Validation of plasma neutrophil gelatinase-associated lipocalin as a biomarker for diabetes-related acute kidney injury.

Objective: This retrospective study aimed to investigate the correlation between neutrophil gelatinase-associated lipocalin (NGAL) levels and the clinical progression and severity of diabetes-related acute kidney injury (AKI). The quantitative determination of NGAL in plasma on the Beckman Coulter AU480 analyzer was measured using the Bioporto NGAL Test^TM, a particle-enhanced turbidimetric immunoassay with hospitalized patients at an East Central Georgia Medical Center.

Methods: The clinical determination of plasma NGAL included a retrospective cohort study where 45 adult patients were selectively recruited. The selective criteria were patients with and without diabetes mellitus (DM) at risk for developing AKI admitted to the Medical Center between January and November 2023. All patients included in the study had pNGAL levels measured upon admission and up to 96 h post-admission. Receiver operating characteristics and likelihood ratio methods were used to determine optimal sensitivity, specificity, and cutoff value of pNGAL in AKI patients associated with and without DM.

Results: The intra-assay and interassay imprecision percent relative standard deviation was between 2.7% and 4.2%. pNGAL levels were higher for patients with AKI compared to non-AKI patients, regardless of DM status. The optimal cutoff value for pNGAL to predict AKI for patients with DM was 293 ng/mL, with a sensitivity of 80% and specificity of 87%. In a multivariate logistic regression model, pNGAL levels at 48 h post-admission were determined to be associated with diabetes-related AKI patients.

Conclusion: Plasma NGAL levels at 48 h are associated with patients with diabetes-related AKI. The specific cutoff values for AKI for early diagnosis and risk stratification and its association with comorbidities must be determined to improve patient outcomes.