| Practical and cost-effective measurement of B-domain deleted and full-length recombinant FVIII in the routine haemostasis laboratory. | |
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MedLine Citation:
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PMID: 23374099 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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The assessment of recombinant FVIII (rFVIII) activity (FVIII:C) in plasma of patients is dependent on the assay. Notably, a calibration with a product-specific laboratory standard is recommended when measuring Refacto-AF(R) activity in plasma with a one-stage assay. The objective of this study was to facilitate the measurement of rFVIII, taking into account the recent demonstration that a calibration curve does not have to be included in each run. FVIII:C was measured in patients' samples after infusion of different types of rFVIII with a one-stage and a chromogenic assay calibrated either with pooled normal plasma or a product-specific laboratory standard. Results obtained with the one-stage coagulation assay were compared with these provided by a chromogenic assay. We confirmed that a calibration curve can be used for a prolonged period of time without loss of precision and accuracy. In such conditions, a stable relation between the calibration curves generated with a product-specific laboratory standard and plasma can be established. In patients' plasma, Refacto-AF levels measured with a one-stage FVIII assay calibrated with plasma or a product-specific laboratory standard diverged from -58% to -17% and from -25% to +18%, respectively, from the activity determined with a chromogenic substrate assay. By comparison, FVIII:C levels of full-length rFVIII measured with the one-stage assay calibrated with plasma were 6-49% lower than with the chromogenic assay. In a monocentric setting, the long-term stability of the calibration curves allows the implementation of a practical and cost-effective approach to determine rFVIII:C levels. |
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Authors:
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M Cauchie; J Toelen; K Peerlinck; M Jacquemin |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2013-2-4 |
Journal Detail:
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Title: Haemophilia : the official journal of the World Federation of Hemophilia Volume: - ISSN: 1365-2516 ISO Abbreviation: Haemophilia Publication Date: 2013 Feb |
Date Detail:
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Created Date: 2013-2-4 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9442916 Medline TA: Haemophilia Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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© 2013 Blackwell Publishing Ltd. |
Affiliation:
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Center for Molecular and Vascular Biology, University of Leuven, Leuven, Belgium. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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