Performance of a Multiplex Serological Helicobacter pylori Assay on a Novel Microfluidic Assay Platform

Abstract

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.

A retrospective study assessing the acceleration effect of type I Helicobacter pylori infection on the progress of atrophic gastritis

“…This study showed that type I H. pylori infection could increase the level of serum PGI, PGII and G-17, possibly because the inflammatory mechanism. The study of H. pylori virulence factors were focused on the gene level, depicting that CagA and VacA gene positive samples have strong correlation with AG and IM, and can better predict AG and IM 32 , 33 . Some studies have found that the invasion ability of H. pylori infection is associated with the middle region of the vacA gene 34 , 35 .…”

Current understanding and management of Helicobacter pylori infection: an updated appraisal

“…Currently, the diagnosis of H. pylori infection is carried out by invasive (for example, endoscopy and endoscopic biopsy for histopathology, culture, and rapid urease test) and non-invasive (for example, urea breath tests, stool antigen test, and serological tests) methods 35 . However, the diagnostic preferences are based on the prevalence of H. pylori infection and age-related gastric cancer incidence in each area.…”

Prevalence of Helicobacter pylori infection in adult patients with dyspeptic symptoms in Abdi Waluyo Hospital Jakarta from January 2017 to December 2019

“…Positive UBT indicates an active H. pylori infection which require treatment or further confirmation with invasive procedures. 7 Therefore, this study aims to describe the Prevalence of Helicobacter pylori infection in adult patients with dyspeptic symptoms in Abdi Waluyo Hospital Jakarta from January 2017 to December 2019, where we tried to confirmed the positive UBT result with morphological images of the gaster by gastroscopy.…”