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Abstract: TH-PO512

GUIDANCE: Primary Results of a Prospective, Observational Clinical Study Evaluating the Performance of Urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) in the Risk Assessment of AKI in Pediatric ICU Patients

Session Information

  • Pediatric Nephrology - I
    November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Pediatric Nephrology

  • 1900 Pediatric Nephrology


  • Goldstein, Stuart, Cincinnati Children’s Hospital, Cincinnati, Ohio, United States
  • Menon, Shina, Seattle Children’s Hospital, Seattle, Washington, United States
  • Gist, Katja M., Children’s Hospital of Colorado, Aurora, Colorado, United States
  • Soohoo, Megan, Children’s Hospital of Colorado, Aurora, Colorado, United States
  • Afonso, Natasha, Texas Children’s Hospital, Houston, Texas, United States
  • Kwiatkowski, David M., Lucile Packard Children's Hospital School, Palo Alto, California, United States
  • Mastropietro, Christopher W., Riley Hospital for Children at Indiana University Health, Indianapolis, Indiana, United States
  • Askenazi, David J., Children’s of Alabama, University of Alabama at Birmingham, Birmingham, Alabama, United States
  • Beng, Hostensia M., East Carolina University Brody School of Medicine, Greenville, North Carolina, United States
  • Kizilbash, Sarah J., University of Minnesota Children's Hospital, Minneapolis, Minnesota, United States
  • Basalely, Abby Miriam, Cohen Children's Medical Center, Queens, New York, United States
  • Traum, Avi, Boston Children's Hospital, Boston, Massachusetts, United States
  • Fitzgerald, Julie C., The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

Group or Team Name

  • The GUIDANCE Investigators.

Acute kidney injury (AKI) has been associated with prolonged hospital stays, future progression to chronic kidney disease, and a 25-80% risk of in-hospital death in critically ill patients. Our ability to treat this condition is lacking, partially due to our inability to detect AKI early. We sought to validate the clinical cut-off value for neutrophil gelatinase-associated lipocalin (NGAL) in pediatric patients. Here, we report the clinical performance of NGAL as a risk assessment marker for AKI in GUIDANCE, a validation study completed in support of an FDA submission.


Children (aged > 90d to 22 yr) admitted to an intensive care unit (ICU) with a urine sample collected within 24 hours of admission were eligible. Eligible patients must have had either mechanical ventilation, vasoactive medication administration, solid organ or bone marrow transplantation, OR hypotension within 24 hours of admission. Urine NGAL was measured using a particle-enhanced, turbidimetric, NGAL assay. Serum creatinine (SCr) was measured on days 1, 2, and 3 to determine stage 2 or 3 SCr-AKI per KDIGO guidelines. Independent adjudication by three clinical experts assessed for AKI within 48-72 hours using SCr measurements and clinical information but did not have access to NGAL results. NGAL positivity was defined as a urine concentration >125 ng/mL based on a prior derivation study.


Six hundred sixty patients were screened, and 514 were evaluable per the study protocol. Forty-seven patients (9.1%) developed stage 2 or 3 AKI; 36 of these patients were NGAL-positive. The sensitivity, specificity, negative predictive value, and positive predictive value for the NGAL test >125 ng/mL was 76.6% (36/47), 86.8% (406/468), 97.6% (406/416), 36.7% (36/98), respectively. The diagnostic performance of NGAL as demonstrated by an area under the ROC was 0.86 (95%CI, 0.80-0.92).


These data demonstrate that a particle-enhanced, turbidimetric, NGAL assay performs well early in ICU course to aid in risk assessment for stage 2 or 3 AKI in critically ill children.


  • Commercial Support – BioPorto Diagnostics