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Journal of Immunology Research
Volume 2017, Article ID 8394593, 10 pages
Research Article

Validation of a Novel Immunoline Assay for Patient Stratification according to Virulence of the Infecting Helicobacter pylori Strain and Eradication Status

1Institute for Medical Microbiology, Immunology and Hygiene, Technische Universität München, Munich, Germany
2Department of Pathology, Klinikum Bayreuth, Bayreuth, Germany
3Private Practice for Gastroenterology, Alexanderstr. 2, 95444 Bayreuth, Germany
4Mikrogen GmbH, Neuried, Germany
5Department of Gastroenterology, Hepatology and Gastrointestinal Oncology, Bogenhausen Academic Teaching Hospital, Munich, Germany
6Institute for Medical Statistics and Epidemiology, Technische Universität München, Munich, Germany
7Erasmus MC University Medical Center, Gastroenterology and Hepatology Rotterdam, Rotterdam, Netherlands
8Private Practice for Gastroenterology, Einsteinstraße 1, 81675 Munich, Germany
9DZIF German Centre for Infection Research, Munich, Germany

Correspondence should be addressed to Markus Gerhard; ed.mut@drahreg.sukram

Received 6 November 2016; Revised 12 February 2017; Accepted 15 March 2017; Published 30 May 2017

Academic Editor: Kristen M. Kahle

Copyright © 2017 Luca Formichella et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Helicobacter pylori infection shows a worldwide prevalence of around 50%. However, only a minority of infected individuals develop clinical symptoms or diseases. The presence of H. pylori virulence factors, such as CagA and VacA, has been associated with disease development, but assessment of virulence factor presence requires gastric biopsies. Here, we evaluate the H. pylori recomLine test for risk stratification of infected patients by comparing the test score and immune recognition of type I or type II strains defined by the virulence factors CagA, VacA, GroEL, UreA, HcpC, and gGT with patient’s disease status according to histology. Moreover, the immune responses of eradicated individuals from two different populations were analysed. Their immune response frequencies and intensities against all antigens except CagA declined below the detection limit. CagA was particularly long lasting in both independent populations. An isolated CagA band often represents past eradication with a likelihood of 88.7%. In addition, a high recomLine score was significantly associated with high-grade gastritis, atrophy, intestinal metaplasia, and gastric cancer. Thus, the recomLine is a sensitive and specific noninvasive test for detecting serum responses against H. pylori in actively infected and eradicated individuals. Moreover, it allows stratifying patients according to their disease state.