Stool Antigen Test for Helicobacter Pylori Infection in Adults : A Meta-analysis of Diagnostic Test Accuracy

The stool antigen test (SAT) is a convenient noninvasive option for the diagnosis of Helicobacter pylori ( H. pylori ) infection. However, despite having been previously evaluated, there is currently a lack of evidence regarding the comparative accuracy of conventional and rapid SATs utilizing monoclonal or polyclonal antibodies in adults. Here, we perform a thorough statistical synthesis to determine and compare the diagnostic accuracy of conventional and rapid SATs for the diagnosis of H. pylori infection in adults.

We conducted independent searches through July 25, 2023, for studies evaluating the accuracy of SAT against a reference standard. We assessed methodological quality using Quality Assessment of Diagnostic Accuracy Studies-2 and calculated overall accuracy measures using the bivariate random-effect model. We also conducted subgroup analyses based on model and assessment technique, and Spearman correlation analysis to investigate a possible threshold effect. We generated summary receiver operating characteristic curves to assess heterogeneity and evaluated publication bias.

Conventional SAT demonstrated superior sensitivity (92.19% vs 85.79%), specificity (92.93% vs 91.18%), likelihood ratios (LR+ 9.68 vs 8.16; LR- 0.10 vs 0.15), and area under the curve (0.958 vs 0.940) compared with rapid SAT. Notably, the diagnostic odds ratio for conventional SAT (114.70) significantly outperformed rapid SAT (diagnostic odds ratio: 57.72). Correlation analysis revealed no threshold effect and summary receiver operating characteristic curves showed consistent accuracy for both tests.

Our study establishes evidence of the superior diagnostic accuracy of conventional SATs over rapid SATs for detecting H. pylori infection in adults. Also, we provide valuable insights into the impact of using monoclonal or polyclonal antibodies and different assessment techniques on diagnostic accuracy measures.