Evaluation Of The Gene-Up (R) Salmonella Method For The Detection Of Salmonella Species In A Broad Range Of Foods And Select Environmental Surfaces: Collaborative Study, First Action 2020.02

Background: The GENE-UP (R) Salmonella assay (Performance Tested Method(SM) [PTM] 121802) is a PCR detection method that utilizes fluorescence resonance energy transfer (FRET) hybridization probes for the rapid detection of Salmonella species in foods and on environmental surfaces.Objective: The purpose of this validation was to evaluate the method's interlaboratory performance for submission to AOAC INTERNATIONAL for adoption as First Action Official Method of Analysis(SM).Method: The GENE-UP method was evaluated in a multi-laboratory study using unpaired test portions for one food matrix, raw ground beef (80% lean). The candidate method was compared to the US Department of Agriculture (USDA), Food Safety Inspection Service, Microbiology Laboratory Guidebook (MLG) 4.10 reference method. An alternative confirmation procedure, using ASAP (TM) and CHROMID (R) Salmonella chromogenic agars, was included in the validation study. Fifteen collaborators from 14 laboratories participated. Three levels of contamination were evaluated: a non-inoculated control level (0 CFU/test portion), a low contamination level (similar to 0.7 CFU/test portion), and a high contamination level (similar to 2 CFU/test portion). Data were analyzed using the probability of detection (POD) statistical model.Results: The dLPOD(C) values with 95% confidence interval for the GENE-UP Salmonella method, with either alternative or traditional confirmation, were: 0.00 (-0.03, 0.03), -0.02 (-0.15, 0.12), and 0.02 (-0.03, 0.09) for the non-inoculated, low, and high contamination levels respectively.Conclusions: The dLPOD(C) results demonstrate no difference in performance between the candidate method and reference method for the matrix evaluated.Highlights: The GENE-UP Salmonella method, with ASAP and CHROMID Salmonella, provides industry with a simplified, rapid, and accurate workflow for the detection of Salmonella in a broad range of foods and select environmental surfaces.