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Special Report |
1 Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA.
2 Department of Pathology, Virginia Commonwealth University, Richmond, VA.
3 Department of Epidemiology, Johns Hopkins University, Baltimore, MD.
4 Department of Science and Technology, Laboratory Corporation of America, Elon, NC.
5 Ortho Clinical Diagnostics, Rochester, NY.
6 Department of Quantitative Health Science, Cleveland Clinic Foundation, Cleveland, OH.
7 National Kidney Disease Education Program, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD.
8 Division of Nephrology, Tufts New England Medical Center, Boston, MA.
9 Department of Clinical Sciences "Luigi Sacco", University of Milan, Milan, Italy.
10 Chemical Science and Technology Laboratory, National Institute of Standards and Technology, Gaithersburg, MD.
11 Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN.
aAddress correspondence to this author at: Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA 30341. Fax 770-488-4192; e-mail GMyers{at}cdc.gov.
Background: Reliable serum creatinine measurements in glomerular filtration rate (GFR) estimation are critical to ongoing global public health efforts to increase the diagnosis and treatment of chronic kidney disease (CKD). We present an overview of the commonly used methods for the determination of serum creatinine, method limitations, and method performance in conjunction with the development of analytical performance criteria. Available resources for standardization of serum creatinine measurement are discussed, and recommendations for measurement improvement are given.
Methods: The National Kidney Disease Education Program (NKDEP) Laboratory Working Group reviewed problems related to serum creatinine measurement for estimating GFR and prepared recommendations to standardize and improve creatinine measurement.
Results: The NKDEP Laboratory Working Group, in collaboration with international professional organizations, has developed a plan that enables standardization and improved accuracy (trueness) of serum creatinine measurements in clinical laboratories worldwide that includes the use of the estimating equation for GFR based on serum creatinine concentration that was developed from the Modification of Diet in Renal Disease (MDRD) study.
Conclusions: The current variability in serum creatinine measurements renders all estimating equations for GFR, including the MDRD Study equation, less accurate in the normal and slightly increased range of serum creatinine concentrations [<133 µmol/L (1.5 mg/dL)], which is the relevant range for detecting CKD [<60 mL · min–1 · (1.73 m2)–1]. Many automated routine methods for serum creatinine measurement meet or exceed the required precision; therefore, reduction of analytical bias in creatinine assays is needed. Standardization of calibration does not correct for analytical interferences (nonspecificity bias). The bias and nonspecificity problems associated with some of the routine methods must be addressed.
The following articles in journals at HighWire Press have cited this article:
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  A. Kukla, Y. El-Shahawi, E. Leister, B. Kasiske, M. Mauer, A. Matas, and H. N. Ibrahim GFR-estimating models in kidney transplant recipients on a steroid-free regimen Nephrol. Dial. Transplant., January 29, 2010; (2010): gfp668v1 - gfp668. [Abstract] [Full Text] [PDF]
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J. Zavada, E. Hoste, R. Cartin-Ceba, P. Calzavacca, O. Gajic, G. Clermont, R. Bellomo, J. A. Kellum, and for the AKI6 investigators A comparison of three methods to estimate baseline creatinine for RIFLE classification Nephrol. Dial. Transplant., January 25, 2010; (2010): gfp766v1 - gfp766. [Abstract] [Full Text] [PDF]
