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ARS Home » Pacific West Area » Albany, California » Western Regional Research Center » Produce Safety and Microbiology Research » Research » Research Project #442685

Research Project: Rapid Immunoassays for Pen-side Detection of SARS-CoV2 Viral Variants

Location: Produce Safety and Microbiology Research

Project Number: 2030-32000-011-007-I
Project Type: Interagency Reimbursable Agreement

Start Date: Oct 1, 2022
End Date: Sep 30, 2025

The objective of this research is the development of a pen-side lateral flow immunoassay (LFIA) for the detection of SARS-CoV-2 for use in USDA and CDC One Health animal screening and surveillance programs. Portable pen-side LFIA’s provide rapid disease surveillance capability in a simple format for real-time actionable test results that can be used to limit disease spread. This project will characterize anti-SARS-CoV-2 monoclonal antibodies (MAbs) generated against nucleocapsid (N) and spike (S) protein variants, identify material and define methodologies necessary for the construction of a pen-side LFIA suitable for the detection of SARS-CoV-2 variants in animals.

This proposal is focused on the evaluation of novel SARS-CoV-2 monoclonal antibodies (MAbs) and their development into a rapid pen-side lateral flow immunoassays (LFIAs) for virus detection. MAb cohorts have been generated against both the N- and S-protein variants of SARS-CoV-2 and new MAbs will be continually added as part of our ongoing ARS project plan objectives. Recombinant full-length, truncated, or composite protein sequences against N- and S-protein SAR-CoV variants will be used to characterize MAb binding specificity and identify candidate MAbs for further downstream assay development. To achieve optimal immunoassay detection sensitivities, a sandwich immunoassay format will be utilized and this requires identification of functional MAb pairs. Once candidate MAb pairs have been selected they will be optimized for performance in LFIA by evaluation of different materials, blocking reagents, chemical buffers, and molecular reporters. The utility of the LFIA as a pen-side test will require field evaluation that will involve collaborative partners and evaluation of animal samples. Further assay refinement will be performed during field trials to adjust assay methodologies, data acquisition and reporting to maximize the utility of a pen-side SARS-CoV-2 test.