Discipline D Special Project - Track 3: Method Development and Validation

PAR-20-105：学科D -特殊项目-专题3：方法验证

PAR-20-105: Discipline D – Special Projects - Track 3: Method Validation Project Summary The Washington State Department of Agriculture (WSDA) Food Safety and Consumer Services (FS&CS) Laboratory is the State’s Primary Regulatory Human Food and Animal Feed Safety Laboratory. We seek 5 years of funding through the FDA Laboratory Flexible Funding Model (LFFM) Cooperative Agreement Program’s Discipline D Special Projects Track 3, Method Development and Validation. We plan to utilize the funding to conduct preliminary, short-term or exploratory investigations that focus on the feasibility of a new method and/or technology. We propose to be part of the multi-laboratory validation of a qPCR screening method for Salmonella in foods in Year-1.  The FS&CS Laboratory has two decades of recent work developing new methods and validating the methods. From 2001-2013 the laboratory was one of 8 selected state agriculture laboratories for support under the USDA Microbiological Data Program. The purpose of this program was to develop and validate testing methods for fresh produce. Another purpose was to understand the frequency of detected pathogens in various produce items.  The Laboratory has extensive experience working with complicated matrices that present challenges to modern technical testing platforms. For instance, sprouts are difficult to test since there is a lot of interference with real-time PCR.  Each method for Salmonella, Listeria, E.coli O157:H7, non-O157 E.coli (STEC), Shigella had to be adapted to testing produce. This required years of work to discover, verify and validate the methods. Each matrix then had to be re-verified and validated.  The Laboratory has worked under the FDA FERN MCAP for over 10 years. A primary goal of this cooperative agreement is to develop testing methods on newer test platforms and then validate those methods. In addition, we have a long history of collaborating with private companies who manufacture test kits and analytical equipment, in order to get some of these technologies approved by AOAC and available for our commercial use.  The Laboratory utilizes the FDA Guideline for the Validation of Analytical Methods. If our Track 3 proposal is accepted, we are willing and able to do the following: 1. Participate the multi-laboratory validation of a qPCR screening method for Salmonella in foods by following FDA guidelines for method validation. Washington State Department of Agriculture, Food Safety and Consumer Services Laboratory