Pikta Marika, Szanto Timea, Viigimaa Margus, Lejniece Sandra, Balode Dārta, Saks Kadri, Banys Valdas
North Estonia Medical Centre, Department of Laboratory Medicine, Tallinn, Estonia.
Helsinki University Hospital Comprehensive Cancer Centre and University of Helsinki, Coagulation Disorders Unit, Department of Hematology, Helsinki, Finland.
J Med Biochem. 2021 Mar 12;40(2):167-172. doi: 10.5937/jomb0-26008.
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).
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.
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.
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.
准确诊断和分类血管性血友病（VWD）对于优化治疗至关重要。血管性血友病因子多聚体分析（VWF:MM）是表型分类诊断过程的一个组成部分，尤其是在存在差异的病例中。本研究的目的是评估新型Hydragel 11VWF多聚体检测法（H11VW）的性能。
使用内部制备的参考血浆，在健康志愿者血浆中分析H11VW的分析性能特征，如重复性（批内变异、凝胶内泳道间变异）、再现性（批间变异、凝胶间变异）、灵敏度、EQA性能以及两种市售VWF:MM试剂盒（H5VW和H11VW）之间的差异。
H11VW的重复性和再现性结果显示出与先前验证的H5VW相当且可接受的性能。成功参与了EQA。H5VW和H11VW试剂盒在不同多聚体组分方面未检测到统计学上的显著差异：低分子量多聚体p = 0.807；中分子量多聚体p = 0.183；高分子量多聚体p = 0.774。
H11VW表现出可接受的分析性能特征。H11VW试剂盒在单块凝胶上能方便地检测更多样本。H5VW和H11VW试剂盒在日常实践中可互换使用。
