BACKGROUND: 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. AIMS: This study examined the performance of a laboratory and 'office' ELISA in a population of Irish dyspeptics presenting for endoscopy. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
BACKGROUND: 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. AIMS: This study examined the performance of a laboratory and 'office' ELISA in a population of Irish dyspeptics presenting for endoscopy. METHODS: 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. pyloriinfection 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. RESULTS: 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. CONCLUSIONS: 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.