Focusing on the clinical impact of standardization of creatinine measurements: a report by the EFCC Working Group on Creatinine Standardization

Abstract The recent campaign for standardization of creatinine measurements has been promoted to allow the widespread use of formulas for estimating the glomerular filtration rate (GFR). However, studies on trueness verification and measurement interferences still show disappointing interassay variation of serum creatinine results. Creatinine recalibration has major clinical consequences. In particular, in pediatrics where reference ranges for serum and plasma creatinine are low, calculation of the GFR is problematic when based on alkaline picrate methods because of method non-specificity and the lack of appropriate GFR estimating formulas. Therefore, enzymatic creatinine assays are preferred. In the near future, cystatin C might offer an interesting alternative for GFR estimation. For the calculation of drug doses, the Modification of Diet in Renal Disease study formula generally offers reliable data. However, attention has to be paid to the elderly. Also, the calculation of the Model for End-Stage Liver Disease score, which is used to prioritize patients for liver transplantation, may significantly be influenced by recalibration of creatinine assays. Creatinine restandardization may also affect the current guidelines for referral of chronic kidney disease patients to nephrologists.

[1]  R. Jansen,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 , 2008, Clinical chemistry and laboratory medicine.

[2]  J. Björk,et al.  The Lund–Malmö creatinine‐based glomerular filtration rate prediction equation for adults also performs well in children , 2008, Scandinavian journal of clinical and laboratory investigation.

[3]  T. Barratt,et al.  Estimation of glomerular filtration rate from plasma creatinine concentration in children. , 1976, Archives of disease in childhood.

[4]  Tom Greene,et al.  Chronic Kidney Disease Epidemiology Collaboration. Using standardized serum creatinine values in the Modification of Diet in Renal Disease study equation for estimating glomerular filtration rate (Annals of Internal Medicine (2006) 145, (247-254)) , 2008 .

[5]  A. Levey,et al.  Measurement of renal function in chronic renal disease. , 1990, Kidney international.

[6]  G. Schwartz,et al.  A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine , 2004 .

[7]  M. Jaffé,et al.  Ueber den Niederschlag, welchen Pikrinsäure in normalem Harn erzeugt und über eine neue Reaction des Kreatinins. , 1886 .

[8]  Susan L Furth,et al.  New equations to estimate GFR in children with CKD. , 2009, Journal of the American Society of Nephrology : JASN.

[9]  J. Delanghe How to establish glomerular filtration rate in children , 2008, Scandinavian journal of clinical and laboratory investigation. Supplementum.

[10]  David Roth,et al.  A simplified equation to predict glomerular filtration rate from serum creatinine , 2000 .

[11]  U. Alon,et al.  Creatinine clearance following cimetidine for estimation of glomerular filtration rate , 1998, Pediatric Nephrology.

[12]  A. Irish,et al.  Estimation of glomerular filtration rate: does haemoglobin discriminate between ageing and true CKD? , 2009, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association.

[13]  C. Weykamp,et al.  Prime time for enzymatic creatinine methods in pediatrics. , 2009, Clinical chemistry.

[14]  C. Schmid,et al.  Comparison of drug dosing recommendations based on measured GFR and kidney function estimating equations. , 2009, American journal of kidney diseases : the official journal of the National Kidney Foundation.

[15]  M. Panteghini Enzymatic assays for creatinine: time for action. , 2008, Clinical chemistry and laboratory medicine.

[16]  W. van Biesen,et al.  The importance of standardization of creatinine in the implementation of guidelines and recommendations for CKD: implications for CKD management programmes. , 2006, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association.

[17]  A. Marchal,et al.  Comparaison des méthodes de dosage de la créatinine sérique , 2001 .

[18]  A. Killeen,et al.  Creatinine measurement: state of the art in accuracy and interlaboratory harmonization. , 2005, Archives of pathology & laboratory medicine.

[19]  A. Kallner,et al.  How does the MDRD Study equation compare with serum creatinine in routine healthcare? Anatomy of MDRD‐eGFR , 2008, Scandinavian journal of clinical and laboratory investigation. Supplementum.

