Statement of Objectives - Request for Information STEC tests kits

US Department of Agriculture (USDA)

Statement of Objectives

Project Title
Commercial Products used to Detect and Identify Shiga toxin-producing Escherichia coli (STEC) in Food

1.0 Purpose

The purpose of the Statement of Objectives (SOO) is to gather information on the commercial availability of kits for STEC detection and identification in raw beef or other food products. FSIS seeks to understand the level of granularity in STEC tests, specifically if the test provides stx subtype information.

2.0 Scope

The USDA Food Safety and Inspection Service (FSIS) Laboratory System continually incorporates new approaches to our laboratory testing and data analytics workflows to increase efficiencies in our food safety system. For example, FSIS laboratories incorporated an additional screening test into the STEC laboratory method to provide high confidence that the stx and eae genes are in the same cell, thereby increasing the likelihood that a screen positive result leads to a confirmed positive. The Agency is data driven and is considering best approaches to optimize risk-based regulatory controls for STEC.

3.0 Background

FSIS is the public health regulatory agency within the USDA responsible for inspecting establishments producing meat, poultry, and egg products and verifying that these products are safe, wholesome, and properly labeled. FSIS employs approximately 7,500 people, including inspection personnel working in 7,100 federally inspected establishments, scientists and staff in three FSIS laboratories, and investigators nationwide. The high throughput FSIS laboratories operate 365 days a year, analyzing hundreds of product samples each day to identify potential hazards and threats to the food supply. During Fiscal Year 2025, FSIS analyzed more than 109,000 meat, poultry and pasteurized eggs samples submitted by inspectors, which produced more than12,900 bacterial isolates and generated more than 2.2 million individual test results. FSIS annually tests more than 20,000 raw beef samples, including domestic and imported raw ground beef, ground beef components, bench trim, and beef manufacturing trim for the presence of the “top seven” STEC serogroups (O26, O45, O103, O111, O121, O145, O157). The current methodology can be found online in Microbiology Laboratory Guidebook (MLG) 5C.

4.0 Performance Objectives

4.1 Company Overview and Capability Summary

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Provide a brief overview of the vendor's portfolio of testing kits and or technologies that can be used to support STEC testing that detects and identifies stx/eae carrying strains