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Detection of serum antibodies to Helicobacter pylori by an immunochromatographic method
J C Anderson1, E Cheng, M Roeske
1Department of Medicine, State University of New York at Stony Brook, USA.
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.