Validation of a new immunoblot assay for the diagnosis of Helicobacter pylori in the Asian population

摘要: Background: Performance of commercial serological tests for Helicobacter pylori varies in different populations, largely due to strain heterogeneity and variations antigenic preparations. Currently available serology often show sub-optimal accuracy when used Asian patients. Aim: This study evaluated a recombinant antigen-based immunoblot the diagnosis H. infection Chinese patients, compared it with conventional ELISA test. Methods: Dyspeptic patients referred diagnostic endoscopy were recruited. The gold standard was based on two or more positive results among rapid urease test, histology 13C-urea breath test. Serological conducted by an test (pylori DTect; Diagnostic Technology) immunoblotting against novel antigen (C1S; Genelab), which constructed immunological screening genomic DNA library pylori. Results: A total 87 H. pylori diagnosed 40 (46%) reference tests. sensitivities 80% (95% CI: 64–91%) 90% 76–97%), whilst specificities 96% 86–96%) 87% 74–95%), respectively. respective likelihood ratios 18.6 7.0. Conclusions: Satisfactory performance is obtained use new diagnosing patients.