DETECTION OF SERUM ANTIBODIES TO HELICOBACTER-PYLORI BY AN IMMUNOCHROMATOGRAPHIC METHOD

Objectives: Flexsure(TM)HP is a bi-directional immunochromatographic d evice for detection of IgG antibodies to Helicobacter pylori in human serum, This test, requiring only three steps and a 4-min incubation, c an be used as an office-based diagnostic test, The goal of this study was to compare the sensitivity and specificity of the Flexsure(TM)HP, when performed by a clinician, with the established ELISA in the evalu ation of clinical samples in an office setting, Results: The sensitivi ty and specificity of the Flexsure(TM)HP, compared with the biopsy, is 92.4% and 83.0%, respectively, with a positive predictive value of 88 .4%, This was not significantly different from the results obtained wh en the ELISA was compared with biopsy data, Conclusion: The immunochro matographic device, Flexsure(TM)HP, is a rapid, highly sensitive, and moderately specific office-based diagnostic test for H. pylori infecti on.