Evaluation of the Helicobacter pylori stool antigen test for the detection of Helicobacter pylori infection before and after eradication / 中华消化杂志

ABSTRACT

Objective The aim of this study was to assess the reliability of a newly developed enzymeimmumoassay, the Helicobacter pylori (H. pylori) stool antigen (HpSA) test, for the detection of H.pylori infection before and after eradication. Methods The H.pylori infected patients referred to our department were included. They were divided into two groups. The 331 patients in group A had intact stomach, and 65 patients in group B had history of subtotal gastrectomy. All patients underwent gastroscopy with biopsies for rapid urease test (RUT) and histology, which was viewed as “gold standard”. H.pylori status was defined as positive or negative with both RUT and histology presenting concordant positive or negative results. The results of these reference tests were compared with those obtained by HpSA test and ()~(13)C-urea breath test (()~(13)C-UBT). In addition, Fifty-six-positive patients in group A, constituting group C, were treated with 1-week triple therapy. At the 28 th day after the end of therapy, the patients underwent another ()~(13)C-UBT which was also defined as “gold standard”. The stool specimens were collected on days 1, 7, 14, 21, and 28 after completion of therapy and were used to detect the antigen of H.pylori by HpSA. Results In group A, 175 patients were defined as H.pylori-positive and 156 as negative by the “gold standard”. The sensitivity and specificity of the HpSA test was (95.4%) and 91.0%, respectively. There was no significant difference between HpSA test and ()~(13)C-UBT. In group B, 30 patients were defined as H.pylori-positive and 35 as negative by the “gold standard”. The sensitivity of the HpSA test and ()~(13)C-UBT was 90.0% and 66.7%, respectively (P