Evaluation of an office-based urine test for detecting Helicobacter pylori: a Prospective Pilot Study.
OBJECTIVE
To ascertain the reliability of a newly developed office-based urine test, the RAPIRUN test, used for detection of H. pylori infection.


METHODS
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 20 min. 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.
Wu
D C
DC
Department of Internal Medicine, Kaohsiung Medical University Hospital, 100 Shih-Chuan 1st Road, Kaohsiung 807, Taiwan. dechwu@yahoo.com
Kuo
C H
CH
Lu
C Y
CY
Su
Y C
YC
Yu
F J
FJ
Lee
Y C
YC
Lin
S R
SR
Liu
C S
CS
Jan
C M
CM
Wang
W M
WM
D000230:Adenocarcinoma / Q000175:diagnosis* / Q000652:urine; D000328:Adult; D000368:Aged; D000907:Antibodies, Bacterial / Q000652:urine*; D003937:Diagnosis, Differential; D004415:Dyspepsia / Q000209:etiology / Q000652:urine; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D005756:Gastritis / Q000175:diagnosis* / Q000652:urine; D005773:Gastroscopy; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000652:urine; D016480:Helicobacter pylori / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010437:Peptic Ulcer / Q000175:diagnosis* / Q000652:urine; D011237:Predictive Value of Tests; D013274:Stomach Neoplasms / Q000175:diagnosis* / Q000652:urine
D000907:Antibodies, Bacterial