An evaluation of a new in-house serum and urine ELISA test for detection of Helicobacter pylori infection in Thai population

Abstract

Objective: Non-invasive tests play significant roles in the test-and-treat approach of Helicobacter pylori management. The detection of Helicobacter pylori antibodies in urine and serum is an easy and inexpensive way to diagnose this infection. In the present study, the authors developed an in-house serum and urine ELISA tests for H. pylori antibodies and evaluated their performance in a Thai population.

Material and method: One hundred thirty eight dyspeptic patients were recruited. All subjects underwent upper endoscopy and one antral biopsy was obtained for rapid urease test, which was used as a standard reference. Urine and serum samples were collected before the procedure to run in-house ELISA test.

Results: Thirty (22%) subjects were positive for the rapid urease test and 108 (78%) were negative. Urine and serum optical density were significantly lower in the urease negative group (p = 0.011 and p < 0.001 respectively), while there were no differences in age, gender, or endoscopic findings between the two groups. Sensitivity, specificity, negative predictive value, positive predictive value, and accuracy of urine and serum ELISA tests were 72% vs. 96.3%, 63.5% vs. 627%, 89.6% vs. 98.5%, 33.3% vs. 40.6%, and 64.5% vs. 69.8% respectively.

Conclusion: In-house serum ELISA test for H. pylori antibodies yielded a very good sensitivity with acceptable specificity, whereas urine ELISA was unable to produce satisfactory sensitivity or specificity