Advances in Plasma Protein Standardization

Goodall, Shannon

doi:10.1177/000456329703400602

Cited by 11 publications

(7 citation statements)

References 13 publications

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“…Manufacturers referenced their calibrators and control materials to this CRM, and the betweenlaboratory variances for assays of most serum proteins became substantially lower (3)(4)(5). In external quality assurance schemes, the variability between measurement results obtained with all available methods for proteins such as TTR, AAT, AAG, TRF, IgG, IgA, IgM, and C3c ranges from about 5% to 8% (3 ).…”

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confidence: 99%

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

et al. 2010

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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.

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confidence: 99%

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

et al. 2010

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“…However, several analyses utilizing the results of national quality control programs have been published, including data from the UK (UK NEQAS), Sweden (EQAS), Germany (DKGC-RfS), the Czech Republic, and the US (CAP) (25)(26)(27)(28)(29). The data could not be pooled because of differences in the evaluation of data by the QA programs: various methods of outlier removal were used (with no trimming for the UK NEQAS), and some programs submitted individual laboratory results, while others (e.g., CAP) included only means, medians, and variances for individual assay groups (instruments and manufacturers) and for the overall data sets.…”

Section: The Effect Of Availability Of Reference Materials Erm-da470 mentioning

confidence: 99%

Standardizing plasma protein measurements worldwide: a challenging enterprise

Merlini

Blirup-Jensen

Johnson

et al. 2010

Clinical Chemistry and Laboratory Medicine

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The need for harmonizing laboratory results is particularly intense in the field of quantitative protein assays in consideration of the clinical impact of specific protein measurements and their relevance in monitoring disease. We report the efforts made by the Committee on Plasma Proteins of the IFCC Scientific Division to achieve worldwide comparability in plasma protein results. We focus on the production of reference materials and the methods applied throughout their production process. Particularly, the recent characterization of ERM-DA470k/IFCC and ERM-DA472/IFCC has demonstrated that it is possible to reproduce the earlier established procedures and thereby maintain standardization. Plasma protein reference materials have had a substantial impact in improving the harmonization of patient protein results that should translate into better patient care.

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“…CRM 470 was prepared under the auspices of the IFCC Committee on Plasma Proteins and released for sale in 1993 by the Bureau Communitaire de Référence (Community Bureau of Reference; BCR) in Europe and in 1994 by the College of American Pathologists (CAP), in the latter case as the Reference Preparation for Proteins in Human Serum, or RPPHS. Several subsequent studies have shown a reduction in among-manufacturer (4,5) and among-laboratory (6)(7)(8) variance when assays are referenced against CRM 470 but that some bias persists, in some cases increasing with time (9).…”

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confidence: 99%

Effect of Certified Reference Material 470 (CRM 470) on National Quality Assurance Programs for Serum Proteins in Europe

Johnson

Whicher²

2001

Clinical Chemistry and Laboratory Medicine

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The introduction of the international reference material for serum proteins, CRM 470, has resulted in significant reduction of the among-laboratory variance for most proteins assayed in European national quality assurance programs. In general, the CVs have decreased by 5 to 65%. However, both among- and within-manufacturer variances in many cases remain unacceptably high. In addition, concentration-dependent differences in variance and bias are present for some proteins. Although some variance will persist, reducing variance and bias to levels required for the institution of universal reference ranges will necessitate more accurate transfer of values to calibrants and controls and improved calibration curve fitting by manufacturers, as well as better quality control within laboratories.

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Advances in Plasma Protein Standardization

Cited by 11 publications

References 13 publications

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

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

Standardizing plasma protein measurements worldwide: a challenging enterprise

Effect of Certified Reference Material 470 (CRM 470) on National Quality Assurance Programs for Serum Proteins in Europe

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