title: Usefulness of a novel enzyme immunoassay for the detection of Helicobacter pylori in feces.
abstract: BACKGROUND
  In this study we assessed the reliability of a newly developed enzyme immunoassay (HpSA) kit for detecting Helicobacter pylori antigen in stool.
  
  
  METHODS
  This study included 309 patients, 147 of whom were defined as positive and 162 as negative by the 13C-urea breath test, rapid urease test, and pathologic findings. From these patients fresh stool specimens were collected for HpSA.
  
  
  RESULTS
  When 0.100 was adopted as the cut-off value, in accordance with the manufacturer's recommendations, the sensitivity, specificity, and accuracy of the HpSA were 98.0%, 87.0%, and 92.2%, respectively. However, these values were much improved when a cut-off value of 0.300 was adopted, which was obtained with our receiver-operator characteristics curve; with this value the sensitivity, specificity, and accuracy of HpSA were 93.9%, 95.7%, and 94.8%, respectively.
  
  
  CONCLUSIONS
  These results indicate that HpSA is a highly reliable diagnostic method for H. pylori infection and is useful in confirming eradication.
authors.affiliation: Dept. of Gastroenterology, Juntendo University, School of Medicine, Tokyo, Japan.
authors.forename: R
authors.initials: R
authors.lastname: Ohkura
authors.forename: H
authors.initials: H
authors.lastname: Miwa
authors.forename: T
authors.initials: T
authors.lastname: Murai
authors.forename: A
authors.initials: A
authors.lastname: Nagahara
authors.forename: K
authors.initials: K
authors.lastname: Ohta
authors.forename: K
authors.initials: K
authors.lastname: Sato
authors.forename: T
authors.initials: T
authors.lastname: Yamada
authors.forename: N
authors.initials: N
authors.lastname: Sato
mesh_terms: D000942:Antigens, Bacterial / Q000032:analysis*; D005243:Feces / Q000382:microbiology*; D005260:Female; D016480:Helicobacter pylori / Q000276:immunology / Q000302:isolation & purification*; D006801:Humans; D007124:Immunoenzyme Techniques; D008297:Male; D008875:Middle Aged; D012372:ROC Curve; D012680:Sensitivity and Specificity
chemical_list: D000942:Antigens, Bacterial