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 A. Mathew, M. Eliasziw, P.J. Devereaux, J. G. Merino, H. J.M. Barnett, A. X. Garg, and for the North American Symptomatic Carotid Endarte Carotid Endarterectomy Benefits Patients with CKD and Symptomatic High-Grade Stenosis J. Am. Soc. Nephrol., January 1, 2010; 21(1): 145 - 152. [Abstract] [Full Text] [PDF]
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N. L. Korpi-Steiner, E. E. Williamson, and B. S. Karon Comparison of Three Whole Blood Creatinine Methods for Estimation of Glomerular Filtration Rate Before Radiographic Contrast Administration Am J Clin Pathol, December 1, 2009; 132(6): 920 - 926. [Abstract] [Full Text] [PDF]
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 Q.-P. Wang, J.-W. Gu, X.-H. Zhan, H. Li, and X.-H. Luo Assessment of glomerular filtration rate by serum cystatin C in patients undergoing coronary artery bypass grafting Ann Clin Biochem, November 1, 2009; 46(6): 495 - 500. [Abstract] [Full Text] [PDF]
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 G. J. Schwartz and D. F. Work Measurement and Estimation of GFR in Children and Adolescents Clin. J. Am. Soc. Nephrol., November 1, 2009; 4(11): 1832 - 1843. [Abstract] [Full Text] [PDF]
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 A. K. Saenger, C. Lockwood, C. L. Snozek, T. C. Milz, B. S. Karon, M. G. Scott, and A. S. Jaffe Catecholamine Interference in Enzymatic Creatinine Assays Clin. Chem., September 1, 2009; 55(9): 1732 - 1736. [Abstract] [Full Text] [PDF]
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 L. Hui, W. Ge-ge, L. Zhiyue, and G. Yanan Association Analysis of Biological Variations in Different Routinely Measured Biochemical Parameters in Healthy Subjects Lab Med, August 1, 2009; 40(8): 474 - 477. [Abstract] [Full Text] [PDF]
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 B. R. Herts, N. Sharma, M. Lieber, M. Freire, D. A. Goldfarb, and E. D. Poggio Estimating Glomerular Filtration Rate in Kidney Donors: A Model Constructed with Renal Volume Measurements from Donor CT Scans1 Radiology, July 1, 2009; 252(1): 109 - 116. [Abstract] [Full Text] [PDF]
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G. Wolf, N. Muller, M. Busch, G. Eidner, C. Kloos, W. Hunger-Battefeld, and U. A Muller Diabetic foot syndrome and renal function in type 1 and 2 diabetes mellitus show close association Nephrol. Dial. Transplant., June 1, 2009; 24(6): 1896 - 1901. [Abstract] [Full Text] [PDF]
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J. C. Seegmiller, D. R. Barnidge, B. E. Burns, T. S. Larson, J. C. Lieske, and R. Kumar Quantification of Urinary Albumin by Using Protein Cleavage and LC-MS/MS Clin. Chem., June 1, 2009; 55(6): 1100 - 1107. [Abstract] [Full Text] [PDF]
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H. W. Vesper and L. M. Thienpont Traceability in Laboratory Medicine Clin. Chem., June 1, 2009; 55(6): 1067 - 1075. [Abstract] [Full Text] [PDF]
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B. R. Herts, N. Sharma, M. Lieber, M. Freire, D. A. Goldfarb, and E. D. Poggio Estimating Glomerular Filtration Rate in Kidney Donors: A Model Constructed with Renal Volume Measurements from Donor CT Scans Radiology, May 12, 2009; (2009) 2521081873. [Abstract] [Full Text]
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S. Song, M. Meyer, T. R. Turk, B. Wilde, T. Feldkamp, R. Assert, K. Wu, A. Kribben, and O. Witzke Serum cystatin C in mouse models: a reliable and precise marker for renal function and superior to serum creatinine Nephrol. Dial. Transplant., April 1, 2009; 24(4): 1157 - 1161. [Abstract] [Full Text] [PDF]
