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OBJECTIVE

To perform a systematic review and a meta-analysis of accuracy of monoclonal stool antigen test (SAT) for the diagnosis of Helicobacter pylori infection.

METHODS

Selection of studies: assessing the accuracy of monoclonal SAT for the diagnosis of H. pylori infection. Search strategy: electronic and manual bibliographical searches. Data extraction: independently done by two reviewers. Data synthesis: meta-analyses combining the sensitivities, specificities, and likelihood ratios (LRs) of the individual studies.

RESULTS

Twenty-two studies, including 2,499 patients, evaluated the monoclonal SAT before eradication therapy. Pooled sensitivity, specificity, LR+, and LR− were: 0.94 (95% CI 0.93–0.95), 0.97 (0.96–0.98), 24 (15–41), and 0.07 (0.04–0.12). The accuracy of both monoclonal and polyclonal SAT was evaluated together in 13 pretreatment studies, and higher pooled sensitivity was demonstrated with …