New immunoassay for the detection of Helicobacter pylori infection compared with urease test, 13C breath test and histology: Validation in the primary care setting

Helicobacter pylori plays a major role in peptic ulcer disease and, as a result, testing for H. pylori infection among patients with dyspepsia has often been advocated. The aim of the study was to determine the diagnostic accuracy, the analytical performance, and optimal cut-off point of a new serological assay, the Pyloriset® EIA-G III for the detection of H. pylori infection in the primary care setting. For 113 primary care patients with dyspepsia urea breath test, CLO™ test, histology and serology tests were performed. Diagnostic accuracy of the Pyloriset® EIA-G III was evaluated against a reference standard of a carbon urea breath test (CUBT), CLO™ test and histology (from gastric biopsies). Precision, linearity and correlation of the serological assay with the CUBT and former Pyloriset® were also determined. At the optimal cut-off level of 40 U/ml, the positive predictive value was 92.1%, negative predictive value 96.3%, sensitivity 87.5%, and specificity 93.9%. The within-run precision was high. The recovery data were good. The correlation of both CUBT and the former Pyloriset® EIA-G and the Pyloriset® EIA-G III was high. At the cut-off level of 40 U/ml, the new Pyloriset® EIA-G III is a reliable method to detect H. pylori infection in the primary care setting.