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

> **NIH FDA U19** · WA STATE DEPARTMENT OF AGRICULTURE · 2020 · $35,000

## Abstract

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

## Key facts

- **NIH application ID:** 10173388
- **Project number:** 1U19FD007086-01
- **Recipient organization:** WA STATE DEPARTMENT OF AGRICULTURE
- **Principal Investigator:** Yong Liu
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $35,000
- **Award type:** 1
- **Project period:** 2020-09-01 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10173388

## Citation

> US National Institutes of Health, RePORTER application 10173388, Discipline D Special Project - Track 3: Method Development and Validation (1U19FD007086-01). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10173388. Licensed CC0.

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