title: Multicenter comparison of rapid lateral flow stool antigen immunoassay and stool antigen enzyme immunoassay for the diagnosis of Helicobacter pylori infection in children.
abstract: OBJECTIVE
  The stool antigen enzyme immunoassay (EIA) methods are widely used for diagnosing Helicobacter pylori infection. Recently, a novel, rapid stool antigen test, the lateral flow immunoassay (LFI) method, has been developed. The primary purpose of this study was to compare the EIA method with the LFI method for the diagnosis of H. pylori infection in children.
  
  
  METHODS
  Stool specimens from children being evaluated for H. pylori infection were also examined using the LFI (ImmunoCard STAT! HpSA) and EIA methods (Premier Platinum HpSA). The sensitivity, specificity and accuracy of the test were based on the 13C-labeled urea breath test.
  
  
  RESULTS
  One hundred and eighty-two children and adolescents, 3-17 years of age (mean 9.2 years), were studied. In addition, 29 patients who received eradication therapy were re-evaluated 2 or 3 months post-treatment. The 13C-labeled urea breath test was positive in 64 patients (35.2%). The sensitivity, specificity and accuracy of the LFI method were 90.6% (95% CI = 80.7-96.5%), 95.8% (92.1-99.4%), and 94.0% (90.5-97.4%), respectively and for the EIA method, sensitivity, specificity and accuracy were 96.8% (95% CI, 89.0-99.6%) and 99.2% (97.5-100%), and 98.3% (96.5-100%), respectively. There were no significant differences in results among the age groups 3-5, 6-10 and 11-17 years. As for the assessment of H. pylori eradication, the results of the LFI and EIA methods agreed with those of 13C-urea breath test in 27/29 and 29/29 patients, respectively.
  
  
  CONCLUSIONS
  The LFI stool antigen method showed a good sensitivity, specificity and accuracy for diagnosing H. pylori infection in children. This novel method may be useful in clinical practice as an office-based test because it is rapid, reliable and easy to perform.
authors.affiliation: Department of Pediatrics, Tohoku University School of Medicine, Sendai, Japan. skato@ped.med.tohoku.ac.jp
authors.forename: Seiichi
authors.initials: S
authors.lastname: Kato
authors.forename: Kyoko
authors.initials: K
authors.lastname: Ozawa
authors.forename: Masumi
authors.initials: M
authors.lastname: Okuda
authors.forename: Yoshiko
authors.initials: Y
authors.lastname: Nakayama
authors.forename: Norikazu
authors.initials: N
authors.lastname: Yoshimura
authors.forename: Mutsuko
authors.initials: M
authors.lastname: Konno
authors.forename: Takanori
authors.initials: T
authors.lastname: Minoura
authors.forename: Kazuie
authors.initials: K
authors.lastname: Iinuma
mesh_terms: D000293:Adolescent; D000367:Age Factors; D000942:Antigens, Bacterial / Q000032:analysis*; D002648:Child; D002675:Child, Preschool; D005243:Feces / Q000382:microbiology*; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis*; D016480:Helicobacter pylori / Q000302:isolation & purification; D006801:Humans; D007118:Immunoassay; D007124:Immunoenzyme Techniques; D007564:Japan; D008297:Male; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D014510:Urease / Q000032:analysis
chemical_list: D000942:Antigens, Bacterial; D014510:Urease