Comparison between IDMS-traceable Jaffe and enzymatic creatinine assays for estimation of glomerular filtration rate by the CKD-EPI equation in healthy and diabetic subjects

doi:10.1016/j.clinbiochem.2013.05.067

Clinical Biochemistry

Volume 46, Issue 15, October 2013, Pages 1423-1429

https://doi.org/10.1016/j.clinbiochem.2013.05.067 Get rights and content

Highlights

•
Renal function study conducted in healthy and diabetic adults
•
Creatinine measured by traceable Jaffe and enzymatic methods, and GFR by ⁵¹Cr-EDTA.
•
Jaffe and enzymatic creatinine methods showed adequate agreement in healthy adults.
•
In the presence of diabetes, the enzymatic method performed slightly better.

Abstract

Objectives

The aim of this paper was to compare the agreement between creatinine measured by Jaffe and enzymatic methods and their putative influence on eGFR as calculated by the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation in healthy and diabetic individuals.

Design and methods

Cross-sectional study conducted in 123 adult southern Brazilians with GFR > 60 mL/min/1.73 m² (53 patients with type 2 diabetes, 70 healthy volunteers). Mean age was 49 ± 16 years (range of 19–86). Most were female (55%) and white (83%). Creatinine was measured by a traceable Jaffe method (Modular P, Roche Diagnostic) and by an enzymatic method (CREA plus, Roche/Hitachi 917). GFR was measured by the ⁵¹Cr-EDTA single-injection method.

Results

Serum creatinine measured by the Jaffe and enzymatic methods was similar in healthy subjects (0.79 ± 0.16 vs. 0.79 ± 0.15 mg/dL, respectively, P = 0.76), and diabetic patients (0.96 ± 0.22 vs. 0.92 ± 0.29 mg/dL, respectively, P = 0.17). However, the correlation between the two methods was higher in the healthy group (r = 0.90 vs. 0.76, P < 0.001). The difference between Jaffe creatinine and enzymatic creatinine was < 10% in 63% of cases in the healthy group and 40% of cases in the diabetes group (P = 0.018). In the subset of patients with diabetes, eGFR based on enzymatic assay results showed better agreement with measured GFR than did eGFR based on Jaffe results.

Conclusion

Jaffe and enzymatic creatinine methods show adequate agreement in healthy subjects, but in the presence of diabetes, the enzymatic method performed slightly better.

Introduction

The National Kidney Foundation (NKF) defines chronic kidney disease (CKD) as the presence of structural or functional renal abnormalities for at least 3 months [1].

Two laboratory parameters, albuminuria and glomerular filtration rate (GFR), are the cornerstone for the diagnosis and classification of CKD [2]. Measured GFR is considered the reference method, but is restricted to special situations [3] because of its complexity and high cost. Hence, in daily clinical practice, estimation of GFR (eGFR) using equations based on serum creatinine levels adjusted for age, gender and ethnicity is the recommended approach for evaluation of renal function. Neither the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) nor the MDRD (Modification of Diet in Renal Disease) study equation is optimal across all populations and GFR ranges [4], [5], but the CKD-EPI equation appears to be superior for categorization of patients in terms of clinical risk [6]. The National Kidney Disease Education Program (NKDEP) has not made a recommendation on general implementation of this equation, since it is still being validated. While offering some improvement for eGFR between 60 and 120 mL/min/1.73 m², it is not clear that implementing CKD-EPI in place of MDRD equation would alter clinical detection or management of patients with CKD. However, a laboratory that reports eGFR numeric values > 60 mL/min/1.73 m² should consider using the CKD-EPI equation. (http://nkdep.nih.gov/lab-evaluation/gfr/estimating.shtml accessed January 17, 2013).

At present, it is formally recommended that laboratories routinely report eGFR when serum creatinine testing is requested [1]. An accurate measurement of serum creatinine forms the basis of compliance with these guidelines. Currently, most routine serum creatinine assays are based on the Jaffe reaction, a method first described in 1886 [7]. This method is widely used because of its simplicity and low cost. However, a number of studies have indicated that enzymatic methods tend to be superior to the Jaffe reaction because they are less subject to influence by interfering substances, especially in diabetic subjects [8], [9], [10], [11]. Enzymatic assays are considerably more expensive than the Jaffe method, which limits their wider implementation, especially in developing countries. Therefore, the aim of this paper was to compare the agreement between creatinine levels as measured by traceable Jaffe and enzymatic methods and the putative influence on eGFR calculated by the CKD-EPI equation in healthy subjects and type 2 diabetic patients.

