Comparative Evaluation of the SMARTCHECK® Listeria monocytogenes Detection Kit for GENECHECKER® UF-300 Real-Time PCR System for Select Foods: AOAC Performance Tested MethodSM 042101.

Abstract

The candidate method, SMARTCHEK® Listeria monocytogenes Detection Kit, is designed for rapid detection of L. monocytogenes in select food matrixes, for use in conjunction with the Genesystems Rapi:chipTM and GENECHECKER®UF-300 real-time PCR system. The independent laboratory evaluation consisted of an inclusivity and exclusivity study, product consistency study, robustness study, stability study, and a matrix study. The paired matrix study tested stainless-steel environmental sponges, uncured ready-to-eat deli turkey, ready-to-eat deli ham, cooked shrimp, and fresh bagged spinach. The robustness study evaluated the method by changing three parameters. The accelerated stability and product consistency study was conducted at 8, 16, 24, 32, and 40 days. The candidate method was compared to the US Department of Agriculture Food Safety and Inspection Service Microbiology Laboratory Guidebook, 8.11 Isolation and Identification of Listeria monocytogenes from Red Meat, Poultry, Ready-to-Eat Siluriformes (Fish) and Egg Products, and Environmental Samples and to the US Food and Drug Administration Bacteriological Analytical Manual Chapter 10: Detection of Listeria monocytogenes in foods and Environmental Samples, and Enumeration of Listeria monocytogenes in Foods following a paired study design. All 50 L. monocytogenes isolates were detected in all three broths tested for inclusivity, while all 37 non-L. monocytogenes isolates were correctly excluded. In the matrix study, the candidate method showed no significant differences between confirmed candidate method results and reference method results for all food matrixes evaluated. The candidate method is an effective method for the qualitative detection of L. monocytogenes in select food matrixes. The SMARTCHECK Listeria monocytogenes Detection Kit assay allows for fast, reliable detection of L. monocytogenes with results obtained in approximately 35 min after 18-48 h pre-enrichment, depending on the matrix.