Project

VRE-LFA: Rapid detection of Vancomycin-resistant Enterococcus faecium by lateral flow assay

Short description

Enterococcus faecium is intrinsically resistant to many antibiotics and can cause difficult-to-treat infections, especially in immunocompromised and other vulnerable patients. Vancomycin-resistant E. faecium (VRE) strains are especially problematic because vancomycin cannot be used to treat these infections. Resistance is mediated by the VanA or VanB enzyme complexes, which neutralize the activity of vancomycin. A rapid test capable of reliably detecting these enzyme complexes could improve diagnostics, accelerate treatment decisions, and prevent the further spread of VRE.

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In this project, an antibody-based rapid diagnostic test for vancomycin-resistant enterococci (VRE) will be developed in collaboration with the Belgian industry partner ↗ Coris BioConcept in the format of a lateral flow assay (LFA). The VRE-LFA is designed to reliably detect the expression of the VanA and VanB resistance determinants in E. faecium within 15 minutes, thereby substantially reducing the current diagnostic turnaround time of up to 20 hours. 

In addition to generating and testing monoclonal antibodies, the development of the VRE rapid test also requires the formulation of a suitable lysis buffer to enable the release of the target proteins from E. faecium in different patient samples. The prototype VRE rapid test will then be evaluated using a range of clinical VRE isolates and an in vitro intestinal model to demonstrate that the VRE LFA can rapidly and reliably detect VanA- and VanB-mediated resistance. The goal is to work with the industry partner to bring the test to market and into clinical use.

The figure illustrates the approach pursued in the VRE-LFA project toward rapid detection of vancomycin-resistant Enterococcus faecium (VRE) using a lateral flow assay (LFA). The test is designed to detect the VanA and VanB enzyme complexes within approximately 15 minutes, thereby significantly reducing the current diagnostic time of up to 20 hours. The goal is to reliably and quickly identify VRE so that effective treatments and appropriate hygiene measures can be initiated without delay.

© DZIF

In an implementation study conducted at the ↗ Institute of Medical Microbiology, Immunology and Hygiene (IMMIH) at University Hospital Cologne, the integration of the test into the routine workflow of a diagnostic laboratory will be evaluated. In the long term, the VRE-LFA is expected to enable faster and more cost-effective diagnostics while supporting timely infection control measures and appropriate treatment decisions.

The IMMIH and DZIF build on extensive experience in translational diagnostic development. Together with Coris BioConcept, they have already successfully brought two rapid tests for the detection of carbapenemase-producing Acinetobacter baumannii to market: OXA-23 K-SeT (2018) and RESIST-ACINETO (2022).

Learn more in the profile of the DZIF working group ACTIVATE: Development of Antibacterial Vaccines and Diagnostics.