title: A new simple immunoassay for detecting Helicobacter pylori infection: antigen in stool specimens.
abstract: OBJECTIVE
  Several diagnostic tests are available for evaluating Helicobacter pylori (Hp) infection: histological examination, culture of gastric biopsy specimens, rapid urease test, urea breath test and serology. A recently marketed direct enzyme immunoassay (HpSA) detects Hp antigen in stool samples. The aim of our study was to evaluate overall diagnostic sensitivity, specificity and positive and negative predictive values of this new diagnostic test.
  
  
  METHODS
  We included in the study 84 patients (39 males and 45 females; mean age 49.57 years) with dyspeptic symptoms who were examined by upper gastrointestinal endoscopy. Exclusion criteria were previous treatment with proton pump inhibitors, bismuth compounds or antibiotics. During the endoscopic examination biopsies were taken from antrum and corpus for Hp culture and histological examination, and stool specimens were submitted to the laboratory to be stored until the HpSA test. Hp was judged to be present when culture or histology and culture were positive. The (13)C-urea breath test was done only in culture-negative patients in whom either histology or immunoassay or both were positive.
  
  
  RESULTS
  Hp was found in 55 patients by both culture and histology. Stool antigen has been detected in 54 of the 55 Hp-positive patients, giving a sensitivity of 98.2% and a negative predictive value of 96.4%. In 2 out of 29 patients HpSA gave a positive result, but the biopsy-based methods were negative, resulting in a low rate of false-positives, with 93.1% specificity and 96.4% positive predictive value; the (13)C-urea breath test confirmed these results as negative.
  
  
  CONCLUSIONS
  Our results show that this new test is highly sensitive and specific for the detection of Hp infection, and it is satisfactorily reproducible.
authors.affiliation: Gastroenterology, San Raffaele Hospital, Milan, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Fanti
authors.forename: G
authors.initials: G
authors.lastname: Mezzi
authors.forename: A
authors.initials: A
authors.lastname: Cavallero
authors.forename: G
authors.initials: G
authors.lastname: Gesu
authors.forename: C
authors.initials: C
authors.lastname: Bonato
authors.forename: E
authors.initials: E
authors.lastname: Masci
mesh_terms: D000328:Adult; D000368:Aged; D000942:Antigens, Bacterial / Q000032:analysis*; D001944:Breath Tests; D005069:Evaluation Studies as Topic; D005243:Feces / Q000382:microbiology*; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis*; D016480:Helicobacter pylori / Q000276:immunology*; D006801:Humans; D007124:Immunoenzyme Techniques; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D000942:Antigens, Bacterial