DETECTION OF HELICOBACTER PYLORI STOOL ANTIGEN BY NON-INVASIVE ENZYME IMMUNOASSAY
摘要
Objective. To evaluate the clinical utility of a new non-invasive enzyme immunoassay(EIA) for the diagnosis of Helicobacter pylori (H.pylori) infection. Methods. Stool specimens of 63 patients were collected and tested by using a commercial kit for detecting Helicobacter pylori stool antigen (HpSA), of which 61 patients also underwent 13C-Urea breath test (13C-UBT). The tissue samples of 31 patients were obtained endoscopically and were examined with histologic technique (Warthin-Starry silver stain).Regarded 13C-UBT as a golden standard, HpSA test and histologic techniques were evaluated. Using this method,we also investigated the positive rate of H.Pylori infection in children in Beijing.Results.The sensitivity and specificity of HpSA test were 94.7% and 95.1% respectively; the positive and negative predictive values were 97.3% and 91.7% respectively; and the accuracy was 95.1%.The results showed the prevalence of H.pylori infection was 26.0% in children (3～18 years) of district of Xicheng in Beijing. After treatment, HpSA seems to disappear rapidly(3～5 days) from the feces. Conclusion. The detection of HpSA in stool samples by HpSA test is a rapid noninvasive test for detecting H.pylori infection, and has both high sensitivity and high specificity. It is suitable for screening and diagnosis of H.pylori infection, monitoring the treatment efficacy in routine in all hospitals.