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

被引：23

作者：

Castaman, G. ^{[1
]}

Tosetto, A. ^{[1
]}

Cappelletti, A. ^{[1
]}

Goodeve, A. ^{[2
]}

Federici, A. B. ^{[3
,4
]}

Batlle, J. ^{[5
]}

Meyer, D. ^{[6
]}

Goudemand, J. ^{[7
]}

Eikenboom, J. C. J. ^{[8
]}

Schneppenheim, R. ^{[9
]}

Budde, U. ^{[10
]}

Ingerslev, J. ^{[11
]}

Lethagen, S. ^{[12
]}

Hill, F. ^{[13
]}

Peake, I. R. ^{[2
]}

Rodeghiero, F. ^{[1
]}

机构：

[1] San Bortolo Hosp, Dept Hematol, I-36100 Vicenza, Italy

[2] Univ Sheffield, Acad Unit Haematol, Sheffield, S Yorkshire, England

[3] Univ Milan, Milan, Italy

[4] Fdn IRCCS Maggiore Policlin Hosp, Hemophilia & Thrombosis Ctr, Mangiagalli Regina Elena, Italy

[5] Hosp Teresa Herrera, Serv Hematol & Hemoterapia, La Coruna, Spain

[6] INSERM, U143, Paris, France

[7] Univ Lille, Lille, France

[8] Leiden Univ, Med Ctr, Dept Thrombosis & Hemostasis, Leiden, Netherlands

[9] Univ Med Ctr Hamburg Eppendorf, Dept Pediat Hematol & Oncol, Hamburg, Germany

[10] Aesculabor Lab, Hamburg, Germany

[11] Univ Hosp Skejby, Ctr Hemophilia & Thrombosis, Aarhus, Denmark

[12] Lund Univ, Dept Coagulat Disorders, Malmo, Sweden

[13] Childrens Hosp Birmingham, Dept Hematol, Birmingham, W Midlands, England

来源：

THROMBOSIS RESEARCH | 2010年 / 126卷 / 03期

关键词：

von Willebrand factor; von Willebrand disease; Inherited bleeding disorders; AUTOMATED-METHOD; PHENOTYPE; GENOTYPE;

D O I：

10.1016/j.thromres.2010.06.013

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background: Accurate measurement of von Willebrand factor (VWF) is a critical requirement for the diagnosis of von Willebrand disease (VWD). Aim of the study: To evaluate the diagnostic efficiency of a rapid quantitative test for the measurement of VWF antigen (VWF:Ag) in type 1 VWD. Patients and methods: 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. Results: The assay linearity range was 10-125 IU/dL for LIA (R(2) = 0.99) and 5-133 IU/dL for ELISA (R(2) = 0.99). The inter-assay CV for low VWF levels (similar to 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). Conclusion: VWF: Ag LIA compared well to standard ELISA in this large population of patients and controls, showing better CV. However the lower detection limit for the VWF: Ag LIA compared to the VWF: Ag ELISA means that the LIA assay is less good at discriminating between type 3 VWD and moderate type 1 VWD. (C) 2010 Elsevier Ltd. All rights reserved.

引用

页码：227 / 231

页数：5

共 21 条

[21] A MONOCLONAL-ANTIBODY (B724) TO VON-WILLEBRAND-FACTOR RECOGNIZING AN EPITOPE WITHIN THE A1 DISULFIDE LOOP (CYS509-CYS695) DISCRIMINATES BETWEEN TYPE 2A AND TYPE 2B VON-WILLEBRAND DISEASE
CHRISTOPHE, O
ROUAULT, C
OBERT, B
PIETU, G
MEYER, D
GIRMA, JP
BRITISH JOURNAL OF HAEMATOLOGY, 1995, 90 (01) : 195 - 203

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