STOMACH Evaluation of a novel monoclonal enzyme immunoassay for detection of Helicobacter pylori antigen in stool from children
نویسندگان
چکیده
Background: Reliable non-invasive methods for detection of Helicobacter pylori infection are required to investigate the incidence, transmission, and clearance of infection in childhood. Aim: To evaluate a new monoclonal enzyme immunoassay (EIA) (FemtoLab H pylori Cnx) for detection of H pylori antigen in stool in a large cohort of children compared with invasive diagnostic methods and the C urea breath test. Patients and methods: A total of 302 symptomatic previously untreated children (aged 0.5–18.7 years; 148 girls) were recruited at three centres. H pylori status was defined by results of culture, histology, the rapid urease test, and the C urea breath test. Stool samples were investigated locally by the EIA using two different production lots. According to the manufacturer’s recommendations, an optical density (OD) of 0.150 was used as a cut off value. Results: OD values clearly differentiated between the 92 H pylori infected and the 210 non-infected children (median (5th–95th percentiles) 2.729 (0.232–>4.000) v 0.021 (0.009–0.075)). Only two false positive and two false negative results occurred, giving a sensitivity, specificity, positive predictive value, and negative predictive value of 98%, 99%, 98%, and 99%, respectively. No significant relation was found between age and OD values in infected or non-infected children. Conclusions: The monoclonal stool antigen EIA was excellent in diagnosing H pylori infection in symptomatic children. Accuracy was independent of the laboratory, production lot used, or the child’s age. Because only 18/116 children <6 years of age were infected with H pylori, further validation of the test is needed in young infected children.
منابع مشابه
Determination of Helicobacter pylori Antigen in Stool Samples and Comparison with Rapid Urease Test in Patients Suspected of Helicobacter Infection
Background and Aims: Helicobacter pylori (H. Pylori) is the microorganism that infects nearly half of word's population. There are several invasive and non-invasive methods for diagnosis of infection. The main objective of this study was to evaluate antigen of H. Pylori in feces with H. pylori stool antigen (HpSA) test and comparison with rapid urease test (RUT) in the patients suspected to be ...
متن کاملEvaluation of a novel monoclonal enzyme immunoassay for detection of Helicobacter pylori antigen in stool from children.
BACKGROUND Reliable non-invasive methods for detection of Helicobacter pylori infection are required to investigate the incidence, transmission, and clearance of infection in childhood. AIM To evaluate a new monoclonal enzyme immunoassay (EIA) (FemtoLab H pylori Cnx) for detection of H pylori antigen in stool in a large cohort of children compared with invasive diagnostic methods and the (13)...
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