Comparison of the diagnostic accuracy of five different stool antigen tests for the diagnosis of Helicobacter pylori infection

Abstract

Background: Several noninvasive diagnostic tests based on the detection of Helicobacter pylori stool antigen (HpSA) have been developed. The aim of the study was to compare the diagnostic accuracy of 5 HpSA tests-2 monoclonal enzyme immunoassay tests (EIAs: the Premier Platinum HpSA Plus test and Helicobacter pylori Antigen (Hp Ag) test) and 3 rapid immunochromatographic assay (ICA) tests (the ImmunoCard STAT! HpSA test, one step HpSA test, and H. pylori fecal antigen test)--for diagnosing H. pylori infection in adult patients with dyspeptic symptoms before eradication therapy.

Materials and methods: A total of 198 patients with dyspeptic symptoms were included in the study. A gastric biopsy was collected for histopathology and rapid urease testing. Stool specimens for HpSA testing were also collected. Patients were considered H. pylori positive if two invasive tests (histological and rapid urease tests) were positive.

Results: The sensitivity and specificity were 92.2% and 94.4%, respectively, for the Premier Platinum HpSA Plus test; 48.9% and 88.9%, respectively, for the HP Ag test; 86.7% and 88.9, respectively, for the One Step HpSA test; 68.9% and 92.6%, respectively, for the ImmunoCard STAT! HpSA test; and 78.9% and 87%, respectively, for the H. Pylori fecal antigen test.

Conclusions: The Premier Platinum HpSA Plus EIA test was determined to be the most accurate stool test for diagnosing H. pylori infections in adult dyspeptic patients. The currently available ICA-based tests are fast and easy to use but provide less reliable results.

Keywords: Helicobacter pylori diagnosis; immunoassay; sensitivity; specificity; stool antigen test.