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      Routine serum creatinine measurements: how well do we perform?

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          Abstract

          Background

          The first aim of the study was to investigate the accuracy and intra-laboratory variation of serum creatinine measurements in clinical laboratories in Flanders. The second purpose was to check the effect of this variation in serum creatinine concentration results on the calculated estimated glomerular filtration rate (eGFR) and the impact on classification of patients into a chronic kidney disease (CKD) stage.

          Methods

          26 routine instruments were included, representing 13 different types of analyzers from 6 manufacturers and covering all current methodologies (Jaffe, compensated Jaffe, enzymatic liquid and dry chemistry methods). Target values of five serum pools (creatinine concentrations ranging from 35 to 934 μmol/L) were assigned by the gold standard method (ID-GC/MS).

          Results

          Intra-run CV (%) (n = 5) and bias (%) from the target values were higher for low creatinine concentrations. Especially Jaffe and enzymatic dry chemistry methods showed a higher error. The calculated eGFR values corresponding with the reported creatinine concentration ranges resulted in a different CKD classification in 47% of cases.

          Conclusions

          Although most creatinine assays claim to be traceable to the gold standard (ID-GC/MS), large inter-assay differences still exist. The inaccuracy in the lower concentration range is of particular concern and may lead to clinical misinterpretation when the creatinine-based eGFR of the patient is used for CKD staging. Further research to improve harmonization between methods is required.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s12882-015-0012-x) contains supplementary material, which is available to authorized users.

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          Most cited references 18

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          A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine.

          Based on statistical analysis of data in 186 children, a formula was derived which allows accurate estimation of glomerular filtration rate (GFR) from plasma creatinine and body lenght (GFR(ml/min/1.73 sq m) = 0.55 length (cm)/Per (mg/dl). Its application to clearance data in a separate group of 223 children reveals excellent agreement with GFR estimated by the Ccr (r = .935) or Cin (r = .905). This formula should be useful for adjusting dosages of drugs excreted by the kidney and detecting significant changes in renal function.
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            Does the ID-MS traceable MDRD equation work and is it suitable for use with compensated Jaffe and enzymatic creatinine assays?

            International recommendations suggest that measurement of serum creatinine should be supplemented with an estimate of glomerular filtration rate (GFR) using the Modification of Diet in Renal Disease (MDRD) study equation. One problem has been the lack of standardization of commercially available creatinine assays resulting in varying estimates of GFR. A revision of the MDRD equation offers traceability to a reference method. This study evaluates the use of isotope dilution mass spectrometry (ID-MS), the compensated Jaffe and enzymatic creatinine methods compared with the Beckman CX3 Jaffe assay used to derive the MDRD equation and investigates their impact on GFR estimation using both the original and ID-MS-traceable MDRD equations. Serum creatinine was measured in 277 patients by (i) ID-MS, (ii) a Roche enzymatic assay, (iii) a Roche compensated kinetic Jaffe assay and (iv) a Beckman CX3 kinetic Jaffe assay. Estimated GFR was calculated using the MDRD equations. The ID-MS (-7.5%), Roche enzymatic (-8.6%) and compensated kinetic Jaffe (-11.9%) assays were all negatively biased (P < 0.0001) compared with the Beckman CX3 assay, causing predictable, clinically significant, overestimation of GFR when the original MDRD equation is used. This positive bias was reduced (ID-MS 6.7 to 0.4%; enzymatic 8.8 to 3.4%; compensated kinetic Jaffe 13.7 to 7.1%) when GFRs were calculated using the ID-MS-traceable MDRD equation. Compensated assays that account for non-creatinine chromogen interference produce significantly higher estimates of GFR when using the original MDRD equation. Use of the ID-MS-traceable MDRD equation ameliorates this effect. There is good agreement between estimated GFR derived from the original MDRD equation using Beckman Astra CX3 data and estimated GFR derived from the new ID-MS-traceable MDRD equation using a local ID-MS creatinine assay. This suggests that the ID-MS-traceable MDRD equation may be reliably used with both ID-MS and true ID-MS-traceable creatinine assays without the requirement for standardization to the MDRD laboratory.
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              Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease

              (2012)
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                Author and article information

                Contributors
                liesbeth.hoste@kuleuven-kulak.be
                kathleen.deiteren@telenet.be
                hans.pottel@kuleuven-kulak.be
                nico.callewaert@azgroeninge.be
                f.martens@skynet.be
                Journal
                BMC Nephrol
                BMC Nephrol
                BMC Nephrology
                BioMed Central (London )
                1471-2369
                14 February 2015
                14 February 2015
                2015
                : 16
                Affiliations
                [ ]Interdisciplinary Research Facility Life Sciences, Katholieke Universiteit Leuven Campus Kortrijk, Kortrijk, Belgium
                [ ]Department of Clinical Chemistry and Toxicology, AZ Groeninge Hospital, Reepkaai 4, B8500 Kortrijk, Belgium
                Article
                12
                10.1186/s12882-015-0012-x
                4358903
                © Hoste et al.; licensee BioMed Central. 2015

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Categories
                Research Article
                Custom metadata
                © The Author(s) 2015

                Nephrology

                creatinine, external quality assessment, glomerular filtration rate

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