Lab Med Online.  2011 Oct;1(4):179-183. 10.3343/lmo.2011.1.4.2.

Creatinine Determination by Nova CCX Analyzer Harmonized with the Roche Enzymatic Method for Early and Accurate Detection of Renal Dysfunction

Affiliations
  • 1Department of Laboratory Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. jeongho@yuhs.ac
  • 2Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
  • 3Department of Emergency Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.

Abstract

BACKGROUND
Early detection of underlying renal dysfunction among emergency patients is important, particularly before imaging studies using contrast media. The estimated glomerular filtration rate (eGFR) calculated from creatinine values is useful in situations requiring rapid evaluation and detection of renal impairment.
METHODS
We evaluated the concordance of eGFR determined using the whole blood creatinine test by Nova CCX (Cr-CCX WB; Nova Biomedical, USA) method and the serum creatinine test by Roche Integra 800 (Cr-RE Serum; Roche Diagnostics, Switzerland) enzymatic method, which is known to be traceable to the isotope dilution mass spectrometric (ID-MS) reference method.
RESULTS
Compared to Cr-RE Serum (x), Cr-CCX WB (y) showed good correlation but unacceptable total error and negative proportional bias (Deming regression, y=0.92x+0.02; r=0.98; n=61). However, when we adjusted the Cr-CCX WB values with a new slope and offset derived from the Deming regression analysis with Cr-RE Serum, the concordance rate improved from 0.77 to 0.93 (as measured by kappa statistics), and total errors became acceptable except at 1 level. When we used the ID-MS traceable eGFR formula, the Nova CCX demonstrated sufficient sensitivity (93.5%) and specificity (100%) for the detection of renal dysfunction (eGFR less than 60 mL/min/1.73 m2) in patients.
CONCLUSIONS
We concluded that if we adjusted the harmonizing factors of Nova CCX according to the ID-MS traceable method, then the Nova CCX might be a relatively accurate point-of-care creatinine analyzer for detecting renal dysfunction among patients undergoing urgent imaging studies with radiological contrast media.

Keyword

Creatinine; Estimated glomerular filtration rate; Nova CCX; Enzymatic

MeSH Terms

Bias (Epidemiology)
Contrast Media
Creatinine
Emergencies
Glomerular Filtration Rate
Humans
Sensitivity and Specificity
Contrast Media
Creatinine

Figure

  • Fig. 1 Deming fit of 61 creatinine values determined using Nova CCX and Roche enzymatic method after adjustment of harmonizing factors.

  • Fig. 2 Deming fit of eGFR values lower than 90 mL/min/1.73 m2 (n=43) determined Nova CCX and Roche enzymatic method after adjustment of harmonizing factors; correlation coefficient, r=0.98.


Reference

1. Levey AS, Coresh J, Greene T, Marsh J, Stevens LA, Kusek JW, et al. Expressing the Modification of Diet in Renal Disease Study equation for estimating glomerular filtration rate with standardized serum creatinine values. Clin Chem. 2007. 53:766–772.
Article
2. Barrett BJ, Parfrey PS. Clinical practice. Preventing nephropathy induced by contrast medium. N Engl J Med. 2006. 354:379–386.
3. Information for healthcare professionals: gadolinium-based contrast agents for magnetic resonance imaging (marketed as Magnevist, MultiHance, Omniscan, OptiMARK, ProHance). U.S. Food and Drug Administration. Updated in Dec 2010. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142884.htm.
4. Kim KH, Fonda JR, Lawler EV, Gagnon D, Kaufman JS. Change in use of gadolinium-enhanced magnetic resonance studies in kidney disease patients after US Food and Drug Administration warnings: a cross-sectional study of Veterans Affairs Health Care System data from 2005-2008. Am J Kidney Dis. 2010. 56:458–467.
Article
5. Information for safety letter for gadolinium based-contrast agents. Korea Food and Drug Administration. Updated in Sep 2010. http://www.kfda.go.kr/index.kfda?mid=394&pageNo=2&seq=8824&cmd=v.
6. Flegar-Mestrić Z, Perkov S. Comparability of point-of-care whole-blood electrolyte and substrate testing using a Stat Profile Critical Care Xpress analyzer and standard laboratory methods. Clin Chem Lab Med. 2006. 44:898–903.
Article
7. Korpi-Steiner NL, Williamson EE, Karon BS. Comparison of three whole blood creatinine methods for estimation of glomerular filtration rate before radiographic contrast administration. Am J Clin Pathol. 2009. 132:920–926.
Article
8. Schnabl KL, Bagherpoor S, Diker P, Cursio C, Dubois J, Yip PM. Evaluation of the analytical performance of the Nova StatSensor creatinine meter and reagent strip technology for whole blood testing. Clin Biochem. 2010. 43:1026–1029.
Article
9. Shephard M, Peake M, Corso O, Shephard A, Mazzachi B, Spaeth B, et al. Assessment of the Nova StatSensor whole blood point-of-care creatinine analyzer for the measurement of kidney function in screening for chronic kidney disease. Clin Chem Lab Med. 2010. 48:1113–1119.
Article
10. Vickery S, Stevens PE, Dalton RN, van Lente F, Lamb EJ. Does the ID-MS traceable MDRD equation work and is it suitable for use with compensated Jaffe and enzymatic creatinine assays? Nephrol Dial Transplant. 2006. 21:2439–2445.
Article
11. Clinical and Laboratory Standards Institute. Preparation and validation of commutable frozen human serum pools as secondary reference materials for cholesterol measurement procedures; approved guideline. CLSI document C37-A. 1999. Wayne, PA: Clinical and Laboratory Standards Institute.
12. Reference material institute for clinical chemistry standards (ReCCS). Updated in Mar 2005. http://www.reccs.or.jp/.
13. 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.
Article
14. 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.
Article
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