1. Clinical usefulness of urine-based enzyme-linked immunosorbent assay for detection of antibody to Helicobacter pylori: a collaborative study in nine medical institutions in Japan
- Author
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Shojiro Hariya, Hitoshi Sekine, Masayuki Sawamura, Takayoshi Toyota, Toshiko Kumagai, Mototsugu Kato, Masahiro Asaka, Taiji Akamatsu, Taimei Kaneko, Masao Saito, Kunihiro Minami, Masaaki Kosaka, Shuichi Ohara, Yasuhiro Sanai, Masahiro Abe, Tsutomu Katsuyama, Tetsuya Tachikawa, Osamu Nishizawa, and Kendo Kiyosawa
- Subjects
Male ,Quality Control ,Diagnostic methods ,Biopsy ,Antibody Affinity ,Enzyme-Linked Immunosorbent Assay ,Urine ,Sensitivity and Specificity ,Helicobacter Infections ,Western blot ,Predictive Value of Tests ,medicine ,Humans ,Multicenter Studies as Topic ,chemistry.chemical_classification ,medicine.diagnostic_test ,biology ,Helicobacter pylori ,business.industry ,Gastroenterology ,Reproducibility of Results ,General Medicine ,Serum samples ,biology.organism_classification ,Antibodies, Bacterial ,Infectious Diseases ,Enzyme ,chemistry ,Evaluation Studies as Topic ,Immunology ,biology.protein ,Female ,Antibody ,business - Abstract
Background. A urine-based enzyme-linked immunosorbent assay (ELISA) kit for detection of antibody to Helicobacter pylori has been developed in Japan. Urine samples can be obtained noninvasively and are easier and safer to handle than are serum samples. The aim of this study was to examine the clinical usefulness of this urine-based ELISA kit. Materials and Methods. A pair of random, single-void urine and serum samples was collected from each of 1,061 subjects, including 238 patients with gastroduodenal disease. The sensitivity and specificity of the urine-based ELISA was compared with those of three commercially available serum-based ELISA kits. For those patients with gastroduodenal disease, the urine- and serum-based ELISA results were also compared with those for other diagnostic methods using endoscopic biopsy specimens, such as culture, histology, and rapid urease tests. Results. Based on the three serum-based ELISA results, the sensitivity, specificity, and accuracy of the urine-based ELISA were 97.7%, 95.6%, and 96.8%, respectively. On the basis of the biopsy test results, the sensitivity (96.2%), specificity (78.9%), and accuracy (91.0%) of the urine-based ELISA were almost equivalent or superior to all three serum-based ELISAs tested. In addition, 10 of the 12 false-positive cases for urine-based ELISA were confirmed to be true positives for antibodies to H. pylori by Western blot analysis and inhibition ELISA. Conclusions. The urine-based ELISA (URINELISA H. pylori Antibody) is very accurate and should be useful as an alternative to serum-based ELISAs for screening of H. pylori infection.
- Published
- 2000