LAUSR

BACKGROUND The NEMIS N-Light™ Salmonella Risk method utilizes chemiluminescence designed for the qualitative detection of Salmonella spp. from environmental surface samples. OBJECTIVE To validate the N-Light™ Salmonella Risk assay using independent and method developer validation studies according the AOAC Performance Tested MethodsSM (PTM) Program for the detection of Salmonella spp. On stainless steel, polystyrene, and ceramic environmental surfaces. METHODS The N-Light Salmonella Risk assay was evaluated in a matrix study in comparison to the ISO 6579-1:2017 method ("Microbiology of the food chain - Horizontal method for the detection, enumeration and serotyping of Salmonella - Part 1: Detection of Salmonella spp.") using an unpaired study design. Additional PTM studies performed were inclusivity/exclusivity, robustness, product consistency and stability. RESULTS The N-Light Salmonella Risk assay demonstrated a specific detection of all Salmonella strains tested. In the matrix study the N-Light Salmonella Risk assay showed no significant differences between presumptive and confirmed results, or between candidate and reference method results on the three surfaces evaluated. Data for additional PTM studies met acceptance criteria requirements. CONCLUSIONS The NEMIS Technologies N-Light Salmonella Risk assay is an effective method for the qualitative detection of Salmonella from stainless steel, polystyrene, and ceramic environmental surfaces. HIGHLIGHTS The NEMIS Technologies N-Light Salmonella Risk assay which is the first chemiluminescence based detection system applying on a novel, patented dioxetane compound allows an easy and rapid detection of Salmonella.