Validation of a rapid test (VWF-LIA) for the quantitative determination of von Willebrand factor antigen in type 1 von Willebrand disease diagnosis within the European multicenter study MCMDM-1VWD

Thrombosis Research
G CastamanF Rodeghiero

Abstract

Accurate measurement of von Willebrand factor (VWF) is a critical requirement for the diagnosis of von Willebrand disease (VWD). To evaluate the diagnostic efficiency of a rapid quantitative test for the measurement of VWF antigen (VWF:Ag) in type 1 VWD. VWF:Ag was measured with an ELISA in a robotic instrument, as a reference method, and with a fully automated latex-immunoassay (LIA) on an ACL 9000 analyser in 1,716 subjects enrolled within the Molecular and Clinical Markers for Diagnosis and Management of Type 1 von Willebrand Disease (MCMDM-1VWD) Study. Among these subjects, 1,049 were healthy controls, 281 healthy family members and 386 affected members from 127 European families with type 1 VWD. The assay linearity range was 10-125 IU/dL for LIA (R2=0.99) and 5-133 IU/dL for ELISA (R2=0.99). The inter-assay CV for low VWF levels (approximately 30 IU/dL) was 2% for the LIA test and 8.7 % for ELISA. The sensitivity for detection of type 1 VWD affected members was 86% and the specificity 91% for LIA, 87% and 90% for ELISA. A receiver-operator (ROC) analysis disclosed only a marginal difference between the two tests, LIA having a slightly greater area under the curve (0.94 vs. 0.93, p=0.03). VWF:Ag LIA compared well to standar...Continue Reading

References

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Citations

Dec 30, 2015·Journal of Thrombosis and Haemostasis : JTH·A de Jong, J Eikenboom
Mar 21, 2013·Haemophilia : the Official Journal of the World Federation of Hemophilia·W G GroenK Fischer
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Feb 27, 2016·Blood·Jonathan C RobertsUNKNOWN Zimmerman Program Investigators
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Dec 7, 2016·Clinical and Applied Thrombosis/hemostasis : Official Journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis·Arjun Swami, Varinder Kaur
Dec 21, 2018·Platelets·Nina Haagenrud SchultzEva-Marie Jacobsen
May 6, 2019·Journal of Thrombosis and Haemostasis : JTH·Barbara LunghiMassimo Morfini
Oct 1, 2020·Journal of Thrombosis and Haemostasis : JTH·Eugenia BiguzziFlora Peyvandi
Apr 2, 2021·Journal of Blood Medicine·Giancarlo Castaman, Silvia Linari

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