Harmonisation of factor VIII:C assay results: study within the framework of the Dutch project ‘Calibration 2000’

Summary In a Dutch project for harmonisation of factor VIII coagulant activity (FVIII:C) assays, the commutability of potential calibrators for FVIII:C was assessed by means of a ‘twin‐study design’, which is in essence a multi‐centre, split‐patient sample, between‐field‐methods protocol. Commutability was defined as the degree to which a material yielded the same numerical relationships between results of measurements by a given set of measurement procedures as those between the expectations of the relationships for the same procedures applied to those types of material for which the procedur... Mehr ...

Verfasser: Van Den Besselaar, Anton M. H. P.
Haas, Fred J. L. M.
Kuypers, Aldy W. H. M.
Dokumenttyp: Artikel
Erscheinungsdatum: 2005
Reihe/Periodikum: British Journal of Haematology ; volume 132, issue 1, page 75-79 ; ISSN 0007-1048 1365-2141
Verlag/Hrsg.: Wiley
Schlagwörter: Hematology
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-27080059
Datenquelle: BASE; Originalkatalog
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Link(s) : http://dx.doi.org/10.1111/j.1365-2141.2005.05829.x

Summary In a Dutch project for harmonisation of factor VIII coagulant activity (FVIII:C) assays, the commutability of potential calibrators for FVIII:C was assessed by means of a ‘twin‐study design’, which is in essence a multi‐centre, split‐patient sample, between‐field‐methods protocol. Commutability was defined as the degree to which a material yielded the same numerical relationships between results of measurements by a given set of measurement procedures as those between the expectations of the relationships for the same procedures applied to those types of material for which the procedures were intended. The study consisted of the simultaneous analysis of fresh frozen patient plasmas and three potential calibrators for FVIII:C by 16 Dutch laboratories forming eight couples. The state‐of‐the‐art intra‐laboratory standard deviation was used to assess the commutability of the potential calibrators. One potential calibrator was used to harmonise FVIII:C assay results in a Dutch field study. The inter‐laboratory coefficient of variation of two test samples could be reduced significantly, but no significant effect was observed with three other test samples. We recommend that at least three different sample dilutions be used in each FVIII:C assay, in agreement with previous recommendations.