title: Performance of a one-step fecal sample-based test for diagnosis of Helicobacter pylori infection in primary care and mass screening settings.
abstract: OBJECTIVE
  An alternative screening test is needed to efficiently eradicate Helicobacter pylori from a population with prevalent upper gastrointestinal lesions. We evaluated the performance of a new one-step fecal test for H. pylori for diagnosis of H. pylori infection in Taiwan.
  
  
  METHODS
  We developed a fecal test to detect H. pylori based on the immunochronomatographic assay and a mixture of monoclonal antibodies. We first recruited symptomatic patients from the primary care setting to evaluate fecal test performance using a reference standard consisting of (13)C urea breath test, rapid urease test, and histology. We also compared the performance of the fecal test with that of others. Next, we recruited asymptomatic participants from the mass screening setting to evaluate population attendance for the fecal test and compared its performance with that of (13)C urea breath test.
  
  
  RESULTS
  In the primary care setting, 117 patients were recruited; H. pylori infection was confirmed in 58 (49.6%). Fecal test sensitivity, specificity, positive and negative predictive values, and accuracy were 88.0% [95% confidence interval (CI): 79.6-96.4%], 100%, 100%, 89.4% (95% CI, 82.0-96.8%), and 94% (95% CI, 89.7-98.3%), respectively. Fecal test specificity and positive predictive value were significantly higher than those of the serological test, whereas the sensitivity and negative predictive value were lower than those of the (13)C urea breath test (p < 0.05). In the mass screening setting, 2720 of 3520 invited individuals participated (77.3%; 95% CI, 76-78.7%); 649 (23.9%) showed positive results. Concordance rate and kappa statistic between the fecal test and (13)C urea breath test were 91.7% (563/614; 95% CI, 89.9-94.1%) and 0.78 (95% CI, 0.73-0.84), respectively.
  
  
  CONCLUSIONS
  Given the acceptable sensitivity, excellent specificity, and high participation rate to screening, the one-step H. pylori stool antigen test is feasible for wide application in the community.
authors.affiliation: Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan; Division of Biostatistics, Graduate Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan.
authors.forename: Yi-Chia
authors.initials: YC
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan.
authors.forename: Ping-Huei
authors.initials: PH
authors.lastname: Tseng
authors.affiliation: Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan.
authors.forename: Jyh-Ming
authors.initials: JM
authors.lastname: Liou
authors.affiliation: Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan; Department of Integrated Diagnostic & Therapeutics, National Taiwan University Hospital, Taipei, Taiwan.
authors.forename: Mei-Jyh
authors.initials: MJ
authors.lastname: Chen
authors.affiliation: Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan.
authors.forename: Chien-Chuan
authors.initials: CC
authors.lastname: Chen
authors.affiliation: Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan.
authors.forename: Chia-Hung
authors.initials: CH
authors.lastname: Tu
authors.affiliation: Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan; Department of Integrated Diagnostic & Therapeutics, National Taiwan University Hospital, Taipei, Taiwan.
authors.forename: Tsung-Hsien
authors.initials: TH
authors.lastname: Chiang
authors.affiliation: Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan.
authors.forename: Han-Mo
authors.initials: HM
authors.lastname: Chiu
authors.affiliation: Research and Development, Firstep Bioresearch Incorporation, Tainan, Taiwan.
authors.forename: Chien-Fang
authors.initials: CF
authors.lastname: Lai
authors.affiliation: Research and Development, Firstep Bioresearch Incorporation, Tainan, Taiwan.
authors.forename: Jhon-Chun
authors.initials: JC
authors.lastname: Ho
authors.affiliation: Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan; Department of Primary Care Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan. Electronic address: mingshiang@ntu.edu.tw.
authors.forename: Ming-Shiang
authors.initials: MS
authors.lastname: Wu
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal; D000942:Antigens, Bacterial / Q000032:analysis*; D001944:Breath Tests; D005243:Feces / Q000382:microbiology*; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis*; D016480:Helicobacter pylori / Q000276:immunology*; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D011237:Predictive Value of Tests; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D000942:Antigens, Bacterial
keywords: Helicobacter pylori; mass screening; stool antigen test