title: [Performance of current infection marker test for the diagnosis of Helicobacter pylori current infection: a multicenter clinical trial].
abstract: OBJECTIVE
  To evaluate the performance of the ASSURE(TM) Helicobacter pylori (H. pylori) rapid test [current infection marker (CIM) kit, Genelabs Diagnostics] in detecting the current infection marker CIM for the diagnosis of H. pylori in adult patients.
  
  
  METHODS
  For this multicenter and controlled clinical trial, a total of 300 patients with an average age of (41 ± 16) years old were recruited from 7 participating hospitals. There were 128 men and 172 women, never received any H. pylori eradication therapy. Each subject received a (13)C-urea breath test ((13)C-UBT) and a CIM test. Such performance parameters as sensitivity, specificity, positive and negative predictive values and accuracy were determined by (13)C-UBT for the diagnosis of current H. pylori infection.
  
  
  RESULTS
  According to the gold standard, there were 131 positive and 169 negative subjects. The accuracy rate, sensitivity, specificity, positive and negative predictive values of CIM test were 89.0% (267/300), 87.8% (115/131), 89.9% (152/169), 87.1% (115/132) and 90.5% (152/168) respectively.
  
  
  CONCLUSIONS
  As a simple, rapid, accurate and affordable assay, CIM test may be useful for a non-invasive diagnosis of H. pylori infection in cases without eradication therapy.
mesh_terms: D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood*; D001944:Breath Tests; D005260:Female; D016481:Helicobacter Infections / Q000097:blood / Q000175:diagnosis*; D016480:Helicobacter pylori / Q000276:immunology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D012698:Serologic Tests
chemical_list: D000907:Antibodies, Bacterial; D011933:Reagent Kits, Diagnostic