The U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA’s FSIS) has published a guidance that provides a list of test kits that have been validated for detection of relevant foodborne pathogens; specifically, Salmonella, Campylobacter, Listeria including Listeria monocytogenes, Shiga toxin-producing Escherichia coli O157:H7 (STEC), and non-O157 STEC.
The guidance applies to official establishments and actions they may take when considering optional, validated test kits for use to meet regulatory requirements for pathogen testing. It relates to 9 CFR Part 310.
FSIS does not specifically endorse any of the testing products listed in the guidance, and acknowledges that equivalent test kits or products may be available for laboratory use. Additionally, FSIS does not require the use of any specific test kit, including those incorporated into FSIS’s Microbiology Laboratory Guidebook (MLG) methods. Instead, establishments and laboratories should choose test kits that are:
- Validated for testing relevant foods by a recognized independent body (i.e., AOAC, AFNOR, MicroVal, or NordVal), by a U.S. regulatory body (i.e., FSIS MLG or the U.S. Food and Drug Administration’s Bacteriological Analytical Manual), or the International Organization for Standardization (ISO) process
- Fit for the intended purpose and application (e.g., validated for the appropriate matrix and sample size to detect the appropriate foodborne pathogen)
- Performed per the conditions of the validated protocol by a laboratory that assures the quality of the analytical results.
FSIS intends to update validated test kit lists on a quarterly basis.
