Abstract
There is increasing interest in noninvasive tests for the diagnosis of Helicobacter pylori (H. pylori) infection. One such test, a urine‐based rapid test kit (RAPIRUN H. pylori Antibody, Otsuka Pharmaceutical Co., Ltd.) for detection of antibody to H. pylori, has been developed and is considered ideal. In addition to its noninvasiveness and safe handling—due to use of urine as a sample—the assay procedure used for the urinary rapid test is very simple. Only 10–20 minutes are required to complete an assay, and no instruments are needed. The aim of this study was to examine the clinical usefulness of this urine‐based rapid test. A total of 189 patients, including 76 patients with gastroduodenal disease, were recruited. A pair of random single‐void urine and serum samples was collected from each of the 189 patients, and antibody to H. pylori in the urine and serum samples was measured using the urine‐based rapid test kit and three commercially available serum‐based ELISA kits. For the patients with gastroduodenal disease, invasive diagnostic methods using endoscopic biopsy specimens such as culture, histology, and rapid urease test were also performed. The sensitivity, specificity, and accuracy of the urinary rapid test were evaluated on the basis of the three serum ELISA results or the invasive diagnostic results. In addition, various urinalyses were performed, and the effects of substances existing in urine on the urinary rapid test results were examined. Of the 189 patients, the urinary rapid test was positive for 110 (58.2%), negative for 78 (41.3%), and invalid for only one patient (0.5%). Based on the three serum‐based ELISA results, the sensitivity, specificity, and accuracy of the urinary rapid test were 93.7, 88.9, and 92.2%, respectively. On the basis of the biopsy‐based test results, the sensitivity of the urinary rapid test was 100% and its accuracy (95.2%) was equivalent or superior to that of each serum‐based ELISA. In addition, no significant differences were observed between groups positive and negative on urinary rapid testing in any urinalysis parameter examined. The novel urinary rapid test kit evaluated in this study enables simple, rapid, and accurate diagnosis of H. pylori infection, and is an ideal test method for point‐of‐care testing. J. Clin. Lab. Anal. 15:154–159, 2001. © 2001 Wiley‐Liss, Inc.