[20]  T. Therneau,et al.  A model to predict survival in patients with end‐stage liver disease , 2001 .

[21]  J. Henny,et al.  Reference intervals for serum creatinine concentrations: assessment of available data for global application. , 2008, Clinical chemistry.

[22]  C. Schmid,et al.  A new equation to estimate glomerular filtration rate. , 2009, Annals of internal medicine.

[23]  V. Lindström,et al.  Standardization of Cystatin C: Development of primary and secondary reference preparations , 2008, Scandinavian journal of clinical and laboratory investigation. Supplementum.

[24]  G. Roberts,et al.  Modified diet in renal disease method overestimates renal function in selected elderly patients. , 2009, Age and ageing.

[25]  R. Vanholder,et al.  Reevaluation of formulas for predicting creatinine clearance in adults and children, using compensated creatinine methods. , 2003, Clinical chemistry.

[26]  T. Greene,et al.  Performance of the modification of diet in renal disease and Cockcroft-Gault equations in the estimation of GFR in health and in chronic kidney disease. , 2005, Journal of the American Society of Nephrology : JASN.

[27]  F. Dekker,et al.  Performance of the Cockcroft-Gault, MDRD, and new CKD-EPI formulas in relation to GFR, age, and body size. , 2010, Clinical journal of the American Society of Nephrology : CJASN.

[28]  D. J. Langford,et al.  A simple estimate of glomerular filtration ratein full-term infants during the first year of life* , 1984 .

[29]  D. Parry Use of single-value protein compensation of the Jaffe creatinine assay contributes to clinically significant inaccuracy in results. , 2008, Clinical chemistry.

[30]  F. Dati,et al.  The New European Directive on in vitro Diagnostics , 2003, Clinical chemistry and laboratory medicine.

[31]  M Panteghini,et al.  Standardization in laboratory medicine: new challenges. , 2005, Clinica chimica acta; international journal of clinical chemistry.

[32]  K. Fujiwara,et al.  Difference of carboplatin clearance estimated by the Cockroft-Gault, Jelliffe, Modified-Jelliffe, Wright or Chatelut formula. , 2005, Gynecologic oncology.

[33]  R. Zinck,et al.  Cystatin C--a new marker of glomerular filtration rate in children independent of age and height. , 1998, Pediatrics.

[34]  F. Aucella,et al.  How to assess renal function in the geriatric population. , 2010, Journal of nephrology.

[35]  T. Hostetter,et al.  National kidney disease education program. , 2002, Journal of the American Society of Nephrology : JASN.

[36]  D. J. Langford,et al.  A simple estimate of glomerular filtration rate in full-term infants during the first year of life. , 1984, The Journal of pediatrics.

[37]  A. Levey,et al.  A More Accurate Method To Estimate Glomerular Filtration Rate from Serum Creatinine: A New Prediction Equation , 1999, Annals of Internal Medicine.

[38]  M. Mcmurdo,et al.  Including older people in clinical research , 2005, BMJ : British Medical Journal.

[39]  R. Dalton Serum creatinine and glomerular filtration rate: perception and reality. , 2010, Clinical chemistry.

[40]  L. Stevens,et al.  Clinical Implications of Estimating Equations for Glomerular Filtration Rate , 2004, Annals of Internal Medicine.

[41]  M. Welch,et al.  Certification of creatinine in a human serum reference material by GC-MS and LC-MS. , 2007, Clinical chemistry.

[42]  W. Miller Estimating equations for glomerular filtration rate in children: laboratory considerations. , 2009, Clinical chemistry.

[43]  R. Porte,et al.  Interlaboratory variability in assessment of the model of end‐stage liver disease score , 2008, Liver international : official journal of the International Association for the Study of the Liver.

[44]  A. Narva Assessment of kidney function for drug dosing. , 2009, Clinical chemistry.

[45]  G. Schwartz,et al.  A simple estimate of glomerular filtration rate in adolescent boys. , 1985, The Journal of pediatrics.

[46]  Tom Greene,et al.  Expressing the Modification of Diet in Renal Disease Study equation for estimating glomerular filtration rate with standardized serum creatinine values. , 2007, Clinical chemistry.