Usefulness of a novel enzyme immunoassay for the detection of Helicobacter pylori in feces.

Background: In this study we assessed the reliability of a newly developed enzyme immunoassay (HpSA) kit for detecting Helicobacter pylori antigen in stool. Methods: This study included 309 patients, 147 of whom were defined as positive and 162 as negative by the 13C-urea breath test, rapid urease test, and pathologic findings. From these patients fresh stool specimens were collected for HpSA. Results: When 0.100 was adopted as the cut-off value, in accordance with the manufacturer's recommendations, the sensitivity, specificity, and accuracy of the HpSA were 98.0%, 87.0%, and 92.2%, respectively. However, these values were much improved when a cut-off value of 0.300 was adopted, which was obtained with our receiver-operator characteristics curve; with this value the sensitivity, specificity, and accuracy of HpSA were 93.9%, 95.7%, and 94.8%, respectively. Conclusion: These results indicate that HpSA is a highly reliable diagnostic method for H. pylori infection and is useful in confirming eradication.