Evaluation of a novel monoclonal-based antigen-in-stool enzyme immunoassay (premier platinum HpSA plus) for diagnosis of Helicobacter pylori infection in Vietnamese children.
- Author:
Ha Thi Viet Nguyen
;
Khanh Gia Nguyen
;
Cam Dac Phung
- Publication Type:Journal Article
- Keywords:
Helicobacter pylori;
Anticorp monoclonal
- MeSH:
Helicobacter pylori/ pathogenicity;
Child
- From:Journal of Medical Research
2007;55(6):134-140
- CountryViet Nam
- Language:Vietnamese
-
Abstract:
Background: Helicobacter pylori infection is difficult to diagnose in children, especially in developing countries where non - invasive methods such as urea - breath test are often not available. Objectives: To evaluate the sensitivity and specificity of a new monoclonal antibody - based antigen - in - stool enzyme immunoassay (Premier Platinum HpSA PLUS) for diagnosis of H. pylori infection in Vietnamese children. Subjects and method: Sensitivity of the antigen - in - stool test was evaluated in 232 children, 3 - 15 years of age, who were positive for H. pylori infection by culture from biopsies. For evaluation of the specificity 241 children of similar age with non - gastrointestinal conditions were included with blood and stool samples. Results:Among the culture - positive children, 224 were also positive by Premier Platinum HpSA PLUS. Among the control children 98 had negative for H. pylori infection as established by serology, using two ELiSAs (in house and Pyloriset EIA - Gill) and an immunblot (Helicoblot 2.1). These 93 childrenhad H. pylori negative also in the stool test. The sensitivity, specificity, and positive and negative predictive values of Premier Platinum HpSA PLUS were thus found to be 96.6%, 94.9%, 97.8%, and 92.1 %, respectively. Conclusion: The outcome have demonstrated Premium Platinum HpSA PLUS to be a reliable method for detection of H. pylori infection in Vietnamese children.
