Effects of analytic variations in creatinine measurements on the classification of renal disease using estimated glomerular filtration rate (eGFR)

Klee, George G.; Schryver, Patricia G.; Saenger, Amy K.; Larson, Timothy S.

doi:10.1515/cclm.2007.168

Cited by 21 publications

(11 citation statements)

References 13 publications

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“…The presence of high glucose concentrations in plasma will result in either under or over estimation of GFR, according to the method used and may also lead to errors in classification of CKD. For example, in their study, Klee et al 14 reported that a positive bias of 20 mol/L in creatinine measurement, resulted in a three-fold increase the number of patients with GFR value of <60 mL/min/1.73 m 2 .…”

Section: Discussionmentioning

confidence: 97%

Post-standardization of routine creatinine assays: are they suitable for clinical applications

et al. 2016

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Introduction Reliable serum creatinine measurements are of vital importance for the correct classification of chronic kidney disease and early identification of kidney injury. The National Kidney Disease Education Programme working group and other groups have defined clinically acceptable analytical limits for creatinine methods. The aim of this study was to re-evaluate the performance of routine creatinine methods in the light of these defined limits so as to assess their suitability for clinical practice. Method In collaboration with the Dutch External Quality Assurance scheme, six frozen commutable samples, with a creatinine concentration ranging from 80 to 239 μmol/L and traceable to isotope dilution mass spectrometry, were circulated to 91 laboratories in four European countries for creatinine measurement and estimated glomerular filtration rate calculation. Two out of the six samples were spiked with glucose to give high and low final concentrations of glucose. Results Results from 89 laboratories were analysed for bias, imprecision (%CV) for each creatinine assay and total error for estimated glomerular filtration rate. The participating laboratories used analytical instruments from four manufacturers; Abbott, Beckman, Roche and Siemens. All enzymatic methods in this study complied with the National Kidney Disease Education Programme working group recommended limits of bias of 5% above a creatinine concentration of 100 μmol/L. They also did not show any evidence of interference from glucose. In addition, they also showed compliance with the clinically recommended %CV of ≤4% across the analytical range. In contrast, the Jaffe methods showed variable performance with regard to the interference of glucose and unsatisfactory bias and precision. Conclusion Jaffe-based creatinine methods still exhibit considerable analytical variability in terms of bias, imprecision and lack of specificity, and this variability brings into question their clinical utility. We believe that clinical laboratories and manufacturers should work together to phase out the use of relatively non-specific Jaffe methods and replace them with more specific methods that are enzyme based.

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Section: Discussionmentioning

confidence: 97%

Post-standardization of routine creatinine assays: are they suitable for clinical applications

et al. 2016

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“…The impact of analytical performance characteristics of a creatinine method on eGFRcrea was demonstrated in the work by Klee et al 10 The same is true for cystatin C. Our study used creatinine and cystatin C tests traceable to international reference materials, which leads to low bias of both methods.…”

Section: T a B L E 1 Gfr Classification Stages According To Egfrs Andmentioning

confidence: 59%

Cystatin C measurement leads to lower metformin dosage in elderly type 2 diabetic patients

Skalický

Adamíková

2018

Basic Clin Pharma Tox

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The aim of this study was to provide evidence for the hypothesis that estimated glomerular filtration rate from serum Cystatin C (eGFRcys) is better to be determined for all elderly type 2 diabetes mellitus (T2DM) patients based on eGFRcys upward and downward reclassification rate for hypothetical metformin dose reduction by eGFRcys at the GFR decision point of 45 mL/min/1.73 m . A total of 265 consecutive T2DM elderly patients (age range 65-91 years) from outpatient diabetic clinic were included in the study. The Kidney Disease Improving Global Outcomes (KDIGO) guidelines for metformin dosing were strictly followed. Estimated glomerular filtration rate from serum creatinine (eGFRcrea) led to results of metformin eligibility. Each of the results of eGFRcrea-based eligibility was further compared to eGFRcys-based eligibility. Creatinine was measured by enzymatic method standardized against international reference material SRM 967. Cystatin C was determined by method traceable to DA ERM 471 international standard. eGFRcrea and eGFRcys were calculated according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations. A downward reclassification rate was higher than upward reclassification rate (31 vs 3, respectively; P < 0.0001). The median (IQR) eGFRcrea was higher than eGFRcys (73 (58-85) vs 63 (50-75) mL/min/1.73 m , respectively; P < 0.0001). eGFRcys reclassified significant proportion of patients with T2DM from metformin eligible CKD stages to less or non-eligible stages. The downward reclassification was more frequent in patients older than 80 years (P < 0.01). Cystatin C-based eGFR selects more complicated patients, where lower doses of metformin are possibly advisable. We recommend calculating both eGFRcrea and eGFRcys for metformin dosing in elderly patients with T2DM.

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“…In this study, the creatinine enzymatic IDMS-traceable assay used allowed to minimize the analytical bias on the study of agreement between the three methods than non-enzymatic creatinine determination [16].…”

Section: Discussionmentioning

confidence: 99%

KDIGO 2012 Clinical Practice Guideline CKD classification rules out creatinine clearance 24 hour urine collection?

Ognibene

Grandi

Lorubbio

et al. 2016

Clinical Biochemistry

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Effects of analytic variations in creatinine measurements on the classification of renal disease using estimated glomerular filtration rate (eGFR)

Cited by 21 publications

References 13 publications

Post-standardization of routine creatinine assays: are they suitable for clinical applications

Post-standardization of routine creatinine assays: are they suitable for clinical applications

Cystatin C measurement leads to lower metformin dosage in elderly type 2 diabetic patients

KDIGO 2012 Clinical Practice Guideline CKD classification rules out creatinine clearance 24 hour urine collection?

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