Urine-based ELISA testing for the diagnosis and confirmation of eradication of helicobacter pylori infection

Background and aimThe aim of this study was to evaluate the sensitivity of urine-based ELISA test both in the initial diagnosis of Hp infection and in the confirmation of the eradication after treatment.Material and MethodsFifty-four Hp?infected patients (36 F, 18 M, mean age: 45.8±10.4) out of 117 patients who underwent endoscopy for dyspepsia enrolled in the study. Serum and urine samples were collected from the patients and 13C urea breath test (UBT) applied before and 6 weeks after the treatment. Patients were considered to be Hp positive if 3 tests (rapid urease test, UBT and histology) were positive. Patients received triple therapy consisting of claritromicine, amoxicillin and lansoprazole for 14 days. Urine samples were analyzed using an IgG ELISA (URINELISA) and serum ELISA (EUROIMMUN) at the initial, 6th week and 6th month visits.ResultsThe eradication rates of Hp infection were 67% according to ITT and 68 % according to PP analysis. The sensitivity of serum ELISA and URINELISA were 100% and 69% at the initial diagnosis, respectively. URINELISA test became negative in 8 out of 23 patients (35%) at 6th week and 18 out of 22 patients (82%) who were successfully eradicated at 6th month.ConclusionAlthough the sensitivity of urine based ELISA test is over 80% at 6th month?s after the therapy, it?s not useful for the confirmation of Hp eradication because of the low sensitivity at the initial diagnose.Key words: Helicobacter pylori, eradication control, URINELISA