ABSTRACT
BACKGROUND: A new rapid urine test was developed to detect anti-Helicobacter pylori antibody in urine using the principle of immunochromatography. The accuracy of this test in the Chinese population remains to be defined. AIM: To evaluate a new rapid urine test for the diagnosis of H. pylori infection in the Chinese population. METHODS: Eligible patients without previous treatment of H. pylori were recruited. In-house rapid urease test and histology were used as the gold standard. The rapid urine test (RAPIRUN H. pylori antibody) was performed and the results were compared with the gold standard. RESULTS: One hundred and twenty-three patients were eligible for analysis and 61 (50%) were H. pylori positive by the gold standard. The rapid urine test showed a sensitivity, specificity, positive predictive value, negative predictive value and accuracy of 96.7%, 95.2%, 95.2%, 96.7% and 95.9%, respectively. Results were obtained within 20 min and no special laboratory support was required. CONCLUSIONS: The rapid urine test by immunochromatography is highly accurate for the diagnosis of H. pylori infection in untreated Chinese patients.
Subject(s)
Antibodies, Bacterial/urine , Helicobacter Infections/urine , Helicobacter pylori/immunology , Adolescent , Adult , Aged , Aged, 80 and over , China/epidemiology , Evaluation Studies as Topic , Female , Helicobacter pylori/enzymology , Humans , Immunochemistry , Male , Middle Aged , Reagent Kits, Diagnostic , Sensitivity and Specificity , Urease/metabolismABSTRACT
BACKGROUND: Numerous serological tests for the detection of Helicobacter pylori infection have been developed. However, many perform poorly when evaluated in the Chinese population. AIM: To search for optimal serological tests for the detection of H. pylori infection in Chinese patients. METHODS: Consecutive dyspeptic patients referred for upper endoscopy were recruited. During endoscopy, gastric biopsies were taken for the CLOtest and histological examination. Patients were then given a 13C-urea breath test. Sera were used to test for H. pylori infection, employing three commercial enzyme-linked immunosorbent assay kits (pylori DTect, HP IgG and GAP IgG). Results were compared with the gold standard defined by the CLOtest, histology and 13C-urea breath test. RESULTS: Among the 142 patients (47 male, 95 female; mean age, 49 years) recruited, 81 (57%) were H. pylori-positive, 57 (40%) were H. pylori-negative and four (3%) were defined to be indeterminate. Using a self-defined cut-off value after calculation, the best accuracies for the pylori DTect, HP IgG and GAP IgG tests were 97%, 91% and 80%, respectively. CONCLUSIONS: The pylori DTect test is an optimal serological test for the detection of H. pylori infection in Hong Kong Chinese patients. The HP IgG test may be used as an alternative.