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 e radication has rarely been performed. Aim To compare the tests most commonly used for this purpose, i.e, histolog y, culture and C-13 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 eithe r a positive culture or both positive histology and urea breath test result s. Results Ninety-seven patients for whom data on histology, culture and C-13 urea breath test were available were included. The majority were females (6 0%) suffering from non-ulcer dyspepsia (52%) and having received proton-pum p inhibitor-based triple therapy (62%). Forty-one per cent of the patients were H. pylori-positive according to the gold standard. The sensitivities w ere 90%, 95% and 92.5% and the specificities 100%, 98.2% and 100% for cultu re, histology and C-13 urea breath test, respectively. Conclusion All the methods had excellent specificity but the sensitivity ra nged between 90 and 95%. The combination of two techniques which increases the sensitivity to virtually 100% is recommended in situations where the er adication treatment requires a precise evaluation such as in clinical trial s. (C) 2000 Lippincott Williams & Wilkins.