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Sensitivity and Specificity of a Single Emergency Department Measurement of Urinary Neutrophil Gelatinase–Associated Lipocalin for Diagnosing Acute Kidney Injury

Thomas L. Nickolas, MD, MS; Matthew J. O'Rourke, BS; Jun Yang, MD, PhD; Meghan E. Sise, BS; Pietro A. Canetta, MD; Nicholas Barasch, BS; Charles Buchen; Faris Khan, MD; Kiyoshi Mori, MD, PhD; James Giglio, MD; Prasad Devarajan, MD; and Jonathan Barasch, MD, PhD
[+] Article and Author Information

From Columbia University, New York, New York; Kyoto University Graduate School of Medicine, Kyoto, Japan; and Cincinnati Children's Hospital, University of Cincinnati, Cincinnati, Ohio.


Note: Drs. Nickolas and Yang and Mr. O'Rourke contributed equally to this work.

Disclaimer: The contents of this article are solely the responsibility of the authors and do not necessarily represent the official view of the National Center for Research Resources or the NIH.

Acknowledgment: The authors thank Dean Lee Goldman, Columbia University, for critical review. This work would not have been possible without the generous support of the Emerald Foundation.

Grant Support: From the Emerald Foundation; the National Institutes of Health (grants DK55388, DK58872, and DK73462); the March of Dimes; the Doris Duke Foundation; the National Center for Research Resources, a component of the NIH (grant UL1 RR024156); and NIH Roadmap for Medical Research.

Potential Financial Conflicts of Interest:Honoraria: P. Devarajan (Biosite, Abbott). Grants pending: P. Devarajan (Abbott, Biosite). Patents pending: T.L. Nickolas (NGAL for diagnosis of chronic renal failure), K. Mori (NGAL for diagnosis of chronic renal failure), P. Devarajan (NGAL for diagnosis of acute renal failure and NGAL for diagnosis of chronic renal failure), J. Barasch (NGAL for diagnosis of acute renal failure and NGAL for diagnosis of chronic renal failure). Cincinnati Children's Hospital Medical Center and Columbia University have received licensing fees from Biosite and Abbott Diagnostics for technology to use NGAL as a biomarker of acute renal failure.

Reproducible Research Statement:Study protocol, statistical code, and data set: Available by written agreement from Dr. Nickolas (e-mail, tln2001@columbia.edu).

Requests for Single Reprints: Thomas L. Nickolas, MD, MS, Columbia University, PH 4 Stem, Room 124, 622 West 168th Street, New York, NY 10032; e-mail, tln2001@columbia.edu.

Current Author Addresses: Drs. Nickolas, Canetta, Khan, and J. Barasch; Ms. Sise; Mr. Buchen; and Mr. N. Barasch: Department of Medicine, Columbia University, 630 West 168th Street, New York, NY 10032.

Mr. O'Rourke: College of Physicians and Surgeons, Columbia University Medical School, 630 West 168th Street, New York, NY 10032.

Dr. Yang: Saint Luke's Roosevelt Hospital, Columbia University, 1000 Tenth Avenue, New York, NY 10019.

Dr. Mori: Department of Medicine and Clinical Science, Kyoto University Graduate School of Medicine, 54 Shogoin Kawahara-cho, Sakyo-ku hio 45229-3039, Kyoto 606-8507, Japan.

Dr. Giglio: Department of Emergency Medicine, Columbia University, 630 West 168th Street, New York, NY 10032.

Dr. Devarajan: Section of Nephrology, Cincinnati Children's Hospital, University of Cincinnati, 3333 Burnet Avenue, Cincinnati, OH 45229-3039.

Author Contributions: Conception and design: T.L. Nickolas, M.J. O'Rourke, J. Yang, N. Barasch, K. Mori, J. Giglio, P. Devarajan, J. Barasch.

Analysis and interpretation of the data: T.L. Nickolas, M.J. O'Rourke, M.E. Sise, P.A. Canetta, N. Barasch, C. Buchen, F. Khan, K. Mori, J. Giglio, P. Devarajan, J. Barasch.

Drafting of the article: T.L. Nickolas, M.J. O'Rourke, M.E. Sise, P.A. Canetta, N. Barasch, C. Buchen, K. Mori, J. Giglio, P. Devarajan, J. Barasch.

Critical revision of the article for important intellectual content: T.L. Nickolas, M.J. O'Rourke, M.E. Sise, P.A. Canetta, K. Mori, J. Giglio, P. Devarajan, J. Barasch.

Final approval of the article: T.L. Nickolas, M.J. O'Rourke, J. Yang, M.E. Sise, P.A. Canetta, N. Barasch, C. Buchen, F. Khan, K. Mori, J. Giglio, P. Devarajan, J. Barasch.

Provision of study materials or patients: T.L. Nickolas, M.J. O'Rourke, M.E. Sise, N. Barasch.

Statistical expertise: T.L. Nickolas, K. Mori.

Obtaining of funding: T.L. Nickolas, J. Barasch.

Administrative, technical, or logistic support: T.L. Nickolas, M.J. O'Rourke, M.E. Sise, N. Barasch, C. Buchen, F. Khan, K. Mori, J. Giglio, J. Barasch.

Collection and assembly of data: T.L. Nickolas, M.J. O'Rourke, M.E. Sise, N. Barasch, C. Buchen, F. Khan.


Ann Intern Med. 2008;148(11):810-819. doi:10.7326/0003-4819-148-11-200806030-00003
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This study was approved by the Columbia University Medical Center Institutional Review Board, and informed consent was obtained before enrollment. We recruited consecutive patients 18 years and older who visited the Columbia University Medical Center emergency department between 6 a.m. and 12 a.m. from March to August 2007. We obtained the first sample of donated urine and blood. We excluded 17 patients who were receiving hemodialysis and 230 patients without subsequent creatinine measurements from further analysis (Figure 1).

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Figures

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Figure 2.
Box plots of urinary neutrophil gelatinase–associated lipocalin (NGAL) and serum creatinine levels, by diagnostic group.

Top. Patients with acute kidney injury had markedly elevated mean urinary NGAL levels compared with patients who had other forms of kidney dysfunction. Little overlap was present, except in 3 patients with chronic kidney disease and 1 patient with prerenal azotemia who had high urinary NGAL levels. Bottom. Patients with acute kidney injury had significantly elevated mean serum creatinine levels compared with patients who had other forms of kidney dysfunction, but values overlapped among the different categories of kidney function. To convert mg/dL to µmol/L, multiply by 88.402.

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Figure 3.
Kidney injury biomarkers versus clinical outcome.

Measurements are normalized per gram of creatinine. Bars show the proportion of patients with biomarker levels above the selected cutoffs and clinical outcome. The total number of patients whose levels were above the cutoff was 66 for creatinine, 31 for neutrophil gelatinase–associated lipocalin (NGAL), 133 for N-acetyl-β-d-glucosaminidase (NAG), 143 for α1-microglobulin (A1M), and 294 for α1-acid glycoprotein (AAG). *P < 0.001 compared with NGAL.

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