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Validation of a rap...
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
- Article/chapterEnglish2010
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LIBRIS-ID:oai:lup.lub.lu.se:3fc96eae-581d-4993-b2dc-ad9f8f73d70f
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https://lup.lub.lu.se/record/1672100URI
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https://doi.org/10.1016/j.thromres.2010.06.013DOI
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Language:English
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Summary in:English
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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.
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Tosetto, A.
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Cappelletti, A.
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Goodeve, A.
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Federici, A. B.
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Batlle, J.
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Meyer, D.
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Goudemand, J.
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Eikenboom, J. C. J.
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Schneppenheim, R.
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Budde, U.
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Ingerslev, J.
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Lethagen, StefanLund University,Lunds universitet,Institutionen för kliniska vetenskaper, Malmö,Medicinska fakulteten,Department of Clinical Sciences, Malmö,Faculty of Medicine(Swepub:lu)medf-sle
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Hill, F.
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Peake, I. R.
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Rodeghiero, F.
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Institutionen för kliniska vetenskaper, MalmöMedicinska fakulteten
(creator_code:org_t)
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In:Thrombosis Research: Elsevier BV126:3, s. 227-2311879-24720049-3848
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Castaman, G.
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Tosetto, A.
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Cappelletti, A.
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Goodeve, A.
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Federici, A. B.
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Batlle, J.
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Meyer, D.
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Goudemand, J.
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Eikenboom, J. C. ...
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Schneppenheim, R ...
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Budde, U.
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Ingerslev, J.
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Lethagen, Stefan
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Hill, F.
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Peake, I. R.
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Rodeghiero, F.
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Thrombosis Resea ...
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Lund University