Performance evaluation of a rapid whole-blood immunoassay for the detection of IgG antibodies against Helicobacter pylori in daily clinical practice. Issue 1 (December 2016)

• Record Type: Journal Article
• Authors: Enko, Dietmar; Halwachs-Baumann, Gabriele; Stolba, Robert; Rössler, Ortrun; Kriegshäuser, Gernot
• Is Part Of: Annals of clinical microbiology and antimicrobials. Volume 15:Issue 1(2016)
• Page Start: 1
• Page End: 5
• Publication Date: 2016-12
• Subjects: Helicobacter pylori -- Immunoassay -- Laboratory diagnosis; Medical microbiology -- Periodicals; Anti-infective agents -- Periodicals; 616.9041
• DOI: 10.1186/s12941-016-0161-1
• Languages: English
• ISSNs: 1476-0711

Abstract

Abstract Background A growing number of rapidHelicobacter 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 againstH. pylori with the13 C-urea breath test (13 C-UBT) serving as a reference method. Methods A total of 108 consecutive outpatients, who were referred for13 C-UBT by general practitioners and specialists, were also tested forH. 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 the13 C-UBT. The agreement between the two tests was calculated using Cohen's Kappa (κ) with 95 % confidence intervals (CI). Results The agreement between the gabControl® H. pylori assay and the13 C-UBT was 0.62 [95 % confidence intervals (CIs) 0.47–0.76; P < 0.001]. With the13 C-UBT serving as the non-invasive gold standard method ofH. 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 positiveH. pylori anamnesis showed a negative13 C-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 The gabControl® H. pylori immunoassay is a rapid and easy to use first line screening tool forH. pylori IgG antibody detection in daily clinical practice. However, this assay should not be used for confirmation of the successfulH. pylori eradication after antibiotic treatment.