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Validation of an assay for NGAL in a pediatric population
Nazmin Bithi1,2, Ridwan B Ibrahim1,2, Estella L Tam2
1Department of Pathology and Immunology, Baylor College of Medicine, Houston, TX, USA.
Background And Objectives:
Acute kidney injury (AKI) poses a serious clinical challenge, particularly in high-risk environments, due to its association with increased morbidity and mortality. Traditional diagnostic markers, such as serum creatinine, often detect AKI only after significant kidney damage has occurred, limiting opportunities for early intervention. Neutrophil gelatinase-associated lipocalin (NGAL) has emerged as a promising early biomarker due to its rapid upregulation following kidney ischemia. NGAL supports renal recovery by reducing toxicity and promoting tubular regeneration via heme oxygenase-1 activity. This study aimed to validate the BioPorto ProNephro AKI™ turbidimetric immunoassay for urinary NGAL on the Ortho Vitros XT7600 analyzer and evaluate its clinical utility in detecting early-stage AKI.
Design And Methods:
Assay performance was evaluated in accordance with CLSI guidelines, assessing precision, linearity, method agreement, specificity, and reference range. Method comparison involved 20 urine samples, while reference range verification used 57 pediatric samples. A clinical validation study included 21 pediatric CRRT patient samples to assess real-world diagnostic performance.
Results:
The assay demonstrated strong precision (intra-assay CV: 1.3-1.8 %; inter-assay CV: 1.8-2.7 %) and excellent linearity (18-1140 ng/mL; extended to 15,000 ng/mL with dilution). High correlation (r = 0.9836) was observed in method comparison. Specificity tests showed minimal interference. Clinical validation yielded 76.19 % sensitivity and 100 % specificity for AKI detection.
Conclusions:
The BioPorto ProNephro AKI™ assay on the Ortho Vitros XT7600 shows high sensitivity and specificity for urinary NGAL detection in pediatric patients, enabling early AKI identification, timely intervention, and potentially improved clinical outcomes through enhanced diagnostic performance.
