Comparison of tests for assessment of Helicobacter pylori eradication: results of a multi-centre study using centralized facility testing.

Background The accuracy of diagnostic tests to assess Helicobacter pylori eradication has rarely been performed. Aim To compare the tests most commonly used for this purpose, i.e. histology, culture and 13 C urea breath test performed in centralized facilities. Methods Prospective study where patients were included in four centres and diagnostic tests performed centrally by biologists experienced in the field. Gastric biopsies were obtained from antrum and corpus (two for histology, two for culture from each site) 4-6 weeks after an eradication treatment The definition of a gold standard for H. pylori-positive patients was either a positive culture or both positive histology and urea breath test results. Results Ninety-seven patients for whom data on histology, culture and 13 C urea breath test were available were included. The majority were females (60%) suffering from non-ulcer dyspepsia (52%) and having received proton-pump inhibitor-based triple therapy (62%). Forty-one per cent of the patients were H. pylori-positive according to the gold standard. The sensitivities were 90%, 95% and 92.5% and the specificities 100%, 98.2% and 100% for culture, histology and 13 C urea breath test, respectively. Conclusion All the methods had excellent specificity but the sensitivity ranged between 90 and 95%. The combination of two techniques which increases the sensitivity to virtually 100% is recommended in situations where the eradication treatment requires a precise evaluation such as in clinical trials.