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Monitoring standard and extended half‐life products in hemophilia: Assay discrepancies for factor VIII and IX in pre‐ and postinfusion samples

BACKGROUND: Monitoring hemophilia treatment with extended half‐life products is challenging for coagulation laboratories since factor assays may show substantial differences between results obtained with the one‐stage assay (OSA) and the chromogenic substrate assay (CSA). OBJECTIVES: The aim of this...

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Autores principales: Augustsson, Cecilia, Norström, Eva, Andersson, Nadine Gretenkort, Zetterberg, Eva, Astermark, Jan, Strandberg, Karin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7590307/
https://www.ncbi.nlm.nih.gov/pubmed/33134777
http://dx.doi.org/10.1002/rth2.12421
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author Augustsson, Cecilia
Norström, Eva
Andersson, Nadine Gretenkort
Zetterberg, Eva
Astermark, Jan
Strandberg, Karin
author_facet Augustsson, Cecilia
Norström, Eva
Andersson, Nadine Gretenkort
Zetterberg, Eva
Astermark, Jan
Strandberg, Karin
author_sort Augustsson, Cecilia
collection PubMed
description BACKGROUND: Monitoring hemophilia treatment with extended half‐life products is challenging for coagulation laboratories since factor assays may show substantial differences between results obtained with the one‐stage assay (OSA) and the chromogenic substrate assay (CSA). OBJECTIVES: The aim of this study was to evaluate and compare different factor assays and global coagulation methods. METHODS: Factor VIII (FVIII) and IX (FIX) activities and global assay parameters were analyzed in pre‐ and postinfusion samples (5 patients 2 samples/product/method). RESULTS: Samples containing FVIII products (NovoEight, Elocta, and Nuwiq) gave higher levels when measured with CSA compared to OSA. The correlation was excellent (r (2) ≥ .97) while biases of 42%‐72% of mean (CSA‐OSA) were obtained. With FVIII (OSA) as independent variable, the correlations to kaolin clot time (CT) and thrombin generation assay (TGA) peak were modest (r(2) = .71‐.72 and .64‐.65, respectively), except for Nuwiq for which there was a poor correlation to TGA peak (r (2) = .08). Samples containing Alprolix, a FIX product, gave a smaller difference between activity levels (CSA‐OSA), and the correlation was excellent (r (2) = .96). With FIX (CSA) as independent variable for both Alprolix and Refixia, the correlations to Innovin CT and TGA peaks were weak (r (2) = .33‐.45 and .44‐.76, respectively). CONCLUSIONS: Our data show that factor activity assays differ between methods used and agents. These discrepancies indicate the value of having more than one type of assay available in the coagulation laboratory when monitoring hemophilia treatment with extended half‐life products. Global assays gave complementary information indicated by the modest correlations to factor activities.
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spelling pubmed-75903072020-10-30 Monitoring standard and extended half‐life products in hemophilia: Assay discrepancies for factor VIII and IX in pre‐ and postinfusion samples Augustsson, Cecilia Norström, Eva Andersson, Nadine Gretenkort Zetterberg, Eva Astermark, Jan Strandberg, Karin Res Pract Thromb Haemost Original Articles ‐ Hemostasis BACKGROUND: Monitoring hemophilia treatment with extended half‐life products is challenging for coagulation laboratories since factor assays may show substantial differences between results obtained with the one‐stage assay (OSA) and the chromogenic substrate assay (CSA). OBJECTIVES: The aim of this study was to evaluate and compare different factor assays and global coagulation methods. METHODS: Factor VIII (FVIII) and IX (FIX) activities and global assay parameters were analyzed in pre‐ and postinfusion samples (5 patients 2 samples/product/method). RESULTS: Samples containing FVIII products (NovoEight, Elocta, and Nuwiq) gave higher levels when measured with CSA compared to OSA. The correlation was excellent (r (2) ≥ .97) while biases of 42%‐72% of mean (CSA‐OSA) were obtained. With FVIII (OSA) as independent variable, the correlations to kaolin clot time (CT) and thrombin generation assay (TGA) peak were modest (r(2) = .71‐.72 and .64‐.65, respectively), except for Nuwiq for which there was a poor correlation to TGA peak (r (2) = .08). Samples containing Alprolix, a FIX product, gave a smaller difference between activity levels (CSA‐OSA), and the correlation was excellent (r (2) = .96). With FIX (CSA) as independent variable for both Alprolix and Refixia, the correlations to Innovin CT and TGA peaks were weak (r (2) = .33‐.45 and .44‐.76, respectively). CONCLUSIONS: Our data show that factor activity assays differ between methods used and agents. These discrepancies indicate the value of having more than one type of assay available in the coagulation laboratory when monitoring hemophilia treatment with extended half‐life products. Global assays gave complementary information indicated by the modest correlations to factor activities. John Wiley and Sons Inc. 2020-08-11 /pmc/articles/PMC7590307/ /pubmed/33134777 http://dx.doi.org/10.1002/rth2.12421 Text en © 2020 The Authors. Research and Practice in Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Original Articles ‐ Hemostasis
Augustsson, Cecilia
Norström, Eva
Andersson, Nadine Gretenkort
Zetterberg, Eva
Astermark, Jan
Strandberg, Karin
Monitoring standard and extended half‐life products in hemophilia: Assay discrepancies for factor VIII and IX in pre‐ and postinfusion samples
title Monitoring standard and extended half‐life products in hemophilia: Assay discrepancies for factor VIII and IX in pre‐ and postinfusion samples
title_full Monitoring standard and extended half‐life products in hemophilia: Assay discrepancies for factor VIII and IX in pre‐ and postinfusion samples
title_fullStr Monitoring standard and extended half‐life products in hemophilia: Assay discrepancies for factor VIII and IX in pre‐ and postinfusion samples
title_full_unstemmed Monitoring standard and extended half‐life products in hemophilia: Assay discrepancies for factor VIII and IX in pre‐ and postinfusion samples
title_short Monitoring standard and extended half‐life products in hemophilia: Assay discrepancies for factor VIII and IX in pre‐ and postinfusion samples
title_sort monitoring standard and extended half‐life products in hemophilia: assay discrepancies for factor viii and ix in pre‐ and postinfusion samples
topic Original Articles ‐ Hemostasis
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7590307/
https://www.ncbi.nlm.nih.gov/pubmed/33134777
http://dx.doi.org/10.1002/rth2.12421
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