BackgroundThe association between autoantibodies and the risk of type 1 diabetes mellitus (T1DM) is well established. However, there is still a lack of quantitative insight into the role of anti-zinc transporter 8 (anti-ZnT8) antibodies and their efficacy in T1DM diagnosis.ObjectiveTo conduct a systematic review and meta-analysis on the association between anti-ZnT8 autoantibodies and the risk of T1DM.MethodsRelevant studies were retrieved from the PubMed database and analyzed using a fixed or random-effects model.ResultsOut of 211 screened articles, 23 studies were selected and a total of 14,172 patients were included in the analysis. Our pooled analysis revealed that anti-ZnT8 autoantibody expression was significantly associated with an increased risk of T1DM development in both children and adults [OR 1.14 (95% CI: 1.12-1.16); P = 0.07].ConclusionOur systematic review and meta-analysis provides robust evidence supporting a significant association between anti-ZnT8 autoantibody positivity and an increased risk of T1DM development.