Marika Pikta1, Timea Szanto2, Margus Viigimaa3, Sandra Lejniece4, Dārta Balode4, Kadri Saks5, Valdas Banys6. 1. North Estonia Medical Centre, Department of Laboratory Medicine, Tallinn, Estonia. 2. Helsinki University Hospital Comprehensive Cancer Centre and University of Helsinki, Coagulation Disorders Unit, Department of Hematology, Helsinki, Finland. 3. Tallinn University of Technology, Department of Health Technologies, Tallinn, Estonia. 4. Riga Stradins University, Riga, Latvia. 5. Tallinn Children`s Hospital, Hematology Department, Tallinn, Estonia. 6. Vilnius University, Faculty of Medicine, Institute of Biomedical Sciences, Department of Physiology, Biochemistry, Microbiology and Laboratory Medicine, Vilnius, Lithuania.
Abstract
BACKGROUND: Accurate diagnosis and classification of von Willebrand disease (VWD) are essential for optimal management. The von Willebrand factor multimers analysis (VWF:MM) is an integral part of the diagnostic process in the phenotypic classification, especially in discrepant cases. The aim of this study was to evaluate the performance of a new Hydragel 11VWF multimer assay (H11VW). METHODS: Analytical performance characteristics such as repeatability (intra-assay variability, in gel between track variation), reproducibility (inter-assay variability, between gel variation), sensitivity, EQA performance and differences between two commercially available VWF:MM kits (H5VW and H11VW) were analysed in healthy volunteers' plasmas using in-house prepared reference plasma. RESULTS: Repeatability and reproducibility results of H11VW demonstrated acceptable and equivalent performance with previously verified H5VW. Participation in EQA was successful. No statistically significant difference was detected between H5VW and H11VW kits for different fractions of multimers: LMWM p=0.807; IMWM p=0.183; HMWM p=0.774. CONCLUSIONS: H11VW demonstrated acceptable analytical performance characteristics. H11VW kit conveniently offers a more significant number of samples on a single gel. H5VW and H11VW kits can be used in daily practice interchangeably. 2021 Marika Pikta, Timea Szanto, Margus Viigimaa, Sandra Lejniece, Dārta Balode, Kadri Saks, Valdas Banys, published by CEON/CEES.
BACKGROUND: Accurate diagnosis and classification of von Willebrand disease (VWD) are essential for optimal management. The von Willebrand factor multimers analysis (VWF:MM) is an integral part of the diagnostic process in the phenotypic classification, especially in discrepant cases. The aim of this study was to evaluate the performance of a new Hydragel 11VWF multimer assay (H11VW). METHODS: Analytical performance characteristics such as repeatability (intra-assay variability, in gel between track variation), reproducibility (inter-assay variability, between gel variation), sensitivity, EQA performance and differences between two commercially available VWF:MM kits (H5VW and H11VW) were analysed in healthy volunteers' plasmas using in-house prepared reference plasma. RESULTS: Repeatability and reproducibility results of H11VW demonstrated acceptable and equivalent performance with previously verified H5VW. Participation in EQA was successful. No statistically significant difference was detected between H5VW and H11VW kits for different fractions of multimers: LMWM p=0.807; IMWM p=0.183; HMWM p=0.774. CONCLUSIONS: H11VW demonstrated acceptable analytical performance characteristics. H11VW kit conveniently offers a more significant number of samples on a single gel. H5VW and H11VW kits can be used in daily practice interchangeably. 2021 Marika Pikta, Timea Szanto, Margus Viigimaa, Sandra Lejniece, Dārta Balode, Kadri Saks, Valdas Banys, published by CEON/CEES.
Entities:
Keywords:
electrophoresis; multimers; von Willebrand disease; von Willebrand factor
Authors: Annette E Bowyer; Karen J Goodfellow; Holger Seidel; Philipp Westhofen; Francesca Stufano; Anne Goodeve; Stephen Kitchen; Michael Makris Journal: Res Pract Thromb Haemost Date: 2018-08-12