title: Comparison of a new office-based stool immunoassay and (13)C-UBT in the diagnosis of current Helicobacter pylori infection.
abstract: Noninvasive methods to diagnose the infection status of Helicobacter pylori were a new developed trend. In this study, the authors sought to investigate the difference between a new office-based stool immunoassay (ImmunoCard STAT! HpSA) and (13)C-Urea Breath Test ((13)C-UBT). We studied 254 dyspeptic patients (159 men, 95 women; mean age=52.8 +/- 14.3 years, range: 19--89 years). All of them underwent gastroendoscopy, (13)C-UBT test, and delivered stool samples within 3 days after endoscopy for the ImmunoCard STAT! HpSA test. The exclusion criteria were those who (1) had received previous anti-Hp treatment, proton pump inhibitor, antibiotics, or bismuth within 1 month of endoscopic examination; (2) had bleeding peptic ulcers; (3) had previously undergone gastric surgery; (4) had long-term use of corticosteroid or immunosuppressant drugs; (5) were pregnant or lactating; and (6) had incomplete data. Hp infection was considered positive when either culture was positive, or both histology and rapid urea test were positive. Those patients were classified as pre- and post-Hp treatment groups. Those in the post-treatment group were patients who received Hp eradication therapy at our hospital more than 2 months ago. The overall sensitivity, specificity, and positive and negative predictive values of (13)C-UBT and ImmunoCard STAT! HpSA were 96.3%, 87.6%, 85.4%, 96.9%, and 95.4%, 83.4%, 81.3%, 96.0%, respectively. The sensitivity, specificity, and accuracy of both tests are comparable in the pre- and post- treatment groups. The advantages of ImmunoCard STAT! HpSA over a breath test are that it is cheaper, more time-saving, and can be used in-office.
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Clinical Pathology, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
authors.forename: I-Chen
authors.initials: IC
authors.lastname: Wu
authors.forename: Sheng-Wen
authors.initials: SW
authors.lastname: Wang
authors.forename: Yuan-Chieh
authors.initials: YC
authors.lastname: Yang
authors.forename: Fang-Jung
authors.initials: FJ
authors.lastname: Yu
authors.forename: Chao-Hung
authors.initials: CH
authors.lastname: Kuo
authors.forename: Chieh-Han
authors.initials: CH
authors.lastname: Chuang
authors.forename: Yi-Chen
authors.initials: YC
authors.lastname: Lee
authors.forename: Hung-Lung
authors.initials: HL
authors.lastname: Ke
authors.forename: Fu-Chen
authors.initials: FC
authors.lastname: Kuo
authors.forename: Lin-Li
authors.initials: LL
authors.lastname: Chang
authors.forename: Wen-Ming
authors.initials: WM
authors.lastname: Wang
authors.forename: Chang-Ming
authors.initials: CM
authors.lastname: Jan
authors.forename: Deng-Chyang
authors.initials: DC
authors.lastname: Wu
mesh_terms: D000328:Adult; D001944:Breath Tests; D002247:Carbon Isotopes; D003710:Demography; D004415:Dyspepsia; D005243:Feces / Q000382:microbiology*; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011933:Reagent Kits, Diagnostic; D012015:Reference Standards; D014508:Urea
chemical_list: D002247:Carbon Isotopes; D011933:Reagent Kits, Diagnostic; D014508:Urea