Section snippets

Subjects

This cross-sectional study was conducted in a sample of individuals from Southern Brazil (healthy volunteers and type 2 diabetic patients) with GFR > 60 mL/min/1.73 m². Healthy individuals also had normal glucose tolerance and blood pressure levels. All subjects underwent evaluation of family history and personal medical history.

The exclusion criteria were BMI > 35 kg/m², history of cancer in the 5 years preceding study enrollment, and, for normal volunteers, use of drugs other than oral contraceptives

Results

The clinical and laboratory characteristics of the subjects at the time of enrollment are shown in Table 1. Diabetic patients were generally older and more predominantly male.

Serum creatinine levels measured by the Jaffe and enzymatic methods were similar in both the healthy (0.79 ± 0.16 vs. 0.79 ± 0.15 mg/dL, respectively, P = 0.76), and the diabetic (0.96 ± 0.22 vs. 0.92 ± 0.29 mg/dL, P = 0.17; Fig. 1) groups, and was significantly higher in the diabetic patients (P < 0.001), despite similar measured GFRs

Discussion

In this study, we demonstrated adequate agreement between creatinine levels measured by Jaffe and enzymatic methods in healthy subjects. However, in the diabetic patients, whose GFR was > 60 mL/min/1.73 m², the enzymatic method performed slightly better, and both creatinine methods largely underestimated measured GFR. Some authors have obtained reasonably good comparisons between the two creatinine methods [18], [19], [20], but a recent study highlights the greater interference of the presence of

Conflict of interest statement

The authors stated that there are no conflicts of interest regarding the publication of this article.

Acknowledgments

The authors would like to thank the Fundo de Incentivo à Pesquisa (FIPE) do Hospital de Clínicas de Porto Alegre for its financial support. AVC and AAS are supported by National Council for Scientific and Technological Development (CNPq) grants. We thank Vania Naomi Hirakata and Luciano Santos Guimarães for statistical analyses supervision.

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View all citing articles on Scopus

View full text

Comparison between IDMS-traceable Jaffe and enzymatic creatinine assays for estimation of glomerular filtration rate by the CKD-EPI equation in healthy and diabetic subjects

Highlights

Abstract

Objectives

Design and methods

Results

Conclusion

Introduction

Section snippets

Subjects

Results

Discussion

Conflict of interest statement

Acknowledgments

Kidney Int

Am J Kidney Dis

Am J Kidney Dis

Semin Nucl Med

Glomerular filtration rate measurement and prediction equations

Clin Chem Lab Med

Measured GFR as a confirmatory test for estimated GFR

J Am Soc Nephrol

Estimating equations for glomerular filtration rate in the era of creatinine standardization: a systematic review

Ann Intern Med

MDRD or CKD-EPI study equations for estimating prevalence of stage 3 CKD in epidemiological studies: which difference? Is this difference relevant?

BMC Nephrol

Serum creatinine as an index of renal function: new insights into old concepts

Clin Chem

Evaluation of an enzymatic method for determining creatinine in plasma

J Clin Pathol

A step forward in enzymatic measurement of creatinine

Clin Chem

Improvements in creatinine methodology: a critical assessment

Eur J Clin Chem Clin Biochem

Specificity characteristics of 7 commercial creatinine measurement procedures by enzymatic and Jaffe method principles

Clin Chem

Guidelines for the measurement of glomerular filtration rate using plasma sampling

Nucl Med Commun

Estimation of human body surface

Cancer Chemother Rep

Estimation of glomerular filtration rate from plasma clearance of 51-chromium edetic acid

Arch Dis Child

Effect of age and sex on glomerular filtration rate measured by 51Cr-EDTA

Braz J Med Biol Res

A new equation to estimate glomerular filtration rate

Ann Intern Med

Measuring agreement in method comparison studies

Stat Methods Med Res

Measurement of serum creatinine — current status and future goals

Clin Biochem Rev

Estimation of glomerular filtration rate from plasma clearance of ⁵¹-chromium edetic acid

Effect of age and sex on glomerular filtration rate measured by ⁵¹Cr-EDTA