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G. J. Schwartz, A. Munoz, M. F. Schneider, R. H. Mak, F. Kaskel, B. A. Warady, and S. L. Furth New Equations to Estimate GFR in Children with CKD J. Am. Soc. Nephrol., March 1, 2009; 20(3): 629 - 637. [Abstract] [Full Text] [PDF]
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C. M. Cobbaert, H. Baadenhuijsen, and C. W. Weykamp Prime Time for Enzymatic Creatinine Methods in Pediatrics Clin. Chem., March 1, 2009; 55(3): 549 - 558. [Abstract] [Full Text] [PDF]
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S. Cottone, G. Mule, M. Guarneri, A. Palermo, M. C. Lorito, R. Riccobene, R. Arsena, F. Vaccaro, A. Vadala, E. Nardi, et al. Endothelin-1 and F2-isoprostane relate to and predict renal dysfunction in hypertensive patients Nephrol. Dial. Transplant., February 1, 2009; 24(2): 497 - 503. [Abstract] [Full Text] [PDF]
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 M. P. Moranville and H. R. Jennings Implications of using modification of diet in renal disease versus Cockcroft-Gault equations for renal dosing adjustments Am. J. Health Syst. Pharm., January 15, 2009; 66(2): 154 - 161. [Abstract] [Full Text] [PDF]
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A M. Peters, N. J Bird, I. Halsall, C. Peters, and A R. Michell Evaluation of the Modification of Diet in Renal Disease equation (eGFR) against simultaneous, dual-marker multi-sample measurements of glomerular filtration rate Ann Clin Biochem, January 1, 2009; 46(1): 58 - 64. [Abstract] [Full Text] [PDF]
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 K. S. Heffernan, S. Y. Jae, K. R. Wilund, J. A. Woods, and B. Fernhall Racial differences in central blood pressure and vascular function in young men Am J Physiol Heart Circ Physiol, December 1, 2008; 295(6): H2380 - H2387. [Abstract] [Full Text] [PDF]
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H. E. van Deventer, J. A. George, J. E. Paiker, P. J. Becker, and I. J. Katz Estimating Glomerular Filtration Rate in Black South Africans by Use of the Modification of Diet in Renal Disease and Cockcroft-Gault Equations Clin. Chem., July 1, 2008; 54(7): 1197 - 1202. [Abstract] [Full Text] [PDF]
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B. R. Herts, E. Schneider, E. D. Poggio, N. A. Obuchowski, and M. E. Baker Identifying Outpatients with Renal Insufficiency before Contrast-enhanced CT by Using Estimated Glomerular Filtration Rates versus Serum Creatinine Levels Radiology, July 1, 2008; 248(1): 106 - 113. [Abstract] [Full Text] [PDF]
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 A.-M. Cote, M. A Brown, E. Lam, P. v. Dadelszen, T. Firoz, R. M Liston, and L. A Magee Diagnostic accuracy of urinary spot protein:creatinine ratio for proteinuria in hypertensive pregnant women: systematic review BMJ, May 3, 2008; 336(7651): 1003 - 1006. [Abstract] [Full Text] [PDF]
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A. Ortiz, J. P. Oliveira, S. Waldek, D. G. Warnock, B. Cianciaruso, C. Wanner, and on behalf of the Fabry Registry Nephropathy in males and females with Fabry disease: cross-sectional description of patients before treatment with enzyme replacement therapy Nephrol. Dial. Transplant., May 1, 2008; 23(5): 1600 - 1607. [Abstract] [Full Text] [PDF]
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J. Coresh, L. A. Stevens, and A. S. Levey Chronic kidney disease is common: What do we do next? Nephrol. Dial. Transplant., April 1, 2008; 23(4): 1122 - 1125. [Full Text] [PDF]
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R. P Barbagallo, N. Boley, G. Holcombe, S. Merson, C. Mussell, C. Pritchard, P. Stokes, S. Wood, D. Ducroq, and A. Thomas Production and certification of four frozen human serum certified reference materials containing creatinine and electrolytes Ann Clin Biochem, March 1, 2008; 45(2): 160 - 166. [Abstract] [Full Text] [PDF]
