Evaluation of a novel monoclonal enzyme immunoassay for detection of Helicobacter pylori antigen in stool from children

• DOI: 10.1136/gut.52.6.804
• Publication Date: 2003-05-09T20:21:23Z
• Authors: S Koletzko
• Keywords: Male; Antigens, Bacterial; Adolescent; Helicobacter pylori; 610; Infant; Sensitivity and Specificity; Helicobacter Infections; 3. Good health; Immunoenzyme Techniques; Feces; 03 medical and health sciences; 0302 clinical medicine; Predictive Value of Tests; Child, Preschool; Humans; Female; Prospective Studies; Child

<b>Background:</b> Reliable non-invasive methods for detection of <i>Helicobacter pylori</i> infection are required to investigate the incidence, transmission, and clearance in childhood. <b>Aim:</b> To evaluate a new monoclonal enzyme immunoassay (EIA) (FemtoLab H pylori Cnx) <i>H antigen stool large cohort children compared with invasive diagnostic ¹³C urea breath test. <b>Patients methods:</b> A total 302 symptomatic previously untreated (aged 0.5–18.7 years; 148 girls) were recruited at three centres. status was defined by results culture, histology, rapid urease test, Stool samples investigated locally EIA using two different production lots. According manufacturer's recommendations, an optical density (OD) 0.150 used as cut off value. <b>Results:</b> OD values clearly differentiated between 92 infected 210 non-infected (median (5th–95th percentiles) 2.729 (0.232–&gt;4.000) <i>v</i> 0.021 (0.009–0.075)). Only false positive negative occurred, giving sensitivity, specificity, predictive value, value 98%, 99%, respectively. No significant relation found age or children. <b>Conclusions:</b> The excellent diagnosing Accuracy independent laboratory, lot used, child's age. Because only 18/116 &lt;6 years pylori</i>, further validation test is needed young