Serodiagnosis of Helicobacter pylori-associated gastritis with a monoclonal antibody competitive enzyme-linked immunosorbent assay.

Forty-nine monoclonal antibodies against Helicobacter pylori were screened to investigate their capacity to be used in enzyme-linked immunosorbent assay (ELISA) competitive systems for the serodiagnosis of Helicobacter pylori infection. On the basis of the inhibition pattern showed by the sera of five infected patients, the antibodies were subdivided into five groups. The immunoblotting analysis showed that the antibodies recognized a total of nine different antigenic determinants. In a study of the reaction of the antibodies with 12 isolates of H. pylori a total of 9 antigenic profiles were identified. Two monoclonal antibodies, HpN44 and HpN45, which recognized a 64-kD protein, were inhibited by all 5 positive sera. Antibody HpN45 was labeled with horseradish peroxidase, and the competitive ELISA was compared with an ordinary indirect ELISA in a study of 102 patients undergoing gastroscopy. Seventy-three patients proved to be infected by H. pylori according to urease or histologic tests. The sensitivity and specificity were 90.4% and 89.6%, respectively, for the indirect ELISA and 100% and 89.6% for the HpN45 competitive assay. The three patients who were 'false seropositive' with both serologic tests had atrophic gastritis. The high diagnostic performance and simplicity of the HpN45 monoclonal competitive ELISA make it suitable for routine serodiagnosis of H. pylori infection.