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BACKGROUND: Numerous serologic tests are available for the diagnosis of H. pylori infection in children. Common designs of antibody-based detection tests are ELISA and Western Blot (WB). For developing countries with limited laboratory resources and access, ELISA would be the preferred method because of its simplicity, lower cost and speed. Although in adults ELISA has proven to be highly accurate in diagnosing H. pylori infection; in children, it has shown variable accuracy. METHODS/FINDINGS: We conducted a systematic review and meta-analysis to assess the accuracy of antibody-based detection tests for the diagnosis of H. pylori infection in children. Selection criteria included participation of at least 30 children and the use of a gold standard for H. pylori diagnosis. In a comprehensive search we identified 68 studies. Subgroup analyses were carried out by technique, immunoglobulin class, and source of test (commercial and in-house). The results demonstrated: 1) WB tests showed high overall performance, sensitivity 91.3% (95% CI, 88.9-93.3), specificity 89% (95% CI, 85.7-91.9), LR+ 8.2 (95% CI, 5.1-13.3), LR- 0.06 (95% CI, 0.02-0.16), DOR 158.8 (95% CI, 57.8-435.8); 2) ELISA-IgG assays showed low sensitivity 79.2% (95% CI, 77.3-81.0) and high specificity (92.4%, 95% CI, 91.6-93.3); 3) ELISA commercial tests varied widely in performance (test for heterogeneity p |
