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Leung, W.K. et al.

Leung, Chow, Ng, Chan, Chung, Sung,

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

BACKGROUND: Performance of commercial serological tests for Helicobacter pylori varies in different populations, largely due to strain heterogeneity and variations in antigenic preparations. Currently available serology tests often show sub-optimal accuracy when used for Asian patients. AIM: This study evaluated a recombinant antigen-based immunoblot for the diagnosis of H. pylori infection in Chinese patients, and compared it with a conventional ELISA test. METHODS: Dyspeptic patients referred for diagnostic endoscopy were recruited. The gold standard for H. pylori infection was based on two or more positive results among rapid urease test, histology and (13)C-urea breath test. Serological diagnosis of H. pylori infection was conducted by an ELISA test (pylori DTect; Diagnostic Technology) and an immunoblotting against a novel recombinant antigen ( C1S; Genelab), which was constructed by immunological screening of the genomic DNA library of H. pylori. RESULTS: A total of 87 patients were evaluated and H. pylori infection was diagnosed in 40 (46%) by the reference tests. The sensitivities of the ELISA and immunoblot were 80% (95% CI: 64--91%) and 90% (95% CI: 76--97%), whilst the specificities were 96% (95% CI: 86--96%) and 87% (95% CI: 74--95%), respectively. The respective likelihood ratios of the two tests were 18.6 and 7. 0. CONCLUSIONS: Satisfactory performance is obtained by the use of the new recombinant antigen-based immunoblot for diagnosing H. pylori infection in Chinese patients.[1]

References

Validation of a new immunoblot assay for the diagnosis of Helicobacter pylori in the Asian population. Leung, W.K., Chow, T.P., Ng, E.K., Chan, F.K., Chung, S.C., Sung, J.J. Aliment. Pharmacol. Ther. (2001) [Pubmed]

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