Evaluation of a commercial serological kit for detection of salivary immunoglobulin G to Helicobacter pylori: a multicentre study

Eur J Gastroenterol Hepatol. 2000 Oct;12(10):1117-20. doi: 10.1097/00042737-200012100-00008.


Objective: To evaluate the usefulness of a commercial serological enzyme immunoassay (EIA) for detecting salivary immunoglobulin (Ig) G to Helicobacter pylori.

Design: Prospective, multicentre study.

Setting: The study was conducted at 11 gastroenterology hospital centres throughout Italy.

Participants and interventions: 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).

Main outcome measures: 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.

Conclusion: 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.

Publication types

  • Evaluation Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Female
  • Helicobacter Infections / diagnosis*
  • Helicobacter Infections / microbiology
  • Helicobacter pylori / immunology*
  • Helicobacter pylori / isolation & purification
  • Humans
  • Immunoenzyme Techniques / methods*
  • Immunoglobulin G / analysis*
  • Immunoglobulin G / blood
  • Male
  • Middle Aged
  • Predictive Value of Tests
  • Prospective Studies
  • ROC Curve
  • Saliva / immunology*
  • Sensitivity and Specificity
  • Serologic Tests


  • Immunoglobulin G