Validation and value of an enzyme-linked immunosorbent assay for Helicobacter pylori in primary care

Abstract

Background: Helicobacter pylori infection is related to gastric ulcer and carcinoma. In this study we validated the Pyloriset EIA-G New (a quantitative enzyme-linked immunosorbent assay) in a general practice population. The implications of eradication in case of a positive result were assessed.

Methods: One hundred and fifteen subsequent patients, enrolled in a randomized clinical trial evaluating the optimal strategy for treatment of dyspeptic patients in primary care, were included. Using biopsy as gold standard, we calculated the sensitivity and specificity of the test.

Results: The sensitivity and specificity of the test were 91% (95% confidence interval (CI) = 86% to 97%) and 78% (95% CI = 75% to 82%), respectively. Eradication of H. pylori would be indicated in 8 of 57 positive patients, since these actually had a peptic ulcer. In the other 49 patients eradication therapy would be unnecessary.

Conclusion: The Pyloriset EIA-G New is a reliable test in primary care. However, a serologic test-and-treat strategy in all dyspeptic patients cannot be recommended.