Development and application of a novel screening PCR assay for direct detection of 'Helicobacter heilmannii'-like organisms in human gastric biopsies in Southeast England.

A novel PCR assay (HHLO-16) to screen for presence of 'Helicobacter heilmannii'-like organisms (HHLO) direct from gastric biopsies is described. As 'H. heilmannii' is generally uncultivable, diagnosis of infection is reliant on histology; thus prevalence may be underestimated. Analysis of an HHLO histology-positive human gastric biopsy and 15 gastric biopsies from domestic cats demonstrated that the HHLO-16 assay was more sensitive than an alternative available species-specific PCR assay. Further testing of 131 gastric biopsies from dyspeptic patients demonstrated an HHLO prevalence rate of 2.3% in Southeast England. Subsequent combination of the HHLO-16 assay with a H. pylori-specific PCR assay in a multiplex format (HpHh assay), and repeat analysis of the 131 biopsies showed the HpHh assay was as sensitive as each individual test. This novel PCR assay provides simple concomitant testing of dyspeptic patients for both HHLOs and H. pylori, thereby rapidly identifying individuals requiring eradication therapy.