Evaluation of an office-based urine test for detecting Helicobacter pylori: A prospective pilot study

Background/Aims: To ascertain the reliability of a newly developed office-based urine test, the RAPIRUN test, used for detection of H. pylori infection. Methodology: Urine specimens from 142 consecutive patients undergoing gastroendoscopy (77 men, 65 women; mean 52.0 years) were tested with RAPIRUN at the same time. The total reaction time for the urine test is 20min. None of the patients had received any H. pylori eradicating treatment. The H. pylori status was evaluated based on 5 different tests: culture, histology, biopsy urease test, ¹³C-urea breath test, and the RAPIRUN test. A commercial office-based kit using an immunochromatographic technique was used to examine urine samples for H. pylori antibody. H. pylori status was defined as positive when the culture was positive or if 2 of the other 3 tests (histology, biopsy urease test, and ¹³C-urea breath test were positive. Results: Of 93 patients with H. pylori infection, 88 were tested as positive by RAPIRUN (sensitivity 94.6%). Of 48 patients without infection, 43 were found to be negative by RAPIRUN (specificity 89.6%). One case with an invalid urine test was excluded. Conclusions: This urine test is a rapid, inexpensive, reliable and easy-to-use tool for the diagnosis of H. pylori infection in untreated patients. It can be used for mass screening of patients' H. pylori status, particularly in children, postgastrectomy patients, uncooperative patients, and patients undergoing bismuth or proton pump inhibitor treatment.