Title: Characterization of the New Serum Protein Reference Material ERM-DA470k/IFCC: Value Assignment by Immunoassay
Authors: ZEGERS IngridKELLER ThomasSCHREIBER WiebkeSHELDON JoannaALBERTINI RobertoBLIRUP-JENSEN SorenJOHNSON M.TRAPMANN StefanieEMONS HendrikMERLINI GiampaoloSCHIMMEL Heinz
Citation: CLINICAL CHEMISTRY vol. 56 no. 12 p. 1880-1888
Publisher: AMER ASSOC CLINICAL CHEMISTRY
Publication Year: 2010
JRC N°: JRC58476
ISSN: 0009-9147
URI: http://publications.jrc.ec.europa.eu/repository/handle/JRC58476
DOI: 10.1373/clinchem.2010.148809
Type: Articles in Journals
Abstract: BACKGROUND: The availability of a suitable matrix reference material is essential for standardization of the immunoassays used to measure serum proteins. The earlier serum protein reference material ERM-DA470 (previously called CRM470), certified in 1993, has led to a high degree of harmonization of the measurement results. A new serum protein material has now been prepared and its suitability in term of homogeneity and stability has been verified; after characterization, the material has been certified as ERM-DA470k/IFCC. METHODS: We characterized the candidate reference material for 14 proteins by applying a protocol that is considered to be a reference measurement procedure, by use of optimized immunoassays. ERM-DA470 was used as a calibrant. RESULTS: For 12 proteins [alpha2 macroglobulin (A2M), alpha1 acid glycoprotein (orosomucoid, AAG), alpha1 antitrypsin (alpha1-protease inhibitor, AAT), albumin (ALB), complement 3c (C3c), complement 4 (C4), haptoglobin (HPT), IgA, IgG, IgM, transferrin (TRF), and transthyretin (TTR)], the results allowed assignment of certified values in ERM-DA470k/IFCC. For CRP, we observed a bias between the lyophilized and liquid frozen materials, and for CER, the distribution of values was too broad. Therefore, these 2 proteins were not certified in the ERM-DA470k/IFCC. Different value transfer procedures were tested (open and closed procedures) and found to provide equivalent results. CONCLUSIONS: A new serum protein reference material has been produced, and values have been successfully assigned for 12 proteins.
JRC Institute:Institute for Reference Materials and Measurements

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