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

Zegers, Ingrid; Keller, Thomas; Schreiber, Wiebke; Sheldon, Joanna; Albertini, Riccardo; Blirup, Soren LU ; Johnson, Myron; Trapmann, Stefanie; Emons, Hendrik and Merlini, Giampaolo, et al. (2010) In Clinical Chemistry 56(12). p.1880-1888
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... (More)
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 (Less)
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Clinical Chemistry
volume
56
issue
12
pages
1880 - 1888
publisher
American Association for Clinical Chemistry
external identifiers
  • wos:000284759700018
  • scopus:78649819470
ISSN
0009-9147
DOI
10.1373/clinchem.2010.148809
language
English
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yes
id
e737efa0-fdb3-4c5e-a4b5-a068af5ee0ae (old id 1752265)
date added to LUP
2011-01-04 07:41:48
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2018-06-24 03:04:55
@article{e737efa0-fdb3-4c5e-a4b5-a068af5ee0ae,
  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 [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},
  author       = {Zegers, Ingrid and Keller, Thomas and Schreiber, Wiebke and Sheldon, Joanna and Albertini, Riccardo and Blirup, Soren and Johnson, Myron and Trapmann, Stefanie and Emons, Hendrik and Merlini, Giampaolo and Schimmel, Heinz},
  issn         = {0009-9147},
  language     = {eng},
  number       = {12},
  pages        = {1880--1888},
  publisher    = {American Association for Clinical Chemistry},
  series       = {Clinical Chemistry},
  title        = {Characterization of the New Serum Protein Reference Material ERM-DA470k/IFCC: Value Assignment by Immunoassay},
  url          = {http://dx.doi.org/10.1373/clinchem.2010.148809},
  volume       = {56},
  year         = {2010},
}