Evaluation of a new semi-automated Hydragel 11 von Willebrand factor multimers assay kit for routine use.

electrophoresis multimers von Willebrand disease von Willebrand factor

Journal

Journal of medical biochemistry
ISSN: 1452-8258
Titre abrégé: J Med Biochem
Pays: Serbia
ID NLM: 101315490

Informations de publication

Date de publication:
12 Mar 2021
Historique:
received: 08 04 2020
accepted: 12 08 2020
entrez: 29 3 2021
pubmed: 30 3 2021
medline: 30 3 2021
Statut: ppublish

Résumé

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. 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). 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 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. 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.

Sections du résumé

BACKGROUND 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 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 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 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 UNASSIGNED
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 METHODS
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 UNASSIGNED
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 UNASSIGNED
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.

Autres résumés

Type: Publisher (srp)
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).

Identifiants

DOI: 10.5937/jomb0-26008 PMID: 33776566 PMC: PMC7982284
pubmed: 33776566
doi: 10.5937/jomb0-26008
pii: jomb-40-2-2102167P
pmc: PMC7982284
doi:

Types de publication

Journal Article

Langues

eng

Pagination

167-172

Informations de copyright

2021 Marika Pikta, Timea Szanto, Margus Viigimaa, Sandra Lejniece, Dārta Balode, Kadri Saks, Valdas Banys, published by CEON/CEES.

Déclaration de conflit d'intérêts

Conflict of Interest: The authors stated that they have no conflicts of interest regarding the publication of this article.

Références

Clin Chem. 2012 Jun;58(6):1010-8
pubmed: 22451621
Methods Mol Biol. 2017;1646:495-511
pubmed: 28804850
Semin Thromb Hemost. 2011 Jul;37(5):440-55
pubmed: 22102186
Haemophilia. 2017 Jul;23(4):e373-e377
pubmed: 28497866
J Clin Lab Anal. 2018 Jul;32(6):e22416
pubmed: 29453814
Int J Lab Hematol. 2018 Jun;40(3):304-311
pubmed: 29427305
Semin Thromb Hemost. 2006 Jul;32(5):485-91
pubmed: 16862521
Res Pract Thromb Haemost. 2018 Aug 12;2(4):790-799
pubmed: 30349898
Int J Lab Hematol. 2018 Oct;40(5):586-591
pubmed: 29920949
Am J Hematol. 2010 Jul;85(7):510-4
pubmed: 20575033
Int J Lab Hematol. 2019 Dec;41(6):762-771
pubmed: 31508897
Int J Lab Hematol. 2015 May;37 Suppl 1:11-7
pubmed: 25976955

Auteurs

Marika Pikta (M)

North Estonia Medical Centre, Department of Laboratory Medicine, Tallinn, Estonia.

Timea Szanto (T)

Helsinki University Hospital Comprehensive Cancer Centre and University of Helsinki, Coagulation Disorders Unit, Department of Hematology, Helsinki, Finland.

Margus Viigimaa (M)

Tallinn University of Technology, Department of Health Technologies, Tallinn, Estonia.

Sandra Lejniece (S)

Riga Stradins University, Riga, Latvia.

Dārta Balode (D)

Riga Stradins University, Riga, Latvia.

Kadri Saks (K)

Tallinn Children`s Hospital, Hematology Department, Tallinn, Estonia.

Valdas Banys (V)

Vilnius University, Faculty of Medicine, Institute of Biomedical Sciences, Department of Physiology, Biochemistry, Microbiology and Laboratory Medicine, Vilnius, Lithuania.

Classifications MeSH