PDF
ePub
Citation
Print
Jongwon Oh, M.D., Hyung-Doo Park, M.D.
Abstract
Background
Creatinine (Cr) is a representative biomarker reflecting renal function. In this study, we compared serum Cr levels using Roche Modular D (Roche Diagnostics, Germany), Roche Cobas 8000 c702 (Roche Diagnostics), and AU5800 (Beckman Coulter, USA). In addition, we assessed the differences in Cr measurements using the Jaffe and enzymatic methods.
Methods
Precision, linearity, and methods were evaluated in accordance with CLSI guidelines. Serum Cr was measured by Modular D following the Jaffe method, and serum Cr was measured by Cobas 8000 c702 and AU5800, following the Jaffe and enzyme methods.
Results
All of the total coefficients of variations (CVs) were below 5%. Linearity was observed in the performance ranges evaluated (r>0.99, slope: 0.965 and 0.955). When Modular D and Cobas 8000c 702 were compared, the slope and y-intercept were 0.9928 (95% confidence interval [CI]: 0.9802 to 1.000) and -0.0156 (95% CI: -0.0200 to -0.0054), respectively. The slope and y-intercept were 0.9811 (95% CI: 0.9570 to 0.9951) and -0.0484 (95% CI: -0.0638 to -0.0297) when Modular D and Au5800 were compared. Serum Cr measured by Cobas 8000 c702 and AU5800 using the Jaffe method were 3.2% and 6.9% lower than the values measured by Modular D, respectively. Both Modular D and Cobas 8000 c702 showed acceptable accuracies.
Figures and Tables
Fig. 1
Scatter plots and difference plots comparing creatinine measurements obtained using Modular D (Jaffe) with those obtained using Cobas 8000 c702 (Jaffe and enzymatic) and AU5800 (Jaffe and enzymatic). (A) Modular D with Cobas 8000 c702 (Jaffe), (B) Modular D with AU5800 (Jaffe), (C) Modular D with Cobas 8000 c702 (enzymatic), (D) Modular D with Au5800 (enzymatic), (E) Cobas 8000 c702 (Jaffe) with Cobas 8000 c702 (enzymatic), (F) AU5800 (Jaffe) with AU5800 (enzymatic).
References
1. Stevens LA, Coresh J, Greene T, Levey AS. Assessing kidney function–measured and estimated glomerular filtration rate. N Engl J Med. 2006; 354:2473–2483.
2. Stevens LA, Levey AS. Measured GFR as a confirmatory test for estimated GFR. J Am Soc Nephrol. 2009; 20:2305–2313.
3. Welch MJ, Cohen A, Hertz HS, Ng KJ, Schaffer R, Van der, et al. Determination of serum creatinine by isotope dilution mass spectrometry as a candidate definitive method. Anal Chem. 1986; 58:1681–1685.
4. Armbruster D, Miller RR. The Joint Committee for Traceability in Laboratory Medicine (JCTLM): a global approach to promote the standardisation of clinical laboratory test results. Clin Biochem Rev. 2007; 28:105–113.
5. Peake M, Whiting M. Measurement of serum creatinine–current status and future goals. Clin Biochem Rev. 2006; 27:173–184.
6. Miller WG, Myers GL, Ashwood ER, Killeen AA, Wang E, Thienpont LM, et al. Creatinine measurement: state of the art in accuracy and interlaboratory harmonization. Arch Pathol Lab Med. 2005; 129:297–304.
7. Myers GL, Miller WG, Coresh J, Fleming J, Greenberg N, Greene T, et al. Recommendations for improving serum creatinine measurement: a report from the Laboratory Working Group of the National Kidney Disease Education Program. Clin Chem. 2006; 52:5–18.
8. Clinical and Laboratory Standards Institute. Evaluation of precision of quantitative measurement procedures; Approved guideline-Third edition. CLSI document EP05-A3. Wayne, PA: Clinical and Laboratory Standards Institute;2014.
9. Clinical and Laboratory Standards Institute. Evaluation of the linearity of quantitative measurement procedures: A statistical approach; Approved guideline. CLSI document EP06-A. Wayne, PA: Clinical and Laboratory Standards Institute;2003.
10. Clinical and Laboratory Standards Institute. Measurement procedure comparison and bias estimation using patients samples; Approved guideline-Third editon. CLSI document EP09-A3. Wayne, PA: Clinical and Laboratory Standards Institute;2013.
11. Ricos C, Alvarez V, Cava F, Garcia-Lario JV, Hernandez A, Jimenez CV, et al. Desirable specifications for total error, imprecision, and bias, derived from intra- and inter-individual biologic variation. https://www.westgard.com/biodatabase1.htm (Updated on 2014).
12. White GH, Farrance I. AACB Uncertainty of Measurement Working Group. Uncertainty of measurement in quantitative medical testing: a laboratory implementation guide. Clin Biochem Rev. 2004; 25:S1–24.
13. Biswas SS, Bindra M, Jain V, Gokhale P. Evaluation of imprecision, bias and total error of clinical chemistry analysers. Indian J Clin Biochem. 2015; 30:104–108.
14. Delanghe JR, Cobbaert C, Harmoinen A, Jansen R, Laitinen P, Panteghini M. Focusing on the clinical impact of standardization of creatinine measurements: a report by the EFCC Working Group on Creatinine Standardization. Clin Chem Lab Med. 2011; 49:977–982.
15. Killeen AA, Ashwood ER, Ventura CB, Styer P. Recent trends in performance and current state of creatinine assays. Arch Pathol Lab Med. 2013; 137:496–502.
16. Statland BE. Clinical decision levels for lab tests. 2nd ed. Oradell, NJ: Medical Economics Books;1987. p. 72–73.
17. Jun SH, Song J, Song WH. Annual report on the external quality assessment scheme for clinical chemistry in Korea (2015). J Lab Med Qual Assur. 2016; 38:111–119.
18. Weber JA. Interferences in current methods for measurements of creatinine. Clin Chem. 1991; 37:695–700.
19. Greenberg N, Roberts WL, Bachmann LM, Wright EC, Dalton RN, Zakowski JJ, et al. Specificity characteristics of 7 commercial creatinine measurement procedures by enzymatic and Jaffe method principles. Clin Chem. 2012; 58:391–401.
20. O'Leary N, Pembroke A, Duggan PF. A simplified procedure for eliminating the negative interference of bilirubin in the Jaffé reaction for creatinine. Clin Chem. 1992; 38:1749–1751.
XML Download