title: Real-time detection of Helicobacter Pylori infection and atrophic gastritis: comparison between conventional methods and a novel device for gastric juice analysis during endoscopy.
abstract: OBJECTIVE
  Gastric juice may represent a valuable source of clinicopathological information if properly analyzed. We evaluated the reliability and clinical validity of data obtained using an innovative device (the "Mt 21-42") that analyzes gastric juice, thus allowing the identification of Helicobacter pylori infection and atrophic gastritis of the oxyntic mucosa during endoscopy.
  
  
  METHODS
  Validation studies were carried out to evaluate the measuring performance of the device. In addition, the H. pylori status and the presence of atrophic gastritis were assessed in 150 patients undergoing upper gastrointestinal endoscopy. In all these patients the Mt 21-42 device was used to assist endoscopy. Conventional tests (involving histology, urease testing, urea breath testing, anti- H. pylori IgG, serum gastrin, pepsinogen, intrinsic factor and parietal cells autoantibodies, vitamin B12, and folate) were also performed for comparison with the Mt 21-42 results.
  
  
  RESULTS
  The measuring performance of the Mt 21-42 was good; for pH, the relative percent error and the coefficient of variation were 1.9 % +/- 4.2 and 1.3 %, respectively, and for ammonium they were 0.1 % +/- 0.2 % and 2.1 %. For the detection of H. pylori infection, the sensitivity and specificity of the device (96.7 % and 94.3 %) were similar to those of the urea breath test (90.5 % and 93.3 %) and serology (87.1 % and 88.8 %), and higher than those of the urease test (78.6 % and 98.7 %; P < 0.01) and routine histology (94.3 % and 76.3 %; P < 0.05). When compared with the currently available standard methods, use of the Mt 21-42 was found to be the most sensitive technique for the detection of atrophy (94.7 % vs. 5.3 % - 47.4 %; P < 0.001); the device failed to detect the disease in only one case (5 %), whereas failure rates of 53 % - 95 % were reported with the conventional methods.
  
  
  CONCLUSIONS
  Atrophic gastritis of the oxyntic mucosa is a risky condition that often goes undetected in current clinical practice. The Mt 21-42 is an effective, useful, and desirable tool that may help to overcome this diagnostic limitation; it produces time and cost savings and also allows the detection of H. pylori infection.
authors.affiliation: Gastrointestinal Unit, University of Bologna, AUSL of Imola, Castel S. Pietro Terme Hospital, Italy. tucciant@tin.it
authors.forename: A
authors.initials: A
authors.lastname: Tucci
authors.forename: P
authors.initials: P
authors.lastname: Tucci
authors.forename: M
authors.initials: M
authors.lastname: Bisceglia
authors.forename: A
authors.initials: A
authors.lastname: Marchegiani
authors.forename: G
authors.initials: G
authors.lastname: Papadopoli
authors.forename: P
authors.initials: P
authors.lastname: Fusaroli
authors.forename: A
authors.initials: A
authors.lastname: Spada
authors.forename: M O
authors.initials: MO
authors.lastname: Pistoletto
authors.forename: M O
authors.initials: MO
authors.lastname: Pistoletto
authors.forename: M
authors.initials: M
authors.lastname: Cristino
authors.forename: L
authors.initials: L
authors.lastname: Poli
authors.forename: A
authors.initials: A
authors.lastname: Villani
authors.forename: M
authors.initials: M
authors.lastname: Bucci
authors.forename: M
authors.initials: M
authors.lastname: Marinelli
authors.forename: G
authors.initials: G
authors.lastname: Caletti
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001706:Biopsy; D003937:Diagnosis, Differential; D020776:Endoscopes, Gastrointestinal; D016099:Endoscopy, Gastrointestinal / Q000379:methods*; D004867:Equipment Design; D005260:Female; D005750:Gastric Juice / Q000737:chemistry* / Q000382:microbiology; D005753:Gastric Mucosa / Q000473:pathology; D005757:Gastritis, Atrophic / Q000175:diagnosis* / Q000378:metabolism; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000378:metabolism; D016480:Helicobacter pylori / Q000378:metabolism*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D066298:In Vitro Techniques; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D000644:Quaternary Ammonium Compounds / Q000032:analysis*; D015203:Reproducibility of Results; D012189:Retrospective Studies; D014510:Urease / Q000032:analysis*
chemical_list: D000644:Quaternary Ammonium Compounds; D014510:Urease