Z Gastroenterol 2016; 54 - KV417
DOI: 10.1055/s-0036-1587192

Development and validation of a novel line immunoassay for diagnosis of Helicobacter pylori infection

C Nölting 1, C Reichhuber 1, L Formichella 2, H Meyer 2, O Boecher 1, E Soutschek 1, M Gerhard 3
  • 1Mikrogen GmbH, Neuried, Deutschland
  • 2Intstitut für Med. Mikrobiologie, Immunologie und Hygiene, TUM, München, Deutschland
  • 3Technische Universität München, Institut für Medizinische Mikrobiologie, Immunologie und Hygiene, München, Deutschland

Background: The infection with Helicobacter pylori (H. pylori) addects 50% percent of the world population. By colonizing the human stomach, the bacteria cause gastritis in all infected individuals. 10 – 15% of H. pylori positive individuals develop ulcer disease and 1 – 2% gastric cancer. Both, strain-specific virulence and host factors influence the course of disease. While timely eradication of the pathogen is the most effective way to prevent development of gastric cancer, it is uncertain which infected individuals are at risk and require treatment.

Material/methods: The novel recomLine Helicobacter IgG, IgA 2.0 is a qualitative line immunoassay for the detection of IgG and IgA antibodies against H. pylori in human serum or plasma. The test principle allows the simultaneous identification of multiple antibodies against 10 highly immunogenic recombinant H. pylori antigens, which are immobilized in separate lines on a test stripe.

The test performance was evaluated with 236 clinically defined specimens from patients undergoing routine endoscopy. The diagnostic sensitivity of recomLine Helicobacter 2.0 was determined with 139 samples from H. pylori infected individuals defined by histological analysis of gastric biopsies. Pathological findings such as ulcer, premalignant changes and carcinoma were recorded. The diagnostic specificity was established with 97 specimens from histologically- defined H. pylori negative individuals. In addition, the relationship between antigen reactivity profile and disease stage was evaluated as potential predictive risk marker for gastric disease in infected individuals.

Results: Using the histology findings as gold standard, the diagnostic sensitivity of recomLine Helicobacter 2.0 IgG-test to detect H. pylori infection is 99,3%. Additionally, 63,3% of H. pylori infected individuals showed a specific IgA-immune response. The diagnostic specificity evaluated with specimens of H. pylori negative patients is 100%.

Conclusions: The recomLine Helicobacter 2.0 represents a highly sensitive and specific non-invasive diagnostic tool for the serological detection of H. pylori infection. The high accuracy was confirmed by histological findings.