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Abstract: SA-PO107

Determination of Urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) Reference Intervals for Healthy Adult and Pediatric Individuals

Session Information

Category: Acute Kidney Injury

  • 102 AKI: Clinical, Outcomes, and Trials


  • Pedersen, Ronnie O., Bioporto A/S, Hellerup, Gentofte, Denmark
  • Broyles, Dennis, L3 Healthcare Solutions LLC, San Diego, California, United States
  • Bird, Christopher, Bioporto A/S, Hellerup, Gentofte, Denmark
  • Klause, Ursula, Bioporto A/S, Hellerup, Gentofte, Denmark

Neutrophil gelatinase-associated lipocalin (NGAL) is a 25kDa protein implicated in multiple biological processes, including attenuation of apoptosis and differentiation of renal tubule epithelial cells and nephrons. NGAL is also produced and secreted by injured kidney tubule epithelial cells. As such, NGAL can serve as an early urinary biomarker for acute kidney injury (AKI). This multi-site, cross-sectional study aimed to establish reference intervals for urinary NGAL (uNGAL) in healthy pediatric and adult populations using a particle-enhanced turbidimetric assay.


Apparently healthy individuals, aged >3 months, were eligible for this study. Subjects with urinary tract infections, acute kidney injury (AKI) or a history of AKI, stage 4 or 5 chronic kidney disease (CKD), known congenital anomalies of the kidney and urinary tract, known urothelial, urological, or kidney malignancies were excluded from the study. Subjects with uncorrected congenital heart disease, having undergone solid organ or bone marrow transplantation, receiving renal replacement therapy, and having undergone surgery (urologic, nephrectomy, or correction of congenital heart disease) were also excluded. Six hundred eighty-eight (688) subjects were screened, 677 were eligible, and 629 (91.4%) were considered evaluable. Urine samples were collected and tested for NGAL and UTI.


The following table describes the NGAL summary statistics and upper 95th reference intervals by age and gender.


These data demonstrate the normal urine NGAL reference intervals in apparently healthy pediatric and adult populations.


  • Commercial Support – BioPorto A/S