title: Use of a receiver operating characteristic in the evaluation of two commercial enzyme immunoassays for detection of Helicobacter pylori infection.
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.
authors.affiliation: Department of Bacteriology, University of Ulm, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Trautmann
authors.forename: M
authors.initials: M
authors.lastname: Moldrzyk
authors.forename: K
authors.initials: K
authors.lastname: Vogt
authors.forename: J
authors.initials: J
authors.lastname: Körber
authors.forename: T
authors.initials: T
authors.lastname: Held
authors.forename: R
authors.initials: R
authors.lastname: Marre
mesh_terms: D000942:Antigens, Bacterial / Q000032:analysis; D015153:Blotting, Western; D016099:Endoscopy, Gastrointestinal; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000276:immunology; D016480:Helicobacter pylori / Q000276:immunology / Q000302:isolation & purification*; D006801:Humans; D007124:Immunoenzyme Techniques; D008875:Middle Aged; D011446:Prospective Studies; D012372:ROC Curve; D012680:Sensitivity and Specificity
chemical_list: D000942:Antigens, Bacterial