Evaluation of urinary rapid test for Helicobacter pylori in general practice

There is increasing interest in noninvasive tests for the diagnosis of Heli cobacter pylori (H. pylon) infection. One such test, a urine-based rapid te st kit (RAPIRUN H. pylori Antibody, Otsuka Pharmaceutical Co., Ltd.) for de tection of antibody to H. pylori, has been developed and is considered idea l. 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 si mple. Only 10-20 minutes are required to complete an assay, and no instrume nts are needed. The aim of this study was to examine the clinical usefulnes s of this urine-based rapid test. A total of 189 patients, including 76 pat ients with gastroduodenal disease, were recruited. A pair of random single- void urine and serum samples was collected from each of the 189 patients, a nd 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 diagnos tic methods using endoscopic biopsy specimens such as culture, histology, a nd rapid urease test were also performed. The sensitivity, specificity, and accuracy of the urinary rapid test were evaluated on the basis of the thre e serum ELISA results or the invasive diagnostic results. In addition, vari ous urinalyses were performed, and the effects of substances existing in ur ine on the urinary rapid test results were examined. Of the 189 patients, t he 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 E LISA results, the sensitivity, specificity, and accuracy of the urinary rap id test were 93.7, 88.9, and 92.2%, respectively. On the basis of the biops y-based test results, the sensitivity of the urinary rapid test was 100% an d its accuracy (95.2%) was equivalent or superior to that of each serum-bas ed ELISA. In addition, no significant differences were observed between gro ups positive and negative on urinary rapid testing In any urinalysis parame ter examined. The novel urinary rapid test kit evaluated in this study enab les simple, rapid, and accurate diagnosis of H. pylori infection, and is an ideal test method for point-of-care testing. J. Clin. Lab. Anal. 15:154-15 9, 2001. (C) 2001 Wiley-Liss, Inc.