Title: Certification of Cystatin C in the Human Serum Reference Material ERM-DA471/IFCC - Certified Reference Material ERM®-DA471/IFCC
Authors: ZEGERS IngridAUCLAIR GuySCHIMMEL HeinzEMONS HendrikBLIRUP-JENSEN SorenSCHMIDT CamillaLINDSTROM VeronicaGRUBB AndersALTHAUS Harald
Publisher: Publications Office of the European Union
Publication Year: 2010
JRC Publication N°: JRC58953
ISBN: 978-92-79-07562-9
ISSN: 1018-5593
Other Identifiers: EUR 24408 EN
OPOCE LA-NA-24408-EN-C
URI: http://publications.jrc.ec.europa.eu/repository/handle/JRC58953
DOI: 10.2787/26973
Type: EUR - Scientific and Technical Research Reports
Abstract: The production of ERM-DA471/IFCC, certified for the mass concentration of cystatin C, is described. Serum was produced from blood collected in 2 collection centres according to a procedure ensuring that it was obtained from healthy donors, and that the lipid content of the serum was low. The serum was processed, spiked with recombinant cystatin C, and lyophilised. It was verified that the material is homogenous and stable. The material was characterised using a pure protein primary reference preparation (PRP) as calibrant. The PRP was prepared from recombinant cystatin C, and its concentration determined by dry mass determination. The characterisation of ERM-DA471/IFCC was performed by particle enhanced immuno-nephelometry, particle enhanced immuno-turbidimetry and enzyme amplified single radial immuno-diffusion. The certified cystatin C mass concentration in ERM-DA471/IFCC, if reconstituted according to the specified procedure, is 5.48 mg/L, the expanded uncertainty (k = 2) is 0.15 mg/L.
JRC Institute:Institute for Reference Materials and Measurements

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