Comparative Evaluation of the SMARTCHEK Salmonella Species Detection Kit for GENECHECKER UF-300 Real-Time PCR System with Rapi:chipTM and Rapi:DirectTM Lysis Buffer for Select Foods: AOAC Performance Tested MethodSM 032101

Abstract

The candidate method, SMARTCHEK Salmonella spp. Detection Kit assay is designed for rapid detection of Salmonella spp. 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 romaine lettuce, peanut butter, liquid whole egg, chicken carcass rinsate, and raw chicken. The robustness study evaluated the method by changing three method 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 U.S. Department of Agriculture Food Safety and Inspection Service Microbiology Laboratory Guidebook 4.10 Isolation and Identification of Salmonella from Meat, Poultry, Pasteurized Egg, and Siluriformes (Fish) Products and Carcass and Environmental Sponges and to the U.S. Food and Drug Administration Bacteriological Analytical Manual, Chapter 5: Salmonella following a paired study design. All 108 Salmonella isolates were detected in all three broths tested for inclusivity, while all 35 non-Salmonella 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 Salmonella spp. in select food matrixes. The SMARTCHEK Salmonella spp. Detection Kit assay allows for fast, reliable detection of Salmonella spp. with results obtained after 24 h of incubation and a PCR run time of only 35 min.