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.
Uvod: Tačna dijagnoza i klasifikacija Fon Vilebrandove bolesti (VVD) su neophodni za optimalni rad. Multimerska analiza Fon Vilebrandovog faktora (VVF:MM) je u fenotipskoj klasifikaciji, posebno u slučajevima neslaganja, sastavni deo dijagnostičkog procesa. Cilj ove studije je bio da proceni performanse novog Hidragel 11VVF multimer testa (H11VV).
Metode: Karakteristike analitičkih performansi, kao što su ponovljivost (varijabilnost unutar testa, u gelu između varijacije traga), obnovljivost (varijabilnost među testovima, između varijacije gela), osetljivost, EQA performanse i razlike između dva komercijalno dostupna VVF:MM seta (H5VV i H11VV) su analizirane na plazmama zdravih dobrovoljaca i interno pripremljenoj referentnoj plazmi.
Rezultati: Rezultati ponovljivosti i obnovljivosti H11VV su pokazali prihvatljive i ekvivalentne performanse sa prethodno verifikovanim H5VV. Učešće u EQA je bilo uspešno. Nije utvrđena statistički značajna razlika između H5VV i H11VV setova za različite frakcije multimera: LMVM p = 0,807; IMVM p = 0,183; HMVM p = 0,774.
Zaključak: H11VV je pokazao prihvatljive karakteristike analitičkih performansi. Korisno je što H11VV komplet nudi veći broj uzoraka na jednom gelu. Kompleti H5VV i H11VV se mogu koristiti naizmenično u svakodnevnoj praksi.
Keywords: electrophoresis; multimers; von Willebrand disease; von Willebrand factor.
2021 Marika Pikta, Timea Szanto, Margus Viigimaa, Sandra Lejniece, Dārta Balode, Kadri Saks, Valdas Banys, published by CEON/CEES.