Comparison of two new rapid serology tests for diagnosis of Helicobacter pylori infection in Chinese patients

Abstract

Background. Rapid serology test is a simple and convenient way for diagnosing Helicobacter pylori infection. However, performances of these tests are usually less satisfactory than expected, particularly in developing countries. Aim. To evaluate the performances of two newly developed rapid serology tests for Helicobacter pylori infection. Patients. Consecutive Chinese dyspeptic patients undergoing upper gastrointestinal endoscopy. Methods. Gastric biopsies were obtained from antrum and corpus for rapid urease test and histological examination. Diagnosis of Helicobacter pylori infection was based on two or more positive results in rapid urease test, histology and [ 13C] urea breath test. Patients' sera were tested against two rapid serology tests: ASSURE Hp Rapid Test (Genelabs Diagnostics, Singapore) and SureStep (Applied Biotech, San Diego, CA, USA). Results. A total of 148 patients were evaluated and Helicobacter pylori infection was diagnosed in 78 (53%) patients by gold standard. The sensitivities of ASSURE Hp and SureStep were, respectively, 94% and 71% (p = 0.0003). Specificities of the two test kits were both 90%. The overall accuracy of ASSURE Hp was significantly higher than SureStep (92% versus 80%, p = 0.004). Conclusion. Both rapid serology tests appear to be specific in diagnosing Helicobacter pylori infection in the Chinese populations. However, the ASSURE Hp test is more sensitive and accurate than the SureStep test.