Validation of Romer Labs RapidChek® Listeria monocytogenes NextDay™ Plus Test System for the Detection of Listeria monocytogenes on Select Food Matrices and Environmental Surfaces: AOAC Performance Tested MethodSM 042501.

BACKGROUND: The RapidChek® Listeria monocytogenes NextDay™ Plus Test System was designed to detect Listeria monocytogenes on stainless steel and plastic environmental surfaces and in selected foods. It uses a proprietary enrichment followed by a lateral flow immunoassay to qualitatively detect L. monocytogenes. OBJECTIVE: The aim of this study was to validate the Romer Labs RapidChek® Listeria monocytogenes NextDay™ Plus Test System against the USDA-FSIS-MLG and FDA-BAM cultural reference methods for the detection of L. monocytogenes in select foods including hot dogs, frozen breaded chicken, cured ham, ice cream and cooked shrimp, and on environmental surfaces including stainless steel and plastic (polyurethane, food grade) in an unpaired study design. METHODS: The RapidChek® method uses a proprietary enrichment media system, a 44 to 48 h enrichment at 30 ± 1 °C and detects L. monocytogenes on an immunochromatographic lateral flow device within 10 minutes. Different L. monocytogenes strains were used to spike each of the matrices. Samples were confirmed based on the reference method confirmations and an alternate confirmation method. RESULTS: There were 82 RapidChek® presumptive positives matrices of which 81 were confirmed by the alternate confirmation method. The respective cultural reference methods produced 74 confirmed positives. All non-spiked samples were negative for Listeria monocytogenes by both methods. Probability of Detection (POD) analysis was performed and found no statistically significant differences between methods. CONCLUSION: The RapidChek® Listeria monocytogenes NextDay™ Plus Test System demonstrated performance comparable to the respective cultural reference methods while providing rapid results, supporting its use for monitoring L. monocytogenes in food and food processing environments. HIGHLIGHT: The method provides the end user with a rapid and reliable tool for monitoring and control of L. monocytogenes in RTE foods and environmental surfaces in accordance with their ongoing food safety needs.