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A comparison of three commercial platforms for urinary NGAL in critically ill adults

  • Dinna N. Cruz , Grazia Maria Virzì , Alessandra Brocca , Claudio Ronco and Davide Giavarina EMAIL logo
Published/Copyright: June 18, 2015
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 54 Issue 2

Abstract

Background: Early biomarkers for acute kidney injury (AKI) diagnosis are needed since an increase in serum creatinine levels is a late marker. Neutrophil gelatinase-associated lipocalin (NGAL) is one of the most promising AKI biomarkers. Prior to routine clinical use, it is necessary to evaluate and validate a high-throughput commercially available method for NGAL detection. The aim of this study was to do an independent validation and comparison of the analytical performance of three different commercially available urine NGAL (uNGAL) assays.

Methods: Urine samples (n=110) were obtained from various patient groups with and without AKI. All urine samples were processed using Architect NGAL assay, Siemens Advia® 2400 NGAL test, and Siemens Dimension Vista® NGAL Test™, based on the three different platforms.

Results: Overall, there was good agreement among the three assays: Spearman’s rank correlation coefficient between Architect and Vista was 0.989 (95% confidence interval [CI], 0.983–0.993), between Architect and Advia, 0.962 (95% CI, 0.937–0.977), between Vista and Advia 2400, 0.975 (95% CI, 0.961–0.984). We observed a negative bias of Architect compared with the other assays: comparing Architect to Vista, the mean bias was –55.7 ng/mL (95% CI, –74.3 to –37.0 ng/mL); comparing Architect to Advia 2400, the mean bias was –40.9 ng/mL (95% CI, –56.4 to –25.4 ng/nL). The bias is proportional to the concentration of uNGAL and is more pronounced at higher levels, while irrelevant near the tested cutoff levels of 100 and 190 ng/mL. Comparing Vista and Advia 2400, the mean bias was 10.1 ng/mL (95% CI, 1.5–18.8 ng/mL). Intra-assay imprecision was generally acceptable across all assays; coefficient of variation ranged from 0.8% to 5.3%.

Conclusions: All three methods for uNGAL showed acceptable performance for the tested parameters and are comparable with each other at clinically relevant cutoffs. However, Architect yields lower results than the other two methods, with a bias more pronounced at higher uNGAL concentrations, suggesting additional standardization efforts will likely be necessary to better harmonize the uNGAL methods at various clinically relevant cutoffs.

Keywords: acute kidney injury (AKI); diagnosis; method comparison; neutrophil gelatinase-associated lipocalin (NGAL)
Corresponding author: Davide Giavarina, MD, Clinical Chemistry and Haematology Laboratory, St. Bortolo Hospital, Viale Mons. Rodolfi 37, 36100 Vicenza, Italy, Phone: +39 444 753254, Fax: +39 444 752501, E-mail:

References

1. Cruz DN, Goh CY, Haase-Fielitz A, Ronco C, Haase M. Early biomarkers of renal injury. Congest Heart Fail 2010;16(Suppl 1):S25–31.10.1111/j.1751-7133.2010.00163.xSearch in Google Scholar PubMed

2. Soni SS, Ronco C, Katz N, Cruz DN. Early diagnosis of acute kidney injury: the promise of novel biomarkers. Blood Purif 2009;28:165–74.10.1159/000227785Search in Google Scholar PubMed

3. Waikar SS, Betensky RA, Emerson SC, Bonventre JV. Imperfect gold standards for kidney injury biomarker evaluation. J Am Soc Nephrol 2012;23:13–21.10.1681/ASN.2010111124Search in Google Scholar PubMed PubMed Central

4. Devarajan P. Neutrophil gelatinase-associated lipocalin: a promising biomarker for human acute kidney injury. Biomark Med 2010;4:265–80.10.2217/bmm.10.12Search in Google Scholar PubMed PubMed Central

5. Ricci Z, Cruz D, Ronco C. The RIFLE criteria and mortality in acute kidney injury: a systematic review. Kidney Int 2008;73:538–46.10.1038/sj.ki.5002743Search in Google Scholar PubMed

