Urinary Neutrophil Gelatinase-Associated Lipocalin for the Diagnosis of Urinary Tract Infections.

OBJECTIVES: To determine the accuracy of the novel biomarker urinary neutrophil gelatinase-associated lipocalin (uNGAL) to diagnose urinary tract infections (UTIs) in febrile infants and young children.

METHODS: Prospective cross-sectional study of febrile infants <3 months ( ≥ 38.0°C) and children 3 to 24 months (≥ 39.0°C) evaluated for UTIs. uNGAL levels, urinalysis, Gram-stain and culture were obtained. UTI was defined by colony counts.

RESULTS: Of 260 patients, 35 (13.5%) had UTIs. Median uNGAL levels were 215.1 ng/mL (interquartile range: 100.3-917.8) and 4.4 ng/mL (interquartile range: 1.6-11.8) in the groups diagnosed with and without UTIs, respectively. The area under the receiver-operating characteristic curve for uNGAL was 0.978 (95% confidence interval [CI]: 0.948-1.000). At a threshold uNGAL level of 39.1 ng/mL, sensitivity was 97.1% (95% CI: 83.4-99.9) and specificity was 95.6% (95% CI: 91.7-97.7). uNGAL had higher sensitivity than the combination of leukocyte esterase (in trace or greater amounts) or nitrite (+) (97.1%, 95% CI: 83.4-99.9 vs 74.3%, 95% CI: 56.4-86.9), with similar specificity (95.6%, 95% CI: 91.7-97.7 vs 97.3%, 95% CI: 94.0-98.9). uNGAL had higher sensitivity than Gram-stain (97.1%, 95% CI: 83.4-99.9 vs 74.3%, 95%: CI: 56.4-86.9), with similar specificity (95.6%, 95% CI: 91.7-97.7 vs 100.0%, 95% CI: 97.9-100.0).

CONCLUSIONS: uNGAL has substantial accuracy to identify those with and without UTIs in infants and young children. Further studies will need to confirm our findings and determine if uNGAL is a more cost-effective test than standard screening tests.