Background: Helicobacter pylori has been recognised as a major gastric pathogen. Many techniques to identify infection have been developed, including histology and culture as invasive tests and the urea breath test as non-invasive technology. Recently, another non-invasive test based on the detection of H. pylori antigens in stool specimens was introduced.
Aim: To evaluate the sensitivity and specificity of this novel enzyme-linked immunosorbent assay for detection of H. pylori infection in comparison with histology.
Methods: Stool specimens of 72 consecutive patients who had gastroscopy with biopsy at our endoscopy unit were collected and frozen at -20 degrees C until further processing. H. pylori status was determined as part of the routine histological work-up. In a second step, histology slides were reviewed by a pathologist who specialized in gastrointestinal pathology. Stool samples were tested for the presence of H. pylori antigen using the PREMIER H. pylori Stool Antigen Test. Sensitivity and specificity of routine histopathology and the H. pylori Stool Antigen Test were determined using the diagnosis of the expert gastrointestinal histopathologist as gold standard.
Results: Routine histopathology resulted in a sensitivity of 90% and specificity of 92% in the diagnosis of H. pylori. These results compare well with the results of the H. pylori Stool Antigen Test that revealed a sensitivity of 80% and a specificity of 98%.
Conclusion: The H. pylori Stool Antigen Test is a promising non-invasive test for the detection of H. pylori infection.