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Reproducibility of the 14C urea breath test repeated after 1 week
Objectives:
The aim of this study was to determine the numerical and categorical reproducibility of the 14C urea breath test in a routine clinical setting.
Background:
The 14C urea breath test is used for diagnosis of Helicobacter pylori infection and is regarded by some centers as the gold standard.
Methods:
In 140 referrals, duplicate tests were performed 1 wk apart. Eighteen patients were excluded because they had taken antibiotics or had changed medication that could influence the gastric urease activity between the tests.
Results:
The limits of agreement between the repeated tests were 45-234%. Hence, the numerical result of a repeated test was 95% likely to differ from the first with a factor of approximately two or less. However, when patients were classified as "positive" or "negative" according to our previously determined cut-off limit, only three patients were discordantly classified by the two tests. The observed agreement between the tests was 98%, and the chance-corrected proportional agreement (kappa) was 95%, which is far better than that reported for the histological diagnosis of gastric H. pylori infection.
Conclusion:
The diagnostic reproducibility of the urea breath test was very good.