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Post‐treatment diagnostic accuracy of a new enzyme immunoassay to detect Helicobacter pylori in stools
Author(s) -
Costa F.,
Mumolo M. G.,
Bellini M.,
Romano M. R.,
Manghetti M.,
Paci A.,
Maltinti G.,
Marchi S.
Publication year - 2001
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.2001.00928.x
Subject(s) - medicine , helicobacter pylori , urea breath test , immunoassay , rapid urease test , breath test , gastroenterology , confidence interval , urease , diagnostic accuracy , helicobacter pylori infection , urea , immunology , antibody , chemistry , organic chemistry
Background: Helicobacter pylori has attracted increasing attention among gastroenterologists because of its pathogenic potential, stimulating the search for non‐invasive diagnostic tests. Aims: In this study the efficacy of a new enzyme immunoassay designed to detect H. pylori antigens in stools (HpSA) was evaluated before and after eradication therapy. Methods: HpSA was performed on stool samples collected from 268 patients whose H. pylori status was defined on the basis of concordant results for the 13 C‐urea breath test, rapid urease test and histology. The H. pylori ‐positive patients were treated with a 1‐week triple therapy to eradicate the infection. One (T30) and 3 months (T90) after the end of therapy, 13 C‐urea breath test and HpSA were repeated in the treated patients. Results: The overall diagnostic accuracy of HpSA at T30 (83%, 95% confidence interval (CI) 77–89%) was significantly lower in comparison to the values obtained at baseline (94%, 95% CI: 91–97%) and at T90 (97%, 95% CI: 94–99%). No significant difference was found between the diagnostic accuracy of HpSA at baseline and at T90 ( P =0.253). Conclusions: The present data suggest that HpSA provides a low diagnostic accuracy when used shortly after treatment. It needs a longer period of follow‐up (8–12 weeks) to reach a reliability comparable to the 13 C‐urea breath test.