Enzymelinked immunosorbent assay kit (URINELISA, Otsuka, JAPAN), which was recently developed for detection of the antibody to Helicobacter pylori (Hp) in urine, was evaluated for its clinical usefulness in 242 asymptomatic Japanese persons. Serum immunoglobulin G antibody to Hp was concomitantly measured by a commercialized kit (Determiner H. pylori, Kyowa, JAPAN). Results of radiography of the upper gastrointestinal tract and the value of serum pepsinogen I and II were also recorded. The cases with both pepsinogen I≤70, μg/1 and I /II ratio ≤3 were regarded as positive. Additionally, gastrointestinal endoscopy was performed for volunteers to confirm the presence or absence of Hp, using rapid urease test and microscopic examination. The calculated sensitivity, specificity, and consistency of URINELISA against Determiner were 91.9,85.3, and 88.6%, respectively, which seemed satisfactory for clinical use. Those against endoscopic diagnosis were 97.5,30.0, and 84.0 %, respectively. Most of the subjects with negative result in URINELISAw ere also negative in pepsinogen test. In the population with positive in URINELISA, peptic diseases including gastroduodenal ulcers, hyperplastic polyps, gastritis, and duodenitis were found with higher frequency than those in the population with negative result.
In summary, URINELISAse ems suitable not only for the detection of Hp in clinical setting but also as one of screening methods for the upper gastrointestinal disorders.
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