Evaluation of urine ELISA test for detecting Helicobacter pylori infection in Taiwan: a prospective study.
OBJECTIVE
To evaluate the diagnostic accuracy and clinical utility of a new ELISA (URINELISA) test for detecting Helicobacter pylori (H pylori) antibody in the urine of Taiwanese population.


METHODS
In this prospective study, 317 consecutive dyspeptic patients (171 men, 146 women; mean age, 51.0 years) were included. They underwent gastroendoscopy for evaluation. Invasive tests, including culture, histology, and rapid urease test (RUT), and non-invasive (13)C-urea breath test were preformed. At the same time, urine specimens were collected for URINELISA. The status of H pylori infection was considered as positive when either culture was positive, or when two of the other, RUT, histology or 13C-UBT, were positive.


RESULTS
The sensitivity, specificity, positive predictive value, and negative predictive value of URINELISA are 91.7% (211/230), 90.8% (79/87), 96.3% (211/219), and 80.6% (79/98) respectively.


CONCLUSIONS
This URINELISA test is reliable, inexpensive and easy-to-use. The high diagnostic accuracy warrants the use of URINELISA as a first-line screening tool for diagnosis of H pylori infection in untreated patients.
Kuo
Fu-Chen
FC
Department of Gynecology and Obstetrics, E-Da Hospital, I-Shou University, Kaohsiung, Taiwan, China.
Wang
Sheng-Wen
SW
Wu
I-Chen
IC
Yu
Fang-Jung
FJ
Yang
Yuan-Chieh
YC
Wu
Jeng-Yih
JY
Wang
Wen-Ming
WM
Wu
Deng-Chyang
DC
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000907:Antibodies, Bacterial / Q000652:urine; D001944:Breath Tests; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods* / Q000706:statistics & numerical data; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000382:microbiology; D016480:Helicobacter pylori / Q000276:immunology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D013624:Taiwan
D000907:Antibodies, Bacterial