Comparison of chemiluminiscence versus lateral flow assay for the detection of Helicobacter pylori antigen in human fecal samples

Abstract

Abstract Helicobacter pylori is a Gram-negative bacterium that causes chronic gastric inflammation, which can lead to gastric neoplasia. Therefore, early diagnosis of H. pylori infection is crucial for effective treatment and prevention of complications. The aim of this study was to compare the sensitivity and specificity of the STANDARD™ F H. pylori Ag FIA stool antigen test (SD Biosensor) with the LIAISON® Meridian H. pylori SA for the diagnosis of H. pylori infection. A total of 133 stool samples from patients with suspected H. pylori infection were compared using the STANDARD™ F H. pylori Ag FIA stool antigen test (SD Biosensor), based on lateral flow assay, with the LIAISON® Meridian H. pylori SA. Of the 45 positive samples with LIAISON, 44 were also positive while 1 was negative in the STANDARD™ antigen test. However, this discrepant sample showed a chemiluminescence index of 1.18, very close to the cut-off point of 1. On the other hand, of 88 negative samples obtained with LIAISON, 83 were negative and 5 were positive in the STANDARD™ antigen test. Moreover, STANDARD™ F H. pylori Ag FIA assay has shown a sensitivity of 97.8% (95% CI: 88.2-99.9), a specificity of 94.3% (95% CI: 87.2-98.1), a PPV of 83.9% (95% CI: 68.9-92.4) and a NPV of 99.3% ((95% CI: 95.3-99.9). In conclusion, the STANDARD™ F H. pylori Ag FIA (SD Biosensor) on the STANDARD™ F2400 analyser is a highly sensitive, specific and suitable assay for the detection of H. pylori in stool samples.