Foodborne Pathogen Test Kits Validated by Independent Organizations

FSIS is making available a list of test kits that have been validated for detection of relevant foodborne pathogens (i.e., Salmonella , Campylobacter , Listeria spp. including L. monocytogenes, E. coli O157:H7 and non-O157 STEC). The list is intended to be informational and is not an endorsement or approval of any specific test kit, regardless of its inclusion in the list. intended to be informational and are not an endorsement or approval of any particular method, regardless of its inclusion in the list. FSIS does not specifically endorse any of the mentioned test kits or products and acknowledges that equivalent test kits or products may be available for laboratory use. Likewise, FSIS does not require the use of any specific test kit, including those incorporated into FSIS’s Microbiology Laboratory Guidebook methods. Instead, establishments and laboratories should choose test kits that are: 1)Validated for testing relevant foods by a: a)Recognized independent body (i.e., AOAC, AFNOR, MicroVal, NordVal), b)U.S. regulatory body (i.e., FSIS MLG or FDA BAM), or c) International Organization for Standardization (ISO) process 2)In addition, the validated method should be: a)Fit for the intended purpose and application (e.g., validated for the appropriate matrix and sample size to detect the appropriate foodborne pathogen), and b)Performed per the conditions of the validated protocol by a laboratory that assures the quality of the analytical results. The table below contains a list of foodborne pathogen test kits that are validated by recognized independent organizations (i.e., AOAC, AFNOR, MicroVal, NordVal) and therefore meet criterion 1a above. However, the test kits in this list are not necessarily equivalent or appropriate for all testing applications. FSIS intends to update validated test kit lists on a quarterly basis.

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