Z Gastroenterol 2016; 54 - P37
DOI: 10.1055/s-0036-1584015

Evaluation of a rapid whole-blood immunoassay to detect IgG antibodies against Helicobacter pylori

D Enko 1, G Halwachs-Baumann 1, R Stolba 1, O Rössler 2, G Kriegshäuser 1
  • 1Institute of Clinical Chemistry and Laboratory Medicine, General Hospital Steyr, Steyr, Austria
  • 2Institute of Pathology, General Hospital Steyr, Steyr, Austria

Introduction: Since individuals infected with H. pylori develop a local and systemic immune response, several diagnostic manufacturers have launched rapid H. pylori antibody tests. However, some of these tests are often used without sufficient evaluation. The purpose of this study was to compare the clinical performance of a commercially available rapid whole-blood immunoassay (gabControl® H. pylori [gabmed GmbH, Köln, Germany]) for the qualitative detection of IgG antibodies against H. pylori with the 13C-urea breath test (13C-UBT) serving as a reference method.

Patients and Methods: In total 108 outpatients, who were referred for the 13C-UBT, were also tested for H. pylori infection by the gabControl® H. pylori immunoassay. The inclusion criteria were a minimum age of > 15 years, an overnight fasting state and a non-smoking period > 12h before the 13C-UBT. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the gabControl® H. pylori immunoassay were calculated compared to the 13C-UBT.

Results: With the 13C-UBT serving as the non-invasive gold standard method of H. pylori diagnosis, the gabControl® H. pylori assay demonstrated a sensitivity and specificity of 91.4% and 76.7%, respectively, with a PPV of 65.3% and a NPV of 94.9%. Seventeen (15.7%) individuals with a positive H. pylori anamnesis showed a negative 13C-UBT and were typed positive by the gabControl® H. pylori assay. Of these, 13 (76.5%) and 3 individuals (17.6%) had completed one and two eradication therapies, respectively.

Conclusions: In daily clinical practice the gabControl® H. pylori immunoassay is a rapid and easy to use first line screening tool for H. pylori IgG antibody detection. However, this assay should not be used for confirmation of the successful H. pylori eradication after antibiotic treatment.