Evaluation and comparison of two immunodiagnostic assays for Helicobacter pylori antibodies with culture results.

Several commercially available serological kits have been used as an alternative to endoscopy for the diagnosis of Helicobacter pylori infection. We evaluated the performance of two such kits, Serion H. pylori immunotab kit (Serion, Wurzberg, West Germany) and Pyloragen H. pylori test kit (Hypcor Biomedical Inc., Irvine, CA). Gastric biopsy and serum samples were collected from 345 consecutive dyspeptic patients. The culture and or direct smear of the biopsy was positive for H. pylori in 228 patients (66%), whereas 117 patients (34%) were found to be H. pylori negative. We determined the serological response of the patients using the two kits, both of which are based on the principle of enzyme-linked immunosorbent assay. Comparing the serum immunoglobin G (IgG) and IgA (in a limited number of cases) responses to H. pylori status, the sensitivity, the specificity, positive predictive value, and negative predictive value were calculated. The corresponding data for the different tests were 64%, 79%, 84%, and 56% for Serion IgC, 32%, 94%, 88%, and 52% for Serion IgA, and 88%, 17%, 62%, and 46% for Pyloragen IgG, respectively. We conclude that there is a poor correlation between the presence of H. pylori infection and the antibody response, which could be explained either because of low sensitivities and specificities of the commercial kits used for the measurement of antibodies to H. pylori in the serum or because of poor immunological response in our patients to H. pylori antigens.