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B. G. Jaar, R. Khatib, L. Plantinga, L. E. Boulware, and N. R. Powe Principles of Screening for Chronic Kidney Disease Clin. J. Am. Soc. Nephrol., March 1, 2008; 3(2): 601 - 609. [Full Text] [PDF]
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F. Ceriotti, J. C. Boyd, G. Klein, J. Henny, J. Queralto, V. Kairisto, M. Panteghini, and on behalf of the IFCC Committee on Reference Inter Reference Intervals for Serum Creatinine Concentrations: Assessment of Available Data for Global Application Clin. Chem., March 1, 2008; 54(3): 559 - 566. [Abstract] [Full Text] [PDF]
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 H. Bang, M. Mazumdar, L. M. Kern, D. A. Shoham, P. A. August, and A. V. Kshirsagar Validation and Comparison of a Novel Screening Guideline for Kidney Disease: KEEPing SCORED Arch Intern Med, February 25, 2008; 168(4): 432 - 435. [Full Text] [PDF]
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 J-P. Braun, E. Cabe, A. Geffre, H. P. Lefebvre, and C. Trumel Comparison of plasma creatinine values measured by different veterinary practices Vet Rec., February 16, 2008; 162(7): 215 - 216. [Full Text] [PDF]
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L. Ford and J. Berg Delay in separating blood samples affects creatinine measurement using the Roche kinetic Jaffe method Ann Clin Biochem, January 1, 2008; 45(1): 83 - 87. [Abstract] [Full Text] [PDF]
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G. Dimeski, B. McWhinney, B. Jones, R. Mason, and A. Carter Extent of bilirubin interference with Beckman creatinine methods Ann Clin Biochem, January 1, 2008; 45(1): 91 - 92. [Abstract] [Full Text] [PDF]
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M. Tidman, P. Sjostrom, and I. Jones A Comparison of GFR estimating formulae based upon s-cystatin C and s-creatinine and a combination of the two Nephrol. Dial. Transplant., January 1, 2008; 23(1): 154 - 160. [Abstract] [Full Text] [PDF]
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D. M. Parry Use of Single-Value Protein Compensation of the Jaffe Creatinine Assay Contributes to Clinically Significant Inaccuracy in Results Clin. Chem., January 1, 2008; 54(1): 215 - 216. [Full Text] [PDF]
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P. Komenda, M. Beaulieu, D. Seccombe, and A. Levin Regional Implementation of Creatinine Measurement Standardization J. Am. Soc. Nephrol., January 1, 2008; 19(1): 164 - 169. [Abstract] [Full Text] [PDF]
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R. Inagi, Y. Izuhara, N. Tominaga, M. Nangaku, K. Kurokawa, and T. Miyata Establishment of a sandwich ELISA for human megsin, a kidney-specific serine protease inhibitor Nephrol. Dial. Transplant., November 1, 2007; 22(11): 3311 - 3317. [Abstract] [Full Text] [PDF]
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 E. J. Lamb, M. C. Webb, and S. E O'Riordan Using the modification of diet in renal disease (MDRD) and Cockcroft and Gault equations to estimate glomerular filtration rate (GFR) in older people Age Ageing, November 1, 2007; 36(6): 689 - 692. [Full Text] [PDF]
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A. Narva Screening Is Part of Kidney Disease Education Clin. J. Am. Soc. Nephrol., November 1, 2007; 2(6): 1352 - 1354. [Full Text] [PDF]
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R. J. Falk, L. L. Hamm, M. A. Josephson, S. Adler, and A. K. Singh The Nephrology Quiz and Questionnaire: 2006 Clin. J. Am. Soc. Nephrol., November 1, 2007; 2(6): 1375 - 1388. [Full Text] [PDF]
