Background: Currently, there is a lack of prediction markers for diabetic nephropathy (DN) in patients with type 1 and type 2 diabetes mellitus (T1DM/T2DM). The aim of this systematic review and meta-analysis was to evaluate the value of a promising biomarker, neutrophil gelatinase-associated lipocalin (NGAL), in both serum and urine for the diagnosis of early DN in T1DM and T2DM patients with different stages of albuminuria. Methods: A comprehensive search was performed on PubMed by 2 reviewers until September 2018. Studies in which (a) the degree of DN was determined according to the urinary albumin/creatinine ratio and (b) NGAL was measured in healthy individuals and in diabetes patients with DN were included in the meta-analysis. For each study, a 2 × 2 contingency table was formulated. Sensitivity, specificity, and other estimates of accuracy were calculated using a bivariate random effects model. The hierarchical summary ROC method was used to pool data and to evaluate the area under the curve (AUC). The sources of heterogeneity were explored by subgroup analysis. Publication bias was assessed using the Deeks test. Results: The meta-analysis enrolled 22 studies involving 683 healthy individuals and 3249 patients with diabetes, of which 488 were T1DM and 2761 were T2DM patients. Overall, pooled sensitivity and specificity among the different settings analyzed ranged from 0.42 (95% CI, 0.22-0.66) to 1.00 (95% CI, 0.99-1.00) and 0.72 (95% CI, 0.62-0.80) to 0.98 (95% CI, 0.50-1.00) in T2DM patients, respectively. For T1DM patients, the corresponding estimates were 0.71 (95% CI, 0.59-0.81) to 0.89 (95% CI, 0.64-0.97) and 0.72 (95% CI, 0.62-0.80) to 0.79 (95% CI, 0.67-0.87). The AUC of NGAL for T2DM patients ranged from 0.69 (95% CI, 0.65-0.73) to 1.00 (95% CI, 0.99-1.00) in the different settings. Conclusion: The results of this meta-analysis suggest that NGAL in both serum and urine can be considered a valuable biomarker for early detection of DN in diabetes patients.

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