title: Accuracy of a new near patient test for the diagnosis of Helicobacter pylori infection in Chinese.
abstract: OBJECTIVE
  The performance of existing near patient tests for the diagnosis of Helicobacter pylori remains unsatisfactory. The aim of this study is to evaluate the accuracy of a new near patient test (Signify H. pylori) for the diagnosis of H. pylori and the usefulness of the Signify H. pylori test for a test and treat strategy.
  
  
  METHODS
  Consecutive dyspeptic patients referred for upper endoscopy were recruited. Rapid urease test and histology were used as the gold standard. After endoscopy, blood was collected for the Signify H. pylori test and compared with a gold standard.
  
  
  RESULTS
  Two hundred and forty-four patients were eligible for analysis and 121 (49.5%) were positive for H. pylori. The Signify H. pylori test showed a sensitivity, specificity, and accuracy of 84.3, 89.4%, and 86.9%, respectively, for whole blood and 79.3, 88.6, and 84.0% for serum, respectively. The sensitivity and specificity of the Signify H. pylori whole blood test was 87.5 and 92.6% for patients less than 45-years-old and the accuracy was similar between patients referred from primary care physicians or gastroenterologists. The test is easy to operate and results are available within 5 min.
  
  
  CONCLUSIONS
  The Signify H. pylori test is accurate for the near patient diagnosis of H. pylori infection.
authors.affiliation: Department of Medicine, University of Hong Kong, Queen Mary Hospital, Hong Kong.
authors.forename: Wai Man
authors.initials: WM
authors.lastname: Wong
authors.forename: Shiu Kum
authors.initials: SK
authors.lastname: Lam
authors.forename: Harry H X
authors.initials: HH
authors.lastname: Xia
authors.forename: Vera Sy
authors.initials: VS
authors.lastname: Tang
authors.forename: Kam Chuen
authors.initials: KC
authors.lastname: Lai
authors.forename: Wayne H C
authors.initials: WH
authors.lastname: Hu
authors.forename: Chi Kuen
authors.initials: CK
authors.lastname: Chan
authors.forename: Kwan Lok
authors.initials: KL
authors.lastname: Cheung
authors.forename: Benjamin C Y
authors.initials: BC
authors.lastname: Wong
mesh_terms: D000328:Adult; D001706:Biopsy; D002681:China / Q000453:epidemiology; D005260:Female; D005753:Gastric Mucosa / Q000382:microbiology; D005773:Gastroscopy; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000453:epidemiology; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D012680:Sensitivity and Specificity; D014510:Urease / Q000378:metabolism
chemical_list: D014510:Urease