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Performance evaluation of a rapid whole-blood immunoassay for the detection of IgG antibodies against Helicobacter pylori in daily clinical practice.
D. Enko, G. Halwachs-Baumann, R. Stolba, O. Rössler, G. Kriegshäuser
Ann. Clin. Microbiol. Antimicrob. 2016 Aug;15(1):47.
PubMed: 27503600
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
Associated compounds:
Compound Name
with link to compound page |
Structure | Number of references |
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Urea | 1130 |