Performance of a Multiplex Serological Helicobacter pylori Assay on a Novel Microfluidic Assay Platform
NMI Natural and Medical Sciences Institute at the University of Tuebingen, Markwiesenstr 55, 72770 Reutlingen, Germany
MyCartis, Technologiepark 4, 9052 Zwijnaarde, Belgium
Institut für medizinische Mikrobiologie, Immunologie und Hygiene, Technische Universität München, Trogerstrasse 30, 81675 Munich, Germany
UMR 5086 Molecular Microbiology and Structural Biochemistry, CNRS-Université de Lyon 1, Institut de Biologie et Chimie des Protéines, 7 Passage du Vercors, 69367 Lyon Cedex 07, France
Author to whom correspondence should be addressed.
Proteomes 2017, 5(4), 24; https://doi.org/10.3390/proteomes5040024
Received: 29 August 2017 / Revised: 19 September 2017 / Accepted: 29 September 2017 / Published: 3 October 2017
(This article belongs to the Special Issue Proteomic Biomarkers in Human Diseases)
Infection with Helicobacter pylori (H. pylori) occurs in 50% of the world population, and is associated with the development of ulcer and gastric cancer. Serological diagnostic tests indicate an H. pylori infection by detecting antibodies directed against H. pylori proteins. In addition to line blots, multiplex assay platforms provide smart solutions for the simultaneous analysis of antibody responses towards several H. pylori proteins. We used seven H. pylori proteins (FliD, gGT, GroEL, HpaA, CagA, VacA, and HP0231) and an H. pylori lysate for the development of a multiplex serological assay on a novel microfluidic platform. The reaction limited binding regime in the microfluidic channels allows for a short incubation time of 35 min. The developed assay showed very high sensitivity (99%) and specificity (100%). Besides sensitivity and specificity, the technical validation (intra-assay CV = 3.7 ± 1.2% and inter-assay CV = 5.5 ± 1.2%) demonstrates that our assay is also a robust tool for the analysis of the H. pylori-specific antibody response. The integration of the virulence factors CagA and VacA allow for the assessment of the risk for gastric cancer development. The short assay time and the performance of the platform shows the potential for implementation of such assays in a clinical setting.