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

Marcus Ljungkvist, Maria Berndtsson, Margareta Holmström, Danijela Mikovic, Ivo Elezovic, Jovan P. Antovic, Eva Zetterberg, Erik Berntorp

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish
Article numbere2017064
JournalMediterranean Journal of Hematology and Infectious Diseases
Issue number1
Publication statusPublished - 2017

Subject classification (UKÄ)

  • Clinical Laboratory Medicine

Free keywords

  • Factor VIII
  • Hemophilia
  • Thrombin generation test


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