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    Preparation of the first European Working Standard for phenylalanine in bloodspots: EWS-Phe-01

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    Authors
    Elvers LH
    Loeber JG
    Dhondt JL
    Type
    Report
    Language
    en
    
    Metadata
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    Title
    Preparation of the first European Working Standard for phenylalanine in bloodspots: EWS-Phe-01
    Translated Title
    Bereiding van het eerste Europese Standaardpreparaat voor phenylalanine in bloedvlekken: EWS-Phe-01
    Publiekssamenvatting
    Op initiatief van Prof. J.L. Dhondt (Frankrijk) werd op 13 en 14 januari 1996 een werkgroep bijeengeroepen, bestaande uit wetenschappelijke experts en fabrikanten van kits voor de bepaling van phenylalanine. Het doel van de werkgroep was consensus te bereiken over de wijze waarop bloedvlekkalibratoren voor phenylalanine moeten worden gemaakt. Er bleek een duidelijke behoefte te bestaan aan een 'Europees Standaardpreparaat voor phenylalanine in bloedvlekken'. Deze 'European Working Standard for Phenylalanine in bloodspots' (EWS-Phe-01) werd bereid door het RIVM in Bilthoven. In totaal werden 178 bloedvlekkaarten gemaakt met bloedvlekken waarvan de phenylalanineconcentratie werd vastgesteld op 55, 175, 295, 535 en 775 mumol/l. De lineariteit van de verschillende kalibratoren en de homogeniteit van de batch zijn goed. Uit een bewaarexperiment bij verschillende temperaturen, kan op basis van de tot nog toe verkregen resultaten worden afgeleid, dat de batch tenminste 24 weken stabiel is. Additionele data zullen na 1 en 2 jaar worden verkregen. De drie deelnemende fabrikanten van kits voor de bepaling van phenylalanine hebben inmiddels hun kalibratoren geijkt ten opzichte van de EWS-Phe-01. De voorlopige resultaten zien er veelbelovend uit: de onderlinge verschillen in meetuitkomsten zijn veel kleiner geworden.<br>
    On initiative of Prof. J.L. Dhondt (France) a workshop with scientific experts and manufacturers of kits for phenylalanine measurement was arranged in Paris on January 13 and 14, 1996. The aim of the meeting was to reach consensus about the way bloodspot calibrators for phenylalanine should be prepared. An urgent need was noted for a 'Standard preparation for phenylalanine in bloodspots' against which manufacturers of kits for phenylalanine could calibrate their own bloodspot calibrators. This 'European Working Standard for Phenylalanine in bloodspots' (EWS-Phe-01) was prepared by the RIVM (Bilthoven). A total of 178 bloodspot cards were prepared with assigned phenylalanine concentrations of 55, 175, 295, 535 and 775 mumol/l. The linearity of the bloodspot calibrators and the homogeneity of the batch were good. Preliminary results of a storage experiment at different temperatures indicate that the bloodspot calibrators are stable for at least 24 weeks. Additional data will be available after 1 and 2 years. The preliminary results of the recalibration of the calibrators for phenylalanine against EWS-Phe-01 by the three participating manufacturers of kits for phenylalanine are very promising: the differences in measuring levels have been very much decreased.<br>
    Publisher
    Rijksinstituut voor Volksgezondheid en Milieu RIVM
    Sponsors
    IGZ
    URI
    http://hdl.handle.net/10029/258987
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    RIVM official reports

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