title: Evaluation of a newly developed office-based stool test for detecting Helicobacter pylori: an extensive pilot study.
abstract: OBJECTIVE
  Several strategies have been used to detect Helicobacter pylori (Hp) infection along two lines: 1) direct detection of the bacteria, and 2) detection of antigen-antibody assay against Hp. The non-invasive methods include ELISA test of serum, salivary and urine, urea breath test, and detection of Hp antigen in stool. The latter method (HpSA) has been proven reliable and better than the ELISA test, for it can detect current Hp infection and is suitable for post-treatment follow-up. Now, a new commercial kit, ImmunoCard STAT HpSA (Meridian Bioscience Europe) has been developed to detect stool Hp antigen. It is simpler and less time-consuming than HpSA. The aim was to examine whether ImmunoCard STAT HpSA is qualified for diagnosis of Hp infection.
  
  
  METHODS
  253 patients (163 men, 90 women, mean age: 53.3 +/- 13.9 y/o, range: 19-89 y/o) were enrolled in this study. All of them had undergone gastroendoscopy and urea breath test. 207 patients were diagnosed with peptic ulcer and 46 with gastritis. Stool samples were collected within 3 days of their visit for gastroendoscopy and were sent for the Immunocard test.
  
  
  RESULTS
  118 patients were diagnosed with Hp infection and of these, 113 were interpreted as positive by means of the Immunocard test. Among the other 135 patients without Hp infections, 123 were interpreted as negative by means of the Immunocard test. Sensitivity and specificity were 95.8% and 91.1%, and positive and negative predictive values were 90.4% and 96.1%.
  
  
  CONCLUSIONS
  The ImmunoCard STAT HpSA had high sensitivity, and specificity and could be used for mass screening. We concluded that it is a rapid, simple, cheap, reliable, and non-invasive strategy to detect current Hp infection and can be used in post-Hp eradication follow-up in Taiwan.
authors.affiliation: Department of Internal Medicine, Kaohsiung Medical University Hospital, 100 Shih-Chuan, 1st Road, Kaohsiung City, 807, Taiwan.
authors.forename: I-Chen
authors.initials: IC
authors.lastname: Wu
authors.forename: Hung-Lung
authors.initials: HL
authors.lastname: Ke
authors.forename: Yi-Ching
authors.initials: YC
authors.lastname: Lo
authors.forename: Yuan-Chieh
authors.initials: YC
authors.lastname: Yang
authors.forename: Chieh-Han
authors.initials: CH
authors.lastname: Chuang
authors.forename: Fang-Jung
authors.initials: FJ
authors.lastname: Yu
authors.forename: Yi-Chen
authors.initials: YC
authors.lastname: Lee
authors.forename: Chang-Ming
authors.initials: CM
authors.lastname: Jan
authors.forename: Wen-Ming
authors.initials: WM
authors.lastname: Wang
authors.forename: Deng-Chyang
authors.initials: DC
authors.lastname: Wu
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000942:Antigens, Bacterial / Q000032:analysis*; D005243:Feces / Q000737:chemistry; D005260:Female; D005756:Gastritis / Q000175:diagnosis* / Q000276:immunology / Q000382:microbiology; D005773:Gastroscopy; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000276:immunology / Q000382:microbiology; D016480:Helicobacter pylori / Q000276:immunology*; D006801:Humans; D008297:Male; D008403:Mass Screening; D008875:Middle Aged; D010437:Peptic Ulcer / Q000175:diagnosis* / Q000276:immunology / Q000382:microbiology; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic
chemical_list: D000942:Antigens, Bacterial; D011933:Reagent Kits, Diagnostic