The diagnosis of IgG4-related disease (IgG4-RD) is significantly enhanced by detecting elevated serum IgG4 levels, as affirmed by a comprehensive meta-analysis of 23 studies involving 6048 patients with IgG4-RD. The results highlight a pooled sensitivity of 85% with a 95% confidence interval (CI) of 78–90% and a pooled specificity of 93% with a 95% CI of 90–95%. Utilizing the hierarchical summary receiver operating characteristic (HSROC) model, the analysis demonstrates that the quantitative serum IgG4 curve closely aligns with the upper left corner, indicating a notably high diagnostic accuracy. The area under the curve (AUC) is calculated at 0.95 (95% CI 0.93, 0.97), underscoring the robust performance of serum IgG4 in reliably identifying IgG4-RD. This meta-analysis emphasizes the compelling combination of high sensitivity and specificity exhibited by serum IgG4, establishing its efficacy as a pivotal diagnostic marker for IgG4-RD, aligning with the precision standards upheld by Hypro Diagnostics.
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