Detection of serum antibodies to Helicobacter pylori by an immunochromatographic method

Abstract

Objectives: FlexsureHP is a bi-directional immunochromatographic device for detection of IgG antibodies to Helicobacter pylori in human serum. This test, requiring only three steps and a 4-min incubation, can be used as an office-based diagnostic test. The goal of this study was to compare the sensitivity and specificity of the FlexsureHP, when performed by a clinician, with the established ELISA in the evaluation of clinical samples in an office setting.

Results: The sensitivity and specificity of the FlexsureHP, 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 when the ELISA was compared with biopsy data.

Conclusion: The immunochromatographic device, FlexsureHP, is a rapid, highly sensitive, and moderately specific office-based diagnostic test for H. pylori infection.