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L. A. Stevens, J. Coresh, H. I. Feldman, T. Greene, J. P. Lash, R. G. Nelson, M. Rahman, A. E. Deysher, Y. Zhang, C. H. Schmid, et al. Evaluation of the Modification of Diet in Renal Disease Study Equation in a Large Diverse Population J. Am. Soc. Nephrol., October 1, 2007; 18(10): 2749 - 2757. [Abstract] [Full Text] [PDF]
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W. G. Miller, G. L. Myers, and J. H. Eckfeldt The authors of the article cited above respond: Clin. Chem., September 1, 2007; 53(9): 1716 - 1717. [Full Text] [PDF]
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J. S. Krouwer A Recommended Improvement for Specifying and Estimating Serum Creatinine Performance Clin. Chem., September 1, 2007; 53(9): 1715 - 1716. [Full Text] [PDF]
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N. G. Dodder, S. S.-C. Tai, L. T. Sniegoski, N. F. Zhang, and M. J. Welch Certification of Creatinine in a Human Serum Reference Material by GC-MS and LC-MS Clin. Chem., September 1, 2007; 53(9): 1694 - 1699. [Abstract] [Full Text] [PDF]
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 Y. Maaravi, M. Bursztyn, R. Hammerman-Rozenberg, and J. Stessman Glomerular filtration rate estimation and mortality in an elderly population QJM, July 1, 2007; 100(7): 441 - 449. [Abstract] [Full Text] [PDF]
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P. D Giles and D. A Fitzmaurice Formula estimation of glomerular filtration rate: have we gone wrong? BMJ, June 9, 2007; 334(7605): 1198 - 1200. [Full Text] [PDF]
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F. J. Hoek, J. C. Korevaar, F. W. Dekker, E. W. Boeschoten, and R. T. Krediet Estimation of residual glomerular filtration rate in dialysis patients from the plasma cystatin C level Nephrol. Dial. Transplant., June 1, 2007; 22(6): 1633 - 1638. [Abstract] [Full Text] [PDF]
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 A. Viljoen and P. J Twomey True or not: uncertainty of laboratory results J. Clin. Pathol., June 1, 2007; 60(6): 587 - 588. [Full Text] [PDF]
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A. S. Levey, J. Coresh, T. Greene, J. Marsh, L. A. Stevens, J. W. Kusek, F. Van Lente, and for Chronic Kidney Disease Epidemiology Collaborat Expressing the Modification of Diet in Renal Disease Study Equation for Estimating Glomerular Filtration Rate with Standardized Serum Creatinine Values Clin. Chem., April 1, 2007; 53(4): 766 - 772. [Abstract] [Full Text] [PDF]
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I. H. de Boer and M. W. Steffes Glomerular Filtration Rate and Albuminuria: Twin Manifestations of Nephropathy in Diabetes J. Am. Soc. Nephrol., April 1, 2007; 18(4): 1036 - 1037. [Full Text] [PDF]
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W. J. Spruill, W. E. Wade, and H. H. Cobb III Estimating glomerular filtration rate with a modification of diet in renal disease equation: Implications for pharmacy Am. J. Health Syst. Pharm., March 15, 2007; 64(6): 652 - 660. [Full Text] [PDF]
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L. Pucci, S. Triscornia, D. Lucchesi, C. Fotino, G. Pellegrini, E. Pardini, R. Miccoli, S. Del Prato, and G. Penno Cystatin C and Estimates of Renal Function: Searching for a Better Measure of Kidney Function in Diabetic Patients Clin. Chem., March 1, 2007; 53(3): 480 - 488. [Abstract] [Full Text] [PDF]
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 W. E Wade and W. J Spruill New Serum Creatinine Assay Standardization: Implications for Drug Dosing Ann. Pharmacother., March 1, 2007; 41(3): 475 - 480. [Abstract] [Full Text] [PDF]
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H. Bang, S. Vupputuri, D. A. Shoham, P. J. Klemmer, R. J. Falk, M. Mazumdar, D. Gipson, R. E. Colindres, and A. V. Kshirsagar SCreening for Occult REnal Disease (SCORED): A Simple Prediction Model for Chronic Kidney Disease Arch Intern Med, February 26, 2007; 167(4): 374 - 381. [Abstract] [Full Text] [PDF]
