ACCELERATING FOOD SAFETY: NEXT-GENERATION FOODBORNE PATHOGEN RAPID TEST KITS WITH ENZYME AMPLIFICATION

Our goal is to fulfill all certification requirements by the Association of Official Analytical Collaboration (AOAC) International for our lead foodborne pathogen rapid test kits (RTKs): E. coli (EC) O157:H7 and Salmonella Enteritidis (SE), and develop large-scale manufacturing methods to scale up RTK production, to aid our product launch and marketing during commercialization.Our key objectives are:Develop large-scale manufacturing methods.Production protocol with semi-automated equipment.Sourcing and selection of suitable production materials.Optimize composition/concentration of production reagents.Set up quality control (QC) and quality assurance (QA) plan and requirements.Documentation that complies with a suitable quality management system.Meet AOAC certification requirements for SE and EC O157:H7 RTKs.Inclusivity and exclusivity studies for target and non-target bacteria species.RTK characterization and robustness tests.Method comparison with gold standards, i.e. FDA's Bacteriological Analytical Manual (BAM), Food Safety and Inspection Service's (FSIS) Microbiology Laboratory Guidebook (MLG).Validation of RTK with relevant food matrices via both in-house and independent laboratory testing.Long-term stability and reproducibility/repeatability tests.Commence verification of RTK in field settings by commercial partners potentially upon AOAC certification.Understand partners' workflow.Implementing RTKs at the appropriate stages of their workflow to achieve time and cost savings.