
  • wos:000417276100002
ISSN
2035-3006
DOI
10.4084/mjhid.2017.064
language
English
LU publication?
yes
id
805eaf58-a372-4047-8fb6-41f5041967d4
date added to LUP
2017-11-15 13:02:37
date last changed
2018-02-07 15:04:13
@article{805eaf58-a372-4047-8fb6-41f5041967d4,
  abstract     = {<p>Introduction: Several thrombin-generation tests are available, but few have been directly compared. Our primary aim was to investigate the correlation of two thrombin generation tests, thrombin generation assay-calibrated automated thrombogram (TGA-CAT) and INNOVANCE ETP, to factor VIII levels (FVIII:C) in a group of patients with hemophilia A. The secondary aim was to investigate inter-laboratory variation for the TGA-CAT method. Methods: Blood samples were taken from 45 patients with mild, moderate and severe hemophilia A. The TGA-CAT method was performed at both centers while the INNOVANCE ETP was only performed at the Stockholm center. Correlation between parameters was evaluated using Spearman's rank correlation test. For determination of the TGA-CAT inter-laboratory variability, Bland-Altman plots were used. Results: The correlation for the INNOVANCE ETP and TGA-CAT methods with FVIII:C in persons with hemophilia (PWH) was r=0.701 and r=0.734 respectively. The correlation between the two methods was r=0.546. When dividing the study material into disease severity groups (mild, moderate and severe) based on FVIII levels, both methods fail to discriminate between them. The variability of the TGA-CAT results performed at the two centers was reduced after normalization; before normalization, 29% of values showed less than ±10% difference while after normalization the number increased to 41%. Conclusions: Both methods correlate in an equal manner to FVIII:C in PWH but show a poor correlation with each other. The level of agreement for the TGA-CAT method was poor though slightly improved after normalization of data. Further improvement of standardization of these methods is warranted.</p>},
  articleno    = {e2017064},
  author       = {Ljungkvist, Marcus and Berndtsson, Maria and Holmström, Margareta and Mikovic, Danijela and Elezovic, Ivo and Antovic, Jovan P. and Zetterberg, Eva and Berntorp, Erik},
  issn         = {2035-3006},
  keyword      = {Factor VIII,Hemophilia,Thrombin generation test},
  language     = {eng},
  number       = {1},
  publisher    = {Universita Cattolica del Sacro Cuore},
  series       = {Mediterranean Journal of Hematology and Infectious Diseases},
  title        = {Correlation to FVIII : C in two thrombin generation tests: TGA-CAT and INNOVANCE ETP},
  url          = {http://dx.doi.org/10.4084/mjhid.2017.064},
  volume       = {9},
  year         = {2017},
}