Title: The Certification of the Mass Concentration of C-Reactive Protein in Human Serum - Certified Reference Material ERM®-DA474/IFCC
Publisher: Publications Office of the European Union
Publication Year: 2011
JRC N°: JRC66287
ISBN: 978-92-79-21040-2 (print), 978-92-79-21041-9 (pdf)
ISSN: 1018-5593 (print), 1831-9424 (online)
Other Identifiers: EUR 24922 EN
OPOCE LA-NA-24-922-EN-C (print), LA-NA-24-922-EN-N (online)
URI: http://publications.jrc.ec.europa.eu/repository/handle/JRC66287
DOI: 10.2787/49424
Type: EUR - Scientific and Technical Research Reports
Abstract: This report describes the production of ERM-DA474/IFCC, a human serum material certified for C-reactive protein. The material has been produced following ISO Guide 34:2009. Between unit-heterogeity has been quantified and stability during dispatch ans storage have been assessed in accordance with ISO Guide 35:2006. The material was characterised by an intercomparison among laboratories of demonstrated competence. Technically invalid results were removed but no outlier was eliminated on statistical grounds only. Uncertainties of the certified values were calculated in compliance with the Guide to the Expression of Uncertainty in Measurement (GUM) and include uncertainties related to possible heterogeneity and instability and to characterisation. The material is intended for the calibration of immunoassays. As any reference material, it can also be used for control charts or validation studies. The CRM is available in glass vials containing 1 mL of human serum closed under argon atmosphere. The minimum amount of sample to be used is 20 µL. The CRM has been accepted as European Reference Material (ERM®) after peer evaluation by the partners of the European Reference Materials consortium.
JRC Directorate:Health, Consumers and Reference Materials

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