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04 July 2017
Article (Scientific journals)
Multicenter Evaluation of Cystatin C Measurement after Assay Standardization.
Bargnoux, Anne-Sophie; Pieroni, Laurence; Cristol, Jean-Paul et al.
2017 • In Clinical Chemistry, 63 (4), p. 833-841
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Keywords :
Cystatin C
Abstract :
[en] BACKGROUND: Since 2010, a certified reference material ERM-DA471/IFCC has been available for cystatin C (CysC). This study aimed to assess the sources of uncertainty in results for clinical samples measured using standardized assays. METHODS: This evaluation was performed in 2015 and involved 7 clinical laboratories located in France and Belgium. CysC was measured in a panel of 4 serum pools using 8 automated assays and a candidate isotope dilution mass spectrometry reference measurement procedure. Sources of uncertainty (imprecision and bias) were evaluated to calculate the relative expanded combined uncertainty for each CysC assay. Uncertainty was judged against the performance specifications derived from the biological variation model. RESULTS: Only Siemens reagents on the Siemens systems and, to a lesser extent, DiaSys reagents on the Cobas system, provided results that met the minimum performance criterion calculated according to the intraindividual and interindividual biological variations. Although the imprecision was acceptable for almost all assays, an increase in the bias with concentration was observed for Gentian reagents, and unacceptably high biases were observed for Abbott and Roche reagents on their own systems. CONCLUSIONS: This comprehensive picture of the market situation since the release of ERM-DA471/IFCC shows that bias remains the major component of the combined uncertainty because of possible problems associated with the implementation of traceability. Although some manufacturers have clearly improved their calibration protocols relative to ERM-DA471, most of them failed to meet the criteria for acceptable CysC measurements.
Disciplines :
Laboratory medicine & medical technology
Author, co-author :
Bargnoux, Anne-Sophie
Pieroni, Laurence
Cristol, Jean-Paul
Kuster, Nils
DELANAYE, Pierre  ;  Centre Hospitalier Universitaire de Liège - CHU > Service de néphrologie
Carlier, Marie-Christine
Fellahi, Soraya
Boutten, Anne
Lombard, Christine
Gonzalez-Antuna, Ana
Delatour, Vincent
Cavalier, Etienne  ;  Université de Liège > Département de pharmacie > Chimie médicale
Language :
English
Title :
Multicenter Evaluation of Cystatin C Measurement after Assay Standardization.
Publication date :
2017
Journal title :
Clinical Chemistry
ISSN :
0009-9147
eISSN :
1530-8561
Publisher :
American Association for Clinical Chemistry, Washington, United States - District of Columbia
Volume :
63
Issue :
4
Pages :
833-841
Peer reviewed :
Peer Reviewed verified by ORBi
Commentary :
(c) 2016 American Association for Clinical Chemistry.

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