Marika Pikta1,2, Galina Zemtsovskaja1,2, Hector Bautista3, Georges Nouadje3, Timea Szanto4, Margus Viigimaa2, Valdas Banys5. 1. North Estonia Medical Centre Laboratory, Tallinn, Estonia. 2. Department of Health Technologies, School of Information Technologies, Tallinn University of Technology, Tallinn, Estonia. 3. Sebia, Research and Developments Department, Parc Technologique Léonard de Vinci, Evry Cedex, France. 4. Coagulation Disorders Unit, HUSLAB Laboratory Services, Department of Hematology and Clinical Chemistry, Helsinki University Hospital, Helsinki, Finland. 5. Faculty of Medicine, Department of Physiology, Biochemistry, Microbiology and Laboratory Medicine, Vilnius University, Vilnius, Lithuania.
Abstract
BACKGROUND: The von Willebrand factor (VWF) multimer test is required to correctly subtype qualitative type 2 von Willebrand disease (VWD). The current VWF multimer assays are difficult, nonstandardized, and time-consuming. The purpose of this study was to evaluate the clinical utility of the commercial VWF multimer kit by Sebia (Lisses, France), an electrophoresis technique yielding same-day results. METHODS: Ten healthy volunteer plasma samples, in-house reference plasma (IRP) and commercial normal plasma (CNP) samples, 10 plasma samples from patients with a known VWD type, 1 hemophilia A plasma sample, and 7 external quality assurance (EQA) samples were analyzed using the commercial VWF multimer kit. Additional coagulation testing included measurements of VWF antigen (VWF:Ag), VWF activity (VWF:Ac), and FVIII activity (FVIII:C). RESULTS: The CNP results revealed a relative loss of the highest molecular weight multimers; therefore, IRP was preferred as the reference sample. The interpretations of 10 patients with a known VWD type could be successfully reproduced and agreed with previous VWF multimer results. In all EQA surveys, the multimer results and final VWD diagnosis agreed with expert opinion. CONCLUSIONS: The VWF multimer assay by Sebia is easy to perform and can be successfully implemented in any clinical laboratory for second-stage evaluation of VWD. The resolution power of multimer distribution is adequate to correctly classify VWD types 1, 2A, 2B, and 3.
BACKGROUND: The von Willebrand factor (VWF) multimer test is required to correctly subtype qualitative type 2 von Willebrand disease (VWD). The current VWF multimer assays are difficult, nonstandardized, and time-consuming. The purpose of this study was to evaluate the clinical utility of the commercial VWF multimer kit by Sebia (Lisses, France), an electrophoresis technique yielding same-day results. METHODS: Ten healthy volunteer plasma samples, in-house reference plasma (IRP) and commercial normal plasma (CNP) samples, 10 plasma samples from patients with a known VWD type, 1 hemophilia A plasma sample, and 7 external quality assurance (EQA) samples were analyzed using the commercial VWF multimer kit. Additional coagulation testing included measurements of VWF antigen (VWF:Ag), VWF activity (VWF:Ac), and FVIII activity (FVIII:C). RESULTS: The CNP results revealed a relative loss of the highest molecular weight multimers; therefore, IRP was preferred as the reference sample. The interpretations of 10 patients with a known VWD type could be successfully reproduced and agreed with previous VWF multimer results. In all EQA surveys, the multimer results and final VWD diagnosis agreed with expert opinion. CONCLUSIONS: The VWF multimer assay by Sebia is easy to perform and can be successfully implemented in any clinical laboratory for second-stage evaluation of VWD. The resolution power of multimer distribution is adequate to correctly classify VWD types 1, 2A, 2B, and 3.
Authors: J E Sadler; U Budde; J C J Eikenboom; E J Favaloro; F G H Hill; L Holmberg; J Ingerslev; C A Lee; D Lillicrap; P M Mannucci; C Mazurier; D Meyer; W L Nichols; M Nishino; I R Peake; F Rodeghiero; R Schneppenheim; Z M Ruggeri; A Srivastava; R R Montgomery; A B Federici Journal: J Thromb Haemost Date: 2006-08-02 Impact factor: 5.824
Authors: Rajiv K Pruthi; Todd M Daniels; John A Heit; Dong Chen; Whyte G Owen; William L Nichols Journal: Thromb Res Date: 2010-12 Impact factor: 3.944