Abstract
Stool antigen tests are recommended for the diagnosis of Helicobacter pylori infection. Here, we compared two novel assays, i.e., one enzyme immunoassay (EIA) and one immunochromatography assay (ICA), with a chemiluminescence immunoassay (CLIA) that had previously been compared with rapid urease test, histology, and urea breath test. Two hundred sixty-six frozen stool samples with defined CLIA results (42 positives, 219 negatives, and 5 samples with borderline results) collected between January and May 2018 were thawed and immediately tested by EIA, ICA, and CLIA. In 248 samples with repeatedly positive/negative CLIA results, EIA and ICA were positive for 40 and 37 of 41 CLIA-positive samples and yielded negative results for 206 and 201 of 207 CLIA-negative samples, respectively. There was a high positive percent agreement (EIA, 97.6%; 95% confidence interval (95% CI), 86.3-100%; ICA, 90.2%; 95% CI, 76.9-96.7%), as well as a negative percent agreement between the assays (EIA, 99.5%; 95% CI, 97.0-100%; ICA, 97.1%; 95% CI, 93.7-98.8%). This was further supported by kappa values indicating very good agreement (CLIA vs. EIA, 0.971; CLIA vs. ICA, 0.857). In conclusion, both EIA and ICA comprise valuable assays for the detection of H. pylori antigen in stool samples.