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 W. Van Biesen, D. De Bacquer, F. Verbeke, J. Delanghe, N. Lameire, and R. Vanholder The glomerular filtration rate in an apparently healthy population and its relation with cardiovascular mortality during 10 years Eur. Heart J., February 2, 2007; 28(4): 478 - 483. [Abstract] [Full Text] [PDF]
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P. M. Rainey Automatic Reporting of Estimated Glomerular Filtration Rate--Jumping the Gun? Clin. Chem., December 1, 2006; 52(12): 2184 - 2187. [Full Text] [PDF]
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A. S. Levey, L. A. Stevens, and T. Hostetter Automatic Reporting of Estimated Glomerular Filtration Rate--Just What the Doctor Ordered Clin. Chem., December 1, 2006; 52(12): 2188 - 2193. [Full Text] [PDF]
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 B. Sprangers, P. Evenepoel, and Y. Vanrenterghem Late Referral of Patients With Chronic Kidney Disease: No Time to Waste Mayo Clin. Proc., November 1, 2006; 81(11): 1487 - 1494. [Abstract] [Full Text] [PDF]
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S. Vickery, P. E. Stevens, R. N. Dalton, F. van Lente, and E. J. Lamb Does the ID-MS traceable MDRD equation work and is it suitable for use with compensated Jaffe and enzymatic creatinine assays? Nephrol. Dial. Transplant., September 1, 2006; 21(9): 2439 - 2445. [Abstract] [Full Text] [PDF]
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 A. S. Levey, J. Coresh, T. Greene, L. A. Stevens, Y. Zhang, S. Hendriksen, J. W. Kusek, F. Van Lente, and for the Chronic Kidney Disease Epidemiology Collab Using Standardized Serum Creatinine Values in the Modification of Diet in Renal Disease Study Equation for Estimating Glomerular Filtration Rate Ann Intern Med, August 15, 2006; 145(4): 247 - 254. [Abstract] [Full Text] [PDF]
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M. Tonelli, F. Sacks, M. Pfeffer, Z.H. Gao, G. Curhan, for the Cholesterol and Recurrent Events (CARE) Tr, P. Rossing, K. Rossing, P. Gaede, O. Pedersen, et al. Serum Phosphate: A Novel Cardiovascular Risk Factor Even in Nonrenal Patients: Relation between Serum Phosphate Level and Cardiovascular Event Rate in People with Coronary Disease. Circulation 112: 2627-2633, 2005 J. Am. Soc. Nephrol., August 1, 2006; 17(8): 2077 - 2085. [Full Text] [PDF]
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 G Banfi, M Del Fabbro, and G Lippi Relation between serum creatinine and body mass index in elite athletes of different sport disciplines * Commentary Br. J. Sports Med., August 1, 2006; 40(8): 675 - 678. [Abstract] [Full Text] [PDF]
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 L. A. Stevens, J. Coresh, T. Greene, and A. S. Levey Assessing kidney function--measured and estimated glomerular filtration rate. N. Engl. J. Med., June 8, 2006; 354(23): 2473 - 2483. [Full Text] [PDF]
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M.S. MacGregor, D.E. Boag, and A. Innes Chronic kidney disease: evolving strategies for detection and management of impaired renal function QJM, June 1, 2006; 99(6): 365 - 375. [Abstract] [Full Text] [PDF]
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P. Delanaye, E. Cavalier, J. P. Chapelle, and J. M. Krzesinski Importance of the creatinine calibration in the estimation of GFR by MDRD equation Nephrol. Dial. Transplant., April 1, 2006; 21(4): 1130 - 1130. [Full Text] [PDF]
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A. Grubb and G. Nordin Notable Steps in Obtaining Improved Estimates for Glomerular Filtration Rate Clin. Chem., February 1, 2006; 52(2): 169 - 170. [Full Text] [PDF]
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