Validation of factor VIII activity for monitoring standard and extended half-life products and correlation to thrombin generation assays

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@article{9266c9b7ea89478f86ab018b313adccc,
title = "Validation of factor VIII activity for monitoring standard and extended half-life products and correlation to thrombin generation assays",
abstract = "Introduction: Monitoring replacement therapy with standard and extended half-life (EHL) products is challenging, since one-stage assay (OSA) and chromogenic substrate assay (CSA) results may differ significantly. Recent recommendations include local validation of each new product with recovery within 20–30%, depending on activity level. Aim: To validate factor VIII (FVIII) activity for monitoring products in clinical use on Atellica Coag and to correlate it with thrombin generation. Methods: Plasma samples spiked with Advate{\textregistered}, Elocta{\textregistered}, Adynovi{\textregistered}, Nuwiq{\textregistered}, NovoEight{\textregistered} and Afstyla{\textregistered} (0.05, 0.20, 0.50 and 0.80 IU/ml) were analysed using Atellica Coag 360 with CSA-1 (Coatest SP) and CSA-2 (FVIII chromogenic), and OSA (Actin FS). Thrombin generation was performed using two thrombin generation assays (TGA-1 (Thrombinoscope) and TGA-2 (Technothrombin). Results: All products at levels above 0.05 IU/ml, except Adynovi, showed acceptable recovery using CSA-1, whereas measurements using CSA-2 gave more results outside the target level. All products, except Afstyla, showed acceptable recovery using OSA. Correlation between CSA-1 and OSA was excellent (r2=1.0) with biases of 6–3​2%, depending on FVIII product. A clear dose-response was seen for all thrombin generation parameters and products using both methods, except at low levels for lag time using TGA-1. With CSA-1 as an independent variable, the correlations to thrombin peak (measured with TGA-2) were good (r2 =.8–.9). Conclusion: Our data revealed good correlation and acceptable bias between CSA and OSA using our sets of reagents, methods and analyser in spiked samples. Thrombin generation gave good correlation to CSA-1 factor activity and is a possible complement to factor activity assays.",
keywords = "blood coagulation tests, coagulants, drug monitoring, factor VIII, haemophilia A",
author = "Cecilia Augustsson and Eva Norstr{\"o}m and Vivian Lind and Myriam Martin and Jan Astermark and Karin Strandberg",
year = "2021",
month = may,
day = "1",
doi = "10.1111/hae.14317",
language = "English",
volume = "27",
pages = "494--500",
journal = "Haemophilia",
issn = "1351-8216",
publisher = "Federation of European Neuroscience Societies and Blackwell Publishing Ltd",
number = "3",

}