Comparison of a monoclonal with a polyclonal antibody-based enzyme immunoassay stool test in diagnosing Helicobacter pylori infection after eradication therapy

Background Recently, a novel Helicobacter pylori stool antigen test (Testmate pylori antigen EIA) using monoclonal antibodies against H. pylori catalase has been developed commercially. This study assessed the diagnostic usefulness of the stool antigen test compared with a polyclonal enzyme immunoassay (HpSA test) after H. pylori eradication. Methods A total of 150 patients with H. pylori infection were treated by triple therapy with PPI and amoxicillin with either clarithromycin or metronidazole. H. pylori stool antigen was tested 4 and 8 weeks after eradication. The outcome of H. pylori eradication was assessed by urea breath test (UBT) 8 weeks after the end of therapy. Discordant results were followed by endoscopic examination. Results Of 150 patients enrolled, H. pylori status was negative in 122 cases and positive in 28 cases, assessed by the C-13-UBT. On the other hand, the monoclonal stool antigen test results were negative in 126 cases and positive in 24. The polyclonal stool test results were negative in 126 cases and positive in 22. The overall sensitivity and specificity of the monoclonal stool antigen test were 91.6% (95% CI 85.9-97.3%) and 98.4% (95% CI 97.3-99.5%). The overall sensitivity and specificity of the polyclonal stool antigen test were 87.0% (95% CI 86.9-94.0%) and 97.5% (95% CI 96.1-98.9%). Conclusion The new stool antigen test using monoclonal antibody is useful for the diagnosis of H. pylori eradication 4 weeks after the end of treatment.