title: Evaluation of a novel monoclonal-based antigen-in-stool enzyme immunoassay (Premier Platinum HpSA PLUS) for diagnosis of Helicobacter pylori infection in Vietnamese children.
abstract: BACKGROUND
  Helicobacter pylori infection is difficult to diagnose in children, especially in developing countries where noninvasive methods such as urea breath test are often not available. We 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.
  
  
  METHODS
  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 98 children of similar age with nongastrointestinal conditions and who were negative for H. pylori infection by serologic assays were included with blood and stool samples.
  
  
  RESULTS
  Of the 232 culture-positive children, 224 were also positive by Premier Platinum HpSA PLUS. Of the 98 control children, 93 were H. pylori negative also in the stool test. The sensitivity of Premier Platinum HpSA PLUS was thus 96.6% (95% CI 93.3-98.5) and the specificity was 94.9% (95% CI 88.5-98.3).
  
  
  CONCLUSIONS
  The findings have demonstrated Premium Platinum HpSA PLUS to be a reliable method for detection of H. pylori infection also in children in our area.
authors.affiliation: Unit of Clinical Microbiology, Department of Microbiology, Tumor and Cell Biology (MTC), Karolinska Institutet and Clinical Microbiology, Karolinska University Hospital, Solna, Sweden.
authors.forename: Thi Viet Ha
authors.initials: TV
authors.lastname: Nguyen
authors.forename: Carina
authors.initials: C
authors.lastname: Bengtsson
authors.forename: Gia Khanh
authors.initials: GK
authors.lastname: Nguyen
authors.forename: Marta
authors.initials: M
authors.lastname: Granström
mesh_terms: D000293:Adolescent; D000907:Antibodies, Bacterial / Q000032:analysis* / Q000276:immunology; D000911:Antibodies, Monoclonal / Q000032:analysis* / Q000276:immunology; D000942:Antigens, Bacterial / Q000032:analysis / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005243:Feces / Q000382:microbiology; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000276:immunology / Q000382:microbiology; D016480:Helicobacter pylori / Q000276:immunology / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D012680:Sensitivity and Specificity; D014744:Vietnam
chemical_list: D000907:Antibodies, Bacterial; D000911:Antibodies, Monoclonal; D000942:Antigens, Bacterial