EVALUATION OF A NEW IMMUNODIAGNOSTIC ASSAY FOR HELICOBACTER-PYLORI ANTIBODY DETECTION - CORRELATION WITH HISTOPATHOLOGICAL AND MICROBIOLOGICAL RESULTS

Infection with Helicobacter pylori has been associated with the pathog enesis of chronic active gastritis and gastric and duodenal ulcer dise ase. Detection of immunoglobulin G antibodies to H. pylori offers a si mple alternative to direct detection of the organism in biopsied tissu e by culture or histopathological methods. A rapid flow-through membra ne-based enzyme immunoassay for the detection of human immunoglobulin G antibodies to H. pylori has been developed and evaluated. Clinical e valuations were performed with 256 patient serum samples obtained from four clinical sites. Biopsy samples were obtained by endoscopic proce dures at the same time as the serum samples, and were histopathologica lly and microbiologically categorized for the presence or absence of H . pylori. Sensitivity and specificity for this rapid enzyme immunoassa y were 92 and 88%, respectively, compared directly with endoscopy resu lts. After discordant results were resolved by a quantitative microwel l enzyme-linked immunosorbent assay, the resulting sensitivity and spe cificity were 94 and >99%, respectively. These results indicate that t his rapid enzyme immunoassay is a useful technique to determine H. pyl ori infection status and is a viable alternative to invasive endoscopi c procedures.