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Characterization of the New Serum Protein Reference Material ERM-DA470k/IFCC: Value Assignment by Immunoassay

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Author

  • Ingrid Zegers
  • Thomas Keller
  • Wiebke Schreiber
  • Joanna Sheldon
  • Riccardo Albertini
  • Soren Blirup
  • Myron Johnson
  • Stefanie Trapmann
  • Hendrik Emons
  • Giampaolo Merlini
  • Heinz Schimmel
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Summary, in English

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 [alpha(2) macroglobulin (A2M), alpha(1) acid glycoprotein (orosomucoid, AAG), alpha(1) antitrypsin (alpha(1)-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. (C) 2010 American Association for Clinical Chemistry

Publishing year

2010

Language

English

Pages

1880-1888

Publication/Series

Clinical Chemistry

Volume

56

Issue

12

Document type

Journal article

Publisher

American Association for Clinical Chemistry

Topic

  • Biochemistry and Molecular Biology

Status

Published

ISBN/ISSN/Other

  • ISSN: 0009-9147