Usefulness of a novel enzyme immunoassay for the detection of Helicobacterpylori in feces

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