6. Siew ED, Ware LB, Ikizler TA. Biological markers of acute kidney injury. J Am Soc Nephrol 2011;22:810–20.10.1681/ASN.2010080796Search in Google Scholar PubMed

7. Soni SS, Cruz D, Bobek I, Chionh CY, Nalesso F, Lentini P, et al. NGAL: a biomarker of acute kidney injury and other systemic conditions. Int Urol Nephrol 2010;42:141–50.10.1007/s11255-009-9608-zSearch in Google Scholar PubMed

8. Ronco C, Cruz D, Noland BW. Neutrophil gelatinase-associated lipocalin curve and neutrophil gelatinase-associated lipocalin extended-range assay: a new biomarker approach in the early diagnosis of acute kidney injury and cardio-renal syndrome. Semin Nephrol 2012;32:121–8.10.1016/j.semnephrol.2011.11.015Search in Google Scholar PubMed

9. Makris K, Rizos D, Kafkas N, Haliassos A. Neurophil gelatinase-associated lipocalin as a new biomarker in laboratory medicine. Clin Chem Lab Med 2012;50:1519–32.10.1515/cclm-2012-0227Search in Google Scholar PubMed

10. Haase M, Bellomo R, Devarajan P, Schlattmann P, Haase-Fielitz A. Accuracy of neutrophil gelatinase-associated lipocalin (NGAL) in diagnosis and prognosis in acute kidney injury: a systematic review and meta-analysis. Am J Kidney Dis 2009;54:1012–24.10.1053/j.ajkd.2009.07.020Search in Google Scholar PubMed

11. Di Grande A, Giuffrida C, Carpinteri G, Narbone G, Pirrone G, Di Mauro A, et al. Neutrophil gelatinase-associated lipocalin: a novel biomarker for the early diagnosis of acute kidney injury in the emergency department. Eur Rev Med Pharmacol Sci 2009;13:197–200.Search in Google Scholar

12. de Geus HR, Bakker J, Lesaffre EM, le Noble JL. Neutrophil gelatinase-associated lipocalin at ICU admission predicts for acute kidney injury in adult patients. Am J Respir Crit Care Med 2011;183:907–14.10.1164/rccm.200908-1214OCSearch in Google Scholar PubMed

13. Cruz DN, de Cal M, Garzotto F, Perazella MA, Lentini P, Corradi V, et al. Plasma neutrophil gelatinase-associated lipocalin is an early biomarker for acute kidney injury in an adult ICU population. Intensive Care Med 2010;36:444–51.10.1007/s00134-009-1711-1Search in Google Scholar PubMed PubMed Central

14. Clerico A, Galli C, Fortunato A, Ronco C. Neutrophil gelatinase-associated lipocalin (NGAL) as biomarker of acute kidney injury: a review of the laboratory characteristics and clinical evidences. Clin Chem Lab Med 2012;50:1505–17.10.1515/cclm-2011-0814Search in Google Scholar PubMed

15. Cruz DN, Bagshaw SM, Maisel A, Lewington A, Thadhani R, Chakravarthi R, et al. Use of biomarkers to assess prognosis and guide management of patients with acute kidney injury. Contrib Nephrol 2013;182:45–64.10.1159/000349965Search in Google Scholar PubMed

16. Murray PT, Mehta RL, Shaw A, Ronco C, Endre Z, Kellum JA, et al. Potential use of biomarkers in acute kidney injury: report and summary of recommendations from the 10th Acute Dialysis Quality Initiative consensus conference. Kidney Int 2014;85:513–21.10.1038/ki.2013.374Search in Google Scholar PubMed PubMed Central

17. Stejskal D, Karpisek M, Humenanska V, Hanulova Z, Stejskal P, Kusnierova P, et al. Lipocalin-2: development, analytical characterization, and clinical testing of a new ELISA. Horm Metab Res 2008;40:381–5.10.1055/s-2008-1062746Search in Google Scholar PubMed

