Abstract
BackgroundA growing number of rapid Helicobacter pylori antibody tests are commercially available now, however, some of these tests are often used without sufficient evaluation. The aim of this study was to evaluate the 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.MethodsA total of 108 consecutive outpatients, who were referred for 13C-UBT by general practitioners and specialists, were also tested for H. pylori infection by the gabControl®H. pylori immunoassay. The clinical performance of this rapid whole-blood test was evaluated by determining the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) compared to the 13C-UBT. The agreement between the two tests was calculated using Cohen’s Kappa (κ) with 95 % confidence intervals (CI).ResultsThe agreement between the gabControl®H. pylori assay and the 13C-UBT was 0.62 [95 % confidence intervals (CIs) 0.47–0.76; P < 0.001]. 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.ConclusionsThe gabControl®H. pylori immunoassay is a rapid and easy to use first line screening tool for H. pylori IgG antibody detection in daily clinical practice. However, this assay should not be used for confirmation of the successful H. pylori eradication after antibiotic treatment.
Highlights
A growing number of rapid Helicobacter pylori antibody tests are commercially available some of these tests are often used without sufficient evaluation
Since the H. pylori infection was recognized as a causative agent of chronic active gastritis and a risk factor for ulcer disease, gastric cancer and the mucosa-associated lymphoid tissue (MALT) lymphoma, numerous invasive and non-invasive methods for the accurate detection of this bacterium have been developed
The aim of this study was to evaluate the performance of a commercially available rapid whole blood immunoassay, for the qualitative detection of IgG antibodies against H. pylori with the 13C-urea breath test (13C-UBT) serving as a reference method
Summary
A growing number of rapid Helicobacter pylori antibody tests are commercially available some of these tests are often used without sufficient evaluation. The aim of this study was to evaluate the perfor‐ mance 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) serv‐ ing as a reference method. The 13C-UBT is considered the non-invasive gold standard method of H. pylori diagnosis [5,6,7]. It is a simple and safe test, which is repeated and provides excellent accuracy for the initial diagnosis of H. pylori infection, as well as the confirmation of its eradication after treatment [7, 8]. The expired air is collected in order to measure the activity of labeled carbon so as to detect individuals with H. pylori infection [5, 9, 10]
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