Development of a novel sandwich immunoassay based on targeting recombinant Francisella outer membrane protein A for the diagnosis of tularemia

Front Cell Infect Microbiol. 2024 Aug 20:14:1455259. doi: 10.3389/fcimb.2024.1455259. eCollection 2024.

Abstract

Introduction: Tularemia, caused by the bacterium Francisella tularensis, poses health risks to humans and can spread through a variety of routes. It has also been classified as a Tier 1 Select agent by the CDC, highlighting its potential as a bioterrorism agent. Moreover, it is difficult to diagnose in a timely fashion, owing to the non-specific nature of tularemia infections. Rapid, sensitive, and accurate detection methods are required to reduce mortality rates. We aimed to develop antibodies directed against the outer membrane protein A of F. tularensis (FopA) for rapid and accurate diagnosis of tularemia.

Methods: We used a baculovirus insect cell expression vector system to produce the FopA antigen and generate anti-FopA antibodies through immunization of BALB/c mice. We then employed hybridoma and phage display technologies to screen for antibodies that could recognize unique epitopes on FopA.

Result: Two monoclonal antibodies, 6B12 and 3C1, identified through phage display screening specifically bound to recombinant FopA in a dose-dependent manner. The binding affinity of the anti-FopA 6B12 and 3C1 antibodies was observed to have an equilibrium dissociation constant of 1.76 × 10-10 M and 1.32 × 10-9 M, respectively. These antibodies were used to develop a sandwich ELISA system for the diagnosis of tularemia. This assay was found to be highly specific and sensitive, with detection limits ranging from 0.062 ng/mL in PBS to 0.064 ng/mL in skim milk matrices.

Discussion: Our findings demonstrate the feasibility of a novel diagnostic approach for detecting F. tularensis based on targeting FopA, as opposed to existing tests that target the bacterial lipopolysaccharide.

Keywords: FopA; Francisella tularensis; sandwich immunoassay; tier 1 select agent; tularemia.

MeSH terms

  • Animals
  • Antibodies, Bacterial*
  • Antibodies, Monoclonal* / immunology
  • Antigens, Bacterial / genetics
  • Antigens, Bacterial / immunology
  • Bacterial Outer Membrane Proteins* / genetics
  • Bacterial Outer Membrane Proteins* / immunology
  • Baculoviridae / genetics
  • Cell Surface Display Techniques
  • Enzyme-Linked Immunosorbent Assay / methods
  • Epitopes / immunology
  • Female
  • Francisella tularensis* / genetics
  • Francisella tularensis* / immunology
  • Humans
  • Hybridomas
  • Immunoassay / methods
  • Mice
  • Mice, Inbred BALB C*
  • Recombinant Proteins* / genetics
  • Recombinant Proteins* / immunology
  • Sensitivity and Specificity
  • Tularemia* / diagnosis

Substances

  • Bacterial Outer Membrane Proteins
  • Recombinant Proteins
  • Antibodies, Monoclonal
  • Antibodies, Bacterial
  • Epitopes
  • Antigens, Bacterial

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This research was supported by the Defense Acquisition Program Administration (ADD-911255202).