Use of a receiver operating characteristic in the evaluation of two commercial enzyme immunoassays for detection of Helicobacter pylori infection

Eur J Clin Microbiol Infect Dis. 1994 Oct;13(10):812-9. doi: 10.1007/BF02111341.

Abstract

Two novel commercial IgG enzyme immunoassay (EIA) systems based on acid-glycine-extracted (Pyloriset IgG EIA, Orion Diagnostica) or fast protein liquid chromatography-purified (Cobas Core Anti-H. pylori EIA, Roche Diagnostic Systems) Helicobacter antigens were evaluated in a prospective study involving 127 patients. All patients underwent upper endoscopy with biopsy, and biopsies were examined for the presence of Helicobacter pylori by a rapid urease test, microscopy and culture. Of the 71 patients found to be infected with Helicobacter pylori, 69 (97.2%) and 65 (91.5%) tested positive with the Cobas Core and Pyloriset test, respectively. A detailed receiver operating characteristic analysis of the two tests showed that the Cobas Core assay was more sensitive and specific at every possible cut-off level; gave a better resolution of individual results, indicating a greater fine-sensitivity; and had no grey zone compared to a large grey zone encompassing 13.4% of the serum samples tested with the Pyloriset EIA. The Cobas Core assay appears to be a valuable tool for epidemiological purposes as well as for pre-endoscopic screening of dyspeptic patients.

Publication types

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

MeSH terms

  • Antigens, Bacterial / analysis
  • Blotting, Western
  • Endoscopy, Gastrointestinal
  • Helicobacter Infections / diagnosis*
  • Helicobacter Infections / immunology
  • Helicobacter pylori / immunology
  • Helicobacter pylori / isolation & purification*
  • Humans
  • Immunoenzyme Techniques*
  • Middle Aged
  • Prospective Studies
  • ROC Curve
  • Sensitivity and Specificity

Substances

  • Antigens, Bacterial