W81XWH21P0021

Small Business Innovation Research Program (SBIR) Phase I

Multiplexed, high-throughput functional assay to evaluate bactericidal activity of antibodies against Shigella

A Multiplexed, Functional Assay to Determine the Bactericidal Activity of Antibodies Against Multiple Enteric Bacterial Pathogens

Shigella infection is one of most common medical problems for deployed military personnel. Shigella infection causes acute diarrheal as well as chronic functional bowel disorders and reactive arthritis, and the infection keeps our service members out of fight, threatening unit readiness. Therefore, the need of prevention of Shigella infection has become a high priority for US Service Members. A safe and effective Shigella vaccine is therefore of paramount importance. Monitoring of Shigella vaccine effectiveness could be expedited and simplified by the ability to evaluate antibody activities. The bactericidal activity of Shigella antibodies has been used as a measure to evaluate the functional activity of antibodies. However, conventional bactericidal activity assay is based on counting the surviving bacterial forming units on plates through overnight culture, which is labor-sensitive, time-consuming, and not suitable for large-scale studies. To test the antibody against multiple serotypes, the assay must be performed on each serotype and large qualities of samples are needed. A multiplexed, high-throughput antibody bactericidal assay against an array of Shigella strains would enable large-scale sample analysis and support rapid vaccine development. Lynntech proposes to develop a rapid, high-throughput, and cost-effective multiplex assay capable of simultaneously evaluating bactericidal activity of antibodies against multiple Shigella serotypes. This assay is being designed to be simple and has the capability to provide sample-to-answer results in four hours. Furthermore, Lynntech's bactericidal assay can serve as a multiplex detection and qualification platform to evaluate bactericidal activity of antibodies without the need for culture.

The goal of phase I is to establish the technical merit, feasibility, and commercial potential of proposed R&D efforts and determine the quality of performance of the small business awardee organization.

DHA202-002

H202-002-0014

20.2

Dakota Burleson