Enzymatic but not compensated Jaffe methods reach the desirable specifications of NKDEP at normal levels of creatinine. results of the French multicentric evaluation
[en] The French Society of Clinical Biochemistry conducted this study to compare the accuracy and performances of the best creatinine enzymatic assays and the compensated Jaffe methods from the same manufacturers. Creatinine was measured in 3 serum pools with creatinine levels of 35.9±0.9 μmol/L, 74.4±1.4 μmol/L, and 97.9±1.7 μmol/L (IDMS determination). The performances of the assays (total error that includes the contribution of bias and imprecision) were evaluated using Monte-Carlo simulations and compared against desirable NKDEP criteria. The enzymatic assays always fell within the desirable total Error of 7.6%. By contrast, this requirement was never obtained for the compensated Jaffe methods at the critical level of 74.4±1.4 μmol/L. Only the compensated Jaffe creatinine on Olympus analyzer reached this specification at 35.9±0.9 and 97.9±1.7 μmol/L levels. This study demonstrates that, despite substantial improvement regarding traceability to the IDMS reference method and precision, compensated Jaffe creatinine methods, by contrast to enzymatic ones, do not reach the desirable specifications of NKDEP at normal levels of creatinine.
Disciplines :
Laboratory medicine & medical technology
Author, co-author :
Boutten, Anne
Bargnoux, Anne-Sophie
Carlier, Marie-Christine
DELANAYE, Pierre ; Centre Hospitalier Universitaire de Liège - CHU > Néphrologie
Rozet, Eric ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Delatour, Vincent
CAVALIER, Etienne ; Centre Hospitalier Universitaire de Liège - CHU > Chimie médicale
Hanser, Anne-Marie
Froissart, Marc
Cristol, Jean-Paul
Piéroni, Laurence
Société Française de Biologie clinique
Language :
English
Title :
Enzymatic but not compensated Jaffe methods reach the desirable specifications of NKDEP at normal levels of creatinine. results of the French multicentric evaluation
Myers G.L., Miller W.G., Coresh J., et al. Recommendations for improving serum creatinine measurement: a report from the laboratory working group of the national kidney disease education program. Clin Chem 2006, 52:5-18.
Cobbaert C.M., Baadenhuijsen H., Weykamp C.W. Prime time for enzymatic creatinine methods in pediatrics. Clin Chem 2009, 55:549-558.
Panteghini M. Enzymatic assays for creatinine: time for action. Scand J Clin Lab Invest Suppl 2008, 241:84-88.
Vickery S., Stevens P.E., Dalton R.N., Van Lente F., Lamb E.J. Does the ID-MS traceable MDRD equation work and is it suitable for use with compensated Jaffe and enzymatic creatinine assays?. Nephrol Dial Transplant 2006, 21:2439-2445.
Pieroni L., Delanaye P., Boutten A., et al. A multicentric evaluation of IDMS-traceable creatinine enzymatic assays. Clin Chim Acta 2011, 412:2070-2075.
Miller W.G. Specimen materials, target values and commutability for external quality assessment (proficiency testing) schemes. Clin Chim Acta 2003, 327:25-37.
Siekmann L. Determination of creatinine in human serum by isotope dilution-mass spectrometry. Definitive methods in clinical chemistry, IV. J Clin Chem Clin Biochem 1985, 23:137-144.
Delatour V., Lalere B., Dumont G., et al. Development of a reference method for creatinine measurement to improve diagnosis and follow-up of kidney disease. Rev Fr Métrologie 2011, 26:21-31.
Delanghe J.R., Cobbaert C., Galteau M.M., et al. Trueness verification of actual creatinine assays in the European market demonstrates a disappointing variability that needs substantial improvement. An international study in the framework of the EC4 creatinine standardization working group. Clin Chem Lab Med 2008, 46:1319-1325.
Greenberg N., Roberts W.L., Bachmann L.M., et al. Specificity characteristics of 7 commercial creatinine measurement procedures by enzymatic and Jaffe method principles. Clin Chem 2012, 58:391-401.
Junge W., Wilke B., Halabi A., Klein G. Determination of reference intervals for serum creatinine, creatinine excretion and creatinine clearance with an enzymatic and a modified Jaffe method. Clin Chim Acta 2004, 344:137-148.