Neutrophil Gelatinase-Associated Lipocalin
Label Mnemonic: NGALU
Epic code: LAB8693
Downtime form: A-1a Doctor/Provider Orders - Pathology Core and Specialty Care Nursery
Chemistry
6240 RCP
356-3527
Specimen(s):
Random Urine
Collection Medium:
Clear top tube
Minimum:
Preferred Minimum: 3 mL random urine
Absolute Minimum: 1 mL random urine
Testing Schedule:
24 hrs/day, 7 days a week, including holidays.
Turn Around Time:
4 hours (upon receipt in laboratory)
Reference Range:
No established reference range for urine NGAL using this methodology.
Comments:
Neutrophil gelatinase-associated lipocalin (NGAL) is an emerging biomarker for earlier identification of acute kidney injury (AKI). Using similar methodology, a reference interval for urine NGAL in adults was determined to be <113 ng/mL. Age- and sex-specific ranges have not been established, but there is evidence that urine NGAL concentrations increase with age and are higher in females than in males.

Proposed NGAL cut-offs for diagnosing AKI vary considerably, but 150 ng/mL has been suggested to be optimal. However, elevations in urine NGAL may be caused by non-renal conditions, including infection, inflammation, and certain carcinomas.

This test has not been cleared or approved by the FDA. The University of Iowa Emory Warner Pathology Laboratories is regulated under CLIA as qualified to perform high-complexity testing. This test is used for clinical purposes. It should not be regarded as investigational or for research.

References:
Haase M, Bellomo R, Devarajan P, et al. "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: 1012-1024.

Cullen MR, Murray PT, Fitzgibbon MC. "Establishment of a reference interval for urinary neutrophil gelatinase-associated lipocalin." Ann Clin Biochem 2012; 49: 190-193.

Kift RL, Messenger MP, Wind TC, 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: 236-244.

Bennett MR, Ma Q, Ying J, Devarajan P, Brunner H. "Effects of age and gender on reference levels of biomarkers comprising the pediatric Renal Activity Index for Lupus Nephritis (p-RAIL)." Pediatr Rheumatol Online J 2017; 15: 74.
Test Limitations:
No significant interference (recovery within +/-15% of expected value) from urine protein concentration up to 800 mg/dL, 2+ bilirubin, 30,000 ng/mL myoglobin, phenazopyridine color interference and visible hemolysis.
Methodology:
Particle-enhanced Immunoturbidimetry
CPT Code:
83520
 
See Additional Information:
Urine Tests Requiring no Preservatives