title: Evaluation of a commercial serological kit for detection of salivary immunoglobulin G to Helicobacter pylori: a multicentre study.
abstract: OBJECTIVE
  To evaluate the usefulness of a commercial serological enzyme immunoassay (EIA) for detecting salivary immunoglobulin (Ig) G to Helicobacter pylori.
  
  
  METHODS
  Prospective, multicentre study.
  
  
  METHODS
  The study was conducted at 11 gastroenterology hospital centres throughout Italy.
  
  
  METHODS
  Two hundred and thirteen dyspeptic patients underwent gastroscopy with antral biopsies. At each centre, two of the following three tests for H. pylori diagnosis were performed: urease quick test, histology, and 13C-urea breath test. Samples of unstimulated saliva and venous blood were collected from each patient. Salivary and serum H. pylori IgG were determined with the EIA Helori-test IgG (Eurospital, Trieste, Italy).
  
  
  METHODS
  Sensitivity, specificity, positive and negative predictive values, and accuracy of the salivary and serum EIAs.
  
  
  RESULTS
  By using a receiver operating characteristic curve, salivary EIA yielded 81% (95% confidence interval 73-87%) sensitivity, 73% (62-83%) specificity, 84% (76-90%) positive predictive value, 69% (58-79%) negative predictive value, and 78% (72-84%) accuracy. At the cut-off suggested by the manufacturer, serum EIA had 90% (84-95%) sensitivity, 78% (67-86%) specificity, 88% (81-93%) positive predictive value, 82% (71-90%) negative predictive value, and 86% (81-91%) accuracy.
  
  
  CONCLUSIONS
  In this large multicentre study, detection of salivary H. pylori IgG with a commercial serological EIA was a fairly accurate diagnostic method. Data confirm that saliva testing does not compare favourably with serology in the assessment of H. pylori status.
authors.affiliation: Dipartimento di Medicina Sperimentale e Clinica, Università di Catanzaro Magna Graecia, Catanzaro, Italy. luzza@unicz.it
authors.forename: F
authors.initials: F
authors.lastname: Luzza
authors.forename: M
authors.initials: M
authors.lastname: Imeneo
authors.forename: A
authors.initials: A
authors.lastname: Marasco
authors.forename: S
authors.initials: S
authors.lastname: Crotta
authors.forename: E
authors.initials: E
authors.lastname: Ierardi
authors.forename: P
authors.initials: P
authors.lastname: Usai
authors.forename: C
authors.initials: C
authors.lastname: Virgilio
authors.forename: G
authors.initials: G
authors.lastname: Nardone
authors.forename: S
authors.initials: S
authors.lastname: Marchi
authors.forename: G
authors.initials: G
authors.lastname: Sanna
authors.forename: F
authors.initials: F
authors.lastname: Perri
authors.forename: R
authors.initials: R
authors.lastname: Maurizio Zagari
authors.forename: F
authors.initials: F
authors.lastname: Bazzoli
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000382:microbiology; D016480:Helicobacter pylori / Q000276:immunology* / Q000302:isolation & purification; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods*; D007074:Immunoglobulin G / Q000032:analysis* / Q000097:blood; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012372:ROC Curve; D012463:Saliva / Q000276:immunology*; D012680:Sensitivity and Specificity; D012698:Serologic Tests
chemical_list: D007074:Immunoglobulin G