Helicobacter Pylori Infection Clinical Trial
Official title:
Study of the Performances of a Fast Diagnosis Immunochromatographic Test for the Detection of Helicobacter Pylori (H. Pylori) Antigens in Child Stool
The diagnostic tests used to detect Helicobacter pylori (H. pylori) infection are either
direct and invasive, as in culture, histology and the rapid urease test (RUT) or noninvasive,
such as serology, the 13C-Urea breathe test or the stool antigen test. However, there is no
single reference method to detect the H. pylori infection reliably and accurately. The
specificity of gastric biopsy cultures is 100%, but the sensitivity is lower. Histology and
RUT provide excellent diagnostic accuracy, but the detection of H. pylori is decreased in
cases of bleeding peptic ulcers or gastric atrophy. Therefore, it is recommended that at
least two tests should agree when defining the H. pylori infection in children. Quantitative
real-time polymerase chain reaction (qPCR)-based methods have been shown to be the most
reliable for H. pylori detection in adults and in children. In children, the reference method
for H. pylori infection detection is invasive, namely upper digestive endoscopy with gastric
biopsy for histology, culture, RUT and qPCR. A noninvasive alternative to detect H. pylori
antigen in stools could use a quick one-step immuno-chromatographic technique.
The aim of this study was to assess the performance of a new quick, noninvasive, one-step
immuno-chromatographic, stool antigen test (ALERE Inc, Jouy-en-Josas, France) for the
detection of H. pylori infection in children.
n/a
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