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.
ZEGERS Ingrid;
AUCLAIR Guy;
SCHIMMEL Heinz;
EMONS Hendrik;
BLIRUP-JENSEN Soren;
SCHMIDT Camilla;
LINDSTROM Veronica;
GRUBB Anders;
ALTHAUS Harald;
2010-06-14
Publications Office of the European Union
JRC58953
978-92-79-07562-9,
1018-5593,
EUR 24408 EN,
OP LA-NA-24408-EN-C,
https://publications.jrc.ec.europa.eu/repository/handle/JRC58953,
10.2787/26973,
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