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Updated: Oct 20, 2026

Rapid Detection of Fecal Antigen of Helicobacter pylori Infection Based on Double Antibody Sandwich Detection Technology
Published on: May 23, 2025
Validation and value of an enzyme-linked immunosorbent assay for Helicobacter pylori in primary care
N T Lewin-van den Broek1, M E Numans, E Buskens
1Dept. of General Practice, and Julius Center for Patient Oriented Research, Faculty of Medicine, University of Utrecht, University Hospital, The Netherlands.
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.
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Enzyme-Linked Immunosorbent Assay
There are many different types of ELISAs, but they all involve an antibody molecule whose constant region binds an enzyme, leaving the variable region free to bind its specific antigen. Enzyme-substrate reaction allows the antigen to be visualized or quantified.
Peptic Ulcer