Validation of serological tests for Helicobacter pylori infection in an Irish population

Serological tests for Helicobacter pylori using laboratory and 'office' formats are commonly used, easy to perform, inexpensive and widely available. Local validation of test performance is required.

This study examined the performance of a laboratory and 'office' ELISA in a population of Irish dyspeptics presenting for endoscopy.

Consecutive patients presenting for endoscopy had blood drawn at sedation. Samples were analysed using two ELISA formats; a standard laboratory format and an 'office' ELISA test card. H. pylori infection was diagnosed by analysis of antral and corpus biopsies using the rapid urease test, culture and histology. A combination of two positive invasive tests was considered indicative of infection.

The sensitivity and specificity of laboratory ELISA was 82.4% and 85% respectively while the values for the 'office' ELISA were 87.7% and 85.7% respectively. In patients under 45 years sensitivities and specificities of the 'office' test exceeded 90%. The two serological tests agreed in 87.5% of subjects.

Both tests performed satisfactorily. However, indeterminate results impaired the usefulness of the laboratory ELISA particularly when using a new cut-off. The 'office' ELISA performed particularly well in young patients. A simpler test using antigens from locally prevalent strains to optimise accuracy is awaited.