18. Pedersen KR, Ravn HB, Hjortdal VE, Norregaard R, Povlsen JV. Neutrophil gelatinase-associated lipocalin (NGAL): validation of commercially available ELISA. Scand J Clin Lab Invest 2010;70:374–82.10.3109/00365513.2010.486868Search in Google Scholar PubMed

19. Grenier FC, Ali S, Syed H, Workman R, Martens F, Liao M, et al. Evaluation of the ARCHITECT urine NGAL assay: assay performance, specimen handling requirements and biological variability. Clin Biochem 2010;43:615–20.10.1016/j.clinbiochem.2009.12.008Search in Google Scholar PubMed

20. Kift RL, Messenger MP, Wind TC, Hepburn S, Wilson M, Thompson D, et al. A comparison of the analytical performance of five commercially available assays for neutrophil gelatinase-associated lipocalin using urine. Ann Clin Biochem 2013;50(Pt 3):236–44.10.1258/acb.2012.012117Search in Google Scholar PubMed

21. Lippi G, Aloe R, Storelli A, Cervellin G, Trenti T. Evaluation of NGAL Test, a fully-automated neutrophil gelatinase-associated lipocalin (NGAL) immunoassay on Beckman Coulter AU 5822. Clin Chem Lab Med 2012;50:1581–4.10.1515/cclm.2011.839Search in Google Scholar PubMed

22. Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group. KDIGO clinical practice guideline for acute kidney injury. Kidney Int 2012;(Suppl):1–138.Search in Google Scholar

23. Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, et al. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med 2003;31: 1250–6.10.1097/01.CCM.0000050454.01978.3BSearch in Google Scholar PubMed

24. NCCLS: evaluation of precision performance of quantitative measurement methods; approved guideline, 2nd ed. NCCLS document EP5-A2 2004;24(25).Search in Google Scholar

25. Chesher D. Evaluating assay precision. Clin Biochem Rev 2008;29(Suppl 1):S23–6.Search in Google Scholar

26. Nickolas TL, Schmidt-Ott KM, Canetta P, Forster C, Singer E, Sise M, et al. Diagnostic and prognostic stratification in the emergency department using urinary biomarkers of nephron damage: a multicenter prospective cohort study. J Am Coll Cardiol 2012;59:246–55.10.1016/j.jacc.2011.10.854Search in Google Scholar PubMed PubMed Central

27. McCullough PA, Shaw AD, Haase M, Bouchard J, Waikar SS, Siew ED, et al. Diagnosis of acute kidney injury using functional and injury biomarkers: workgroup statements from the tenth Acute Dialysis Quality Initiative Consensus Conference. Contrib Nephrol 2013;182:13–29.10.1159/000349963Search in Google Scholar PubMed

28. Bennett M, Dent CL, Ma Q, Dastrala S, Grenier F, Workman R, et al. Urine NGAL predicts severity of acute kidney injury after cardiac surgery: a prospective study. Clin J Am Soc Nephrol 2008;3:665–73.10.2215/CJN.04010907Search in Google Scholar PubMed PubMed Central

29. Vanmassenhove J, Vanholder R, Nagler E, Van Biesen W. Urinary and serum biomarkers for the diagnosis of acute kidney injury: an in-depth review of the literature. Nephrol Dial Transplant 2013;28:254–73.10.1093/ndt/gfs380Search in Google Scholar PubMed

30. Cavalier E, Bekaert AC, Carlisi A, Legrand D, Krzesinski JM, Delanaye P. Neutrophil gelatinase-associated lipocalin (NGAL) determined in urine with the Abbott Architect or in plasma with the Biosite Triage? The laboratory’s point of view. Clin Chem Lab Med 2011;49:339–41.10.1515/CCLM.2011.044Search in Google Scholar PubMed

31. Waikar SS, Sabbisetti VS, Bonventre JV. Normalization of urinary biomarkers to creatinine during changes in glomerular filtration rate. Kidney Int 2010;78:486–94.10.1038/ki.2010.165Search in Google Scholar PubMed PubMed Central

