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.
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. pyloriinfection.
Authors: D Vaira; J Holton; M Menegatti; C Ricci; F Landi; A Ali'; L Gatta; C Acciardi; S Farinelli; M Crosatti; S Berardi; M Miglioli Journal: Gut Date: 1999-07 Impact factor: 23.059