Related Experiment Video
Updated: Oct 22, 2025

Estimation of Urinary Nanocrystals in Humans using Calcium Fluorophore Labeling and Nanoparticle Tracking Analysis
Published on: February 9, 2021
Urinary Biomarkers of Renal Injury KIM-1 and NGAL: Reference Intervals for Healthy Pediatric Population in Sri Lanka
P Mangala C S De Silva1, T D K S C Gunasekara1, S D Gunarathna1
1Department of Zoology, Faculty of Science, University of Ruhuna, Matara 81000, Sri Lanka.
Insights
This study establishes crucial reference intervals for kidney injury molecule-1 (KIM-1) and neutrophil gelatinase-associated lipocalin (NGAL) in Sri Lankan children. These findings aid in early detection of renal damage, particularly in areas affected by chronic kidney disease of unexplained etiology (CKDu).
Area of Science:
- Nephrology
- Biomarker Discovery
- Pediatric Research
Background:
- Emerging renal biomarkers like KIM-1 and NGAL show promise for diagnosing kidney injury.
- Limited global data exists on reference intervals for these biomarkers in pediatric populations.
- Sri Lanka faces a high burden of chronic kidney disease of unexplained etiology (CKDu), particularly in children.
Purpose of the Study:
- To determine reference intervals for urinary KIM-1 and NGAL in a pediatric population in Sri Lanka.
- To provide essential data for early renal damage screening in at-risk communities.
- To address the lack of pediatric reference data for emerging renal biomarkers.
Main Methods:
- Urine samples were collected from 909 children (10-18 years) without prior renal disease in Sri Lanka's dry zone.
- Urinary KIM-1 and NGAL concentrations were measured using ELISA and normalized to urinary creatinine.
- Reference intervals were derived using quantile regression, stratified by age and gender.
Main Results:
- Median reference intervals for urinary KIM-1 ranged from 0.081-0.426 ng/mg Cr (males) and 0.078-0.508 ng/mg Cr (females).
- Median reference intervals for urinary NGAL ranged from 2.966-4.850 ng/mg Cr (males) and 2.085-3.496 ng/mg Cr (females).
- Biomarker levels showed weak correlations with age, gender, ACR, and BMI.
Conclusions:
- This study provides the first pediatric reference intervals for KIM-1 and NGAL in Sri Lanka.
- These reference intervals are vital for facilitating early detection of renal damage.
- The findings are particularly relevant for screening in rural communities affected by CKDu.
Abstract:
Emerging renal biomarkers (e.g., kidney injury molecule-1 (KIM-1) and neutrophil gelatinase-associated lipocalin (NGAL)) are thought to be highly sensitive in diagnosing renal injury. However, global data on reference intervals for emerging biomarkers in younger populations are lacking. Here, we aimed to determine reference intervals for KIM-1 and NGAL across a pediatric population in Sri Lanka; a country significantly impacted by the emergence of chronic kidney disease of unexplained etiology (CKDu). Urine samples were collected from children (10-18 years) with no prior record of renal diseases from the dry climatic zone of Sri Lanka (N = 909). Urinary KIM-1 and NGAL concentrations were determined using the enzyme-linked immunosorbent assay (ELISA) and adjusted to urinary creatinine. Biomarker levels were stratified by age and gender, and reference intervals derived with quantile regression (2.5th, 50th, and 97.5th quantiles) were expressed at 95% CI. The range of median reference intervals for urinary KIM-1 and NGAL in children were 0.081-0.426 ng/mg Cr, 2.966-4.850 ng/mg Cr for males, and 0.0780-0.5076 ng/mg Cr, 2.0850-3.4960 ng/mg Cr for females, respectively. Renal biomarkers showed weak correlations with age, gender, ACR, and BMI. Our findings provide reference intervals to facilitate screening to detect early renal damage, especially in rural communities that are impacted by CKDu.
Related Concept Videos
Serum Studies: Renal Function Tests
Urine Studies I: Urinalysis
Pharmacokinetics in Pediatric Patients: Drug Excretion
Pharmacokinetics in Pediatric Patients: Drug Metabolism

