Characterization of the new serum protein reference material ERM-DA470k/IFCC: Value assignment by immunoassay

Ingrid Zegers, Thomas Keller, Wiebke Schreiber, Joanna Sheldon, Riccardo Albertini, Søren Blirup-Jensen, Myron Johnson, Stefanie Trapmann, Hendrik Emons, Giampaolo Merlini, Heinz Schimmel

Research output: Contribution to journalArticlepeer-review

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 [α2 macroglobulin (A2M), α1 acid glycoprotein (orosomucoid, AAG), α1 antitrypsin (α1-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.

Original languageEnglish
Pages (from-to)1880-1888
Number of pages9
JournalClinical Chemistry
Volume56
Issue number12
DOIs
Publication statusPublished - Dec 2010

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Biochemistry, medical

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