Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
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SHR Neuro Krebs Kardio Lipid Stoffw Microb
Enko, D; Halwachs-Baumann, G; Stolba, R; Rössler, O; Kriegshäuser, G.
Performance evaluation of a rapid whole-blood immunoassay for the detection of IgG antibodies against Helicobacter pylori in daily clinical practice.
Ann Clin Microbiol Antimicrob. 2016; 15(1):47-47
Doi: 10.1186/s12941-016-0161-1
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- Führende Autor*innen der Med Uni Graz
- Enko Dietmar
- Co-Autor*innen der Med Uni Graz
- Baumann Gabriele
- Kriegshäuser Gernot
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- Abstract:
- A 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 (13)C-urea breath test ((13)C-UBT) serving as a reference method. A total of 108 consecutive outpatients, who were referred for (13)C-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 (13)C-UBT. The agreement between the two tests was calculated using Cohen's Kappa (κ) with 95 % confidence intervals (CI). The agreement between the gabControl(®) H. pylori assay and the (13)C-UBT was 0.62 [95 % confidence intervals (CIs) 0.47-0.76; P < 0.001]. With the (13)C-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 (13)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. The 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.
- Find related publications in this database (using NLM MeSH Indexing)
- Adolescent -
- Adult -
- Aged -
- Aged, 80 and over -
- Anti-Bacterial Agents - therapeutic use
- Antibodies, Bacterial - blood
- Bacteremia - diagnosis
- Bacteremia - drug therapy
- Bacteremia - microbiology
- Breath Tests -
- Carbon Isotopes -
- Germany -
- Helicobacter Infections - diagnosis
- Helicobacter Infections - drug therapy
- Helicobacter Infections - microbiology
- Helicobacter pylori - immunology
- Helicobacter pylori - isolation & purification
- Humans -
- Immunoassay - standards
- Immunoglobulin G - blood
- Middle Aged -
- Sensitivity and Specificity -
- Urea - analysis
- Urea - metabolism
- Find related publications in this database (Keywords)
- Helicobacter pylori
- Immunoassay
- Laboratory diagnosis