Evaluation of eight commercial kits for Helicobacter pylori IgG antibody detection.

Eight commercial kits and an in-house ELISA for detection of IgG antibodies against Helicobacter pylori were evaluated for their use in diagnosis of H. pylori infection and in epidemiological research: Helico-GTM (Porton-Cambridge), G. A. P. test (Bio-Rad), H. pylori antibodies ELISA (Biometra), Anti-H. pylori IgG EIA (Roche), 2nd generation H. pylori EIA (Roche), Anti-H. pylori MTP-assay (Roche), Pylori stat test kit (Whittaker), Pyloriset latex agglutination kit (Orion), and the in-house ELISA based on heat-stable antigens. Fifty-four patients with dyspepsia (31 H. pylori positive by culture or microscopy) and 68 asymptomatic persons were tested. Sensitivities for the eight kits were 71%, 77%, 90%, 84%, 87%, 94%, 90%, 87%, and 87%, specificities were 74%, 65%, 74%, 74%, 83%, 83%, 70%, 65%, and 65%, respectively. For epidemiological use the estimated seroprevalence varied within approximately 15% in all age groups. Sensitivities and specificities obtained in different studies reveal as great differences in the results with the same kit as between results obtained with different kits in the same study. Kits with the highest sensitivities tend to be the same in all studies. It is therefore more important to test a kit in the population to which it is to be applied than to choose a specific kit.