32. Tonomura Y, Uehara T, Yamamoto E, Torii M, Matsubara M. Decrease in urinary creatinine in acute kidney injury influences diagnostic value of urinary biomarker-to-creatinine ratio in rats. Toxicology 2011;290:241–8.10.1016/j.tox.2011.10.001Search in Google Scholar PubMed

Received: 2015-5-15
Accepted: 2015-5-27
Published Online: 2015-6-18
Published in Print: 2016-2-1

©2016 by De Gruyter

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https://doi.org/10.1515/cclm-2015-0464
Keywords for this article
acute kidney injury (AKI); diagnosis; method comparison; neutrophil gelatinase-associated lipocalin (NGAL)

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Total error vs. measurement uncertainty: the match continues
  4. Review
  5. Application of fatty acid and lipid measurements in neuropsychiatry
  6. Mini Review
  7. The Janus faces of acquired angioedema: C1-inhibitor deficiency, lymphoproliferation and autoimmunity
  8. Opinion Papers
  9. How to report results of prothrombin and activated partial thromboplastin times
  10. Useful measures and models for analytical quality management in medical laboratories
  11. Total error vs. measurement uncertainty: revolution or evolution?
  12. Genetics and Molecular Diagnostics
  13. Rapid detection of Mmalton α1-antitrypsin deficiency allele by real-time PCR and melting curves in whole blood, serum and dried blood spot samples
  14. General Clinical Chemistry and Laboratory Medicine
  15. Diagnostic and clinical significance of Crohn’s disease-specific pancreatic anti-GP2 and anti-CUZD1 antibodies
  16. Immunoassays for the detection of IgA antibodies to tissue transglutaminase: significance of multiples of the upper limit of normal and inter-assay correlations
  17. Effects of biobanking conditions on six antibiotic substances in human serum assessed by a novel evaluation protocol
  18. Haematology and Coagulation
  19. Measurement of dabigatran, rivaroxaban and apixaban in samples of plasma, serum and urine, under real life conditions. An international study
  20. Reference Values and Biological Variations
  21. Upper reference limits for cerebrospinal fluid total protein and albumin quotient based on a large cohort of control patients: implications for increased clinical specificity
  22. Reference intervals for bone turnover markers in Spanish premenopausal women
  23. Cancer Diagnostics
  24. Citrulline as a biomarker of gastrointestinal toxicity in patients with rectal carcinoma treated with chemoradiation
  25. mRNA overexpression of kallikrein-related peptidase 14 (KLK14) is an independent predictor of poor overall survival in chronic lymphocytic leukemia patients
  26. Cardiovascular Diseases
  27. TBX20 loss-of-function mutation associated with familial dilated cardiomyopathy
  28. Cardiac troponin I release after a basketball match in elite, amateur and junior players
  29. The role of timely measurement of galectin-3, NT-proBNP, cystatin C and hsTnT in predicting prognosis and heart function after heart transplantation
  30. Infectious Diseases
  31. Neutrophil CD64 combined with PCT, CRP and WBC improves the sensitivity for the early diagnosis of neonatal sepsis
  32. A comparison of three commercial platforms for urinary NGAL in critically ill adults
  33. Diabetes
  34. Liquid citrate acidification introduces significant glucose bias and leads to misclassification of patients with diabetes
  35. Letter to the Editors
  36. A rare and unstable hemoglobin variant, Hb M Dothan β 25/26 (-GTG), detected by the anomalous cytogram on Sysmex XE-2100
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  38. Falsely elevated ferritin in patients with a high concentration of rheumatoid factor
  39. Susceptibility of commonly used ferritin assays to the classic hook effect
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  41. Performance evaluation of low platelet count and platelet clumps detection on Mindray BC-6800 hematology analyzer
  42. Fetal sex discordance between sequencing-based and real-time PCR non-invasive prenatal test due to a vanishing twin
  43. Total HIV-1 DNA detection and quantification in peripheral blood by COBAS®AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0
  44. A replacement for the testosterone “sex gap”
  45. Added value of indirect immunofluorescence intensity of automated antinuclear antibody testing in a secondary hospital setting
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