[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 :
Médecine de laboratoire & technologie médicale
Auteur, co-auteur :
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
Langue du document :
Anglais
Titre :
Multicenter Evaluation of Cystatin C Measurement after Assay Standardization.
Date de publication/diffusion :
2017
Titre du périodique :
Clinical Chemistry
ISSN :
0009-9147
eISSN :
1530-8561
Maison d'édition :
American Association for Clinical Chemistry, Washington, Etats-Unis - District de Columbia
Volume/Tome :
63
Fascicule/Saison :
4
Pagination :
833-841
Peer reviewed :
Peer reviewed vérifié par ORBi
Commentaire :
(c) 2016 American Association for Clinical Chemistry.
Levey AS, Becker C, Inker LA. Glomerular filtration rate and albuminuria for detection and staging of acute and chronic kidney disease in adults: A systematic review. JAMA 2015; 313: 837-46.
Luo J, Wang LP, Hu HF, Zhang L, Li YL, Ai LM, et al. Cystatin C and cardiovascular or all-cause mortality risk in the general population: A meta-Analysis. Clin Chim Acta 2015; 450: 39-45.
Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int Suppl 2013; 3: 1-150.
Carville S, Wonderling D, Stevens P. Early identification and management of chronic kidney disease in adults: Summary of updated NICE guidance. BMJ 2014; 349: G4507.
Delanaye P, Cavalier E, Cristol JP, Delanghe JR. Calibration and precision of serum creatinine and plasma cystatin C measurement: Impact on the estimation of glomerular filtration rate. J Nephrol 2014; 27: 467-75.
Grubb A, Blirup-Jensen S, Lindström V, Schmidt C, Althaus H, Zegers I. First certified reference material for cystatin C in human serum ERM-DA471/IFCC. Clin Chem Lab Med 2010; 48: 1619-21.
Ebert N, Delanaye P, Shlipak M, Jakob O, Martus P, Bartel J, et al. Cystatin C standardization decreases assay variation and improves assessment of glomerular filtration rate. Clin Chim Acta 2016; 456: 115-21.
Eckfeldt JH, Karger AB, Miller WG, Rynders GP, Inker LA. Performance in measurement of serum cystatin C by laboratories participating in the College of American Pathologists 2014 CYS Survey. Arch Pathol Lab Med 2015; 139: 888-93.
González-Antuña A, Rodríguez-González P, Ohlendorf R, Henrion A, Delatour V, García Alonso JI. Determination of cystatin C in human serum by isotope dilution mass spectrometry using mass overlapping peptides. J Proteomics 2015; 112: 141-55.
Bargnoux AS, Kuster N, Delatour V, Delanaye P, González-Antuña A, Cristol JP, et al.; Société Française de Biologie Clinique. Reference method and reference material are necessary tools to reveal the variability of cystatin C assays. Arch Pathol Lab Med 2016; 140: 117-8.
CLSI. Preparation and validation of commutable frozen human serum pools as secondary reference materials for cholesterol measurement procedures; approved guideline. Document C37-A. Wayne (PA): CLSI; 1999.
Kragten J. Tutorial review. Calculating standard deviations and confidence intervals with a universally applicable spreadsheet technique. Analyst 1994; 119: 2161-5.
CLSI. Characterization and qualification of commutable reference materials for laboratory medicine; approved guideline. Document EP30-A (formerly C53-A). Wayne (PA): CLSI; 2010.
Sandberg S, Fraser CG, Horvath AR, Jansen R, Jones G, Oosterhuis W, et al. Defining analytical performance specifications: Consensus statement from the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine. Clin Chem Lab Med 2015; 53: 833-5.
Delanaye P, Cavalier E, Depas G, Chapelle JP, Krzesinski JM. New data on the intraindividual variation of cystatin C. Nephron Clin Pract 2008; 108: C246 -8.
Pasqualetti S, Infusino I, Carnevale A, Szoke D, Panteghini M. The calibrator value assignment protocol of the Abbott enzymatic creatinine assay is inadequate for ensuring suitable quality of serum measurements. Clin Chim Acta 2015; 450: 125-6.
Magnusson B, Näykki T, Hovind H, Krysell M. Handbook for calculation of measurement uncertainty in environmental laboratories. Nordtest report TR 537, 05/2003; 2003.
Infusino I, Braga F, Mozzi R, Valente C, Panteghini M. Is the accuracy of serum albumin measurements suitable for clinical application of the test Clin Chim Acta 2011; 412: 791-2.
CLSI. Evaluation of precision of quantitative measurement procedures; approved guideline. Document EP05-A3. Wayne (PA): CLSI; 2014.
Braga F, Panteghini M. Verification of in vitro medical diagnostics (IVD) metrological traceability: Responsibilities and strategies. Clin Chim Acta 2014; 432: 55-61.
Mueller L, Pruemper C. Performance in measurement of serum cystatin C by laboratories participating in the College of American Pathologists 2014 CYS Survey. Arch Pathol Lab Med 2016; 140: 207.
Eckfeldt JH, Inker LA, Miller WG. In reply. Arch Pathol Lab Med 2016; 140: 207-8.
Zhao Z, Sacks DB. Detrimental effects of not using international reference materials to calibrate cystatin C assays. Clin Chem 2016; 62: 410-1.
Bargnoux AS, Servel AC, Piéroni L, Dupuy AM, Badiou S, Garrigue V, et al. Accuracy of GFR predictive equations in renal transplantation: Validation of a new turbidimetric cystatin C assay on Architect c8000. Clin Biochem 2012; 45: 151-3.
Braga F, Infusino I, Panteghini M. Performance criteria for combined uncertainty budget in the implementation of metrological traceability. Clin Chem Lab Med 2015; 53: 905-12.
Topic E, Nikolac N, Panteghini M, Theodorsson E, Salvagno GL, Miler M, et al.Howto assess the quality of your analytical method Clin Chem Lab Med 2015; 53: 1707-18.
Delanaye P, Pieroni L, Abshoff C, Lutteri L, Chapelle JP, Krzesinski JM, et al. Analytical study of three cystatin C assays and their impact on cystatin C-based GFRprediction equations. Clin Chim Acta 2008; 398: 118-24.
White CA, Rule AD, Collier CP, Akbari A, Lieske JC, Lepage N et al. The impact of interlaboratory differences in cystatin C assay measurement on glomerular filtration rate estimation. Clin J Am Soc Nephrol 2011; 6: 2150-6.
