Validation of N-Light™ Salmonella Risk Test Kit for Detection of Salmonella spp. on Environmental Surfaces: AOAC Performance Tested Method(SM) 072204

BACKGROUND: The NEMIS N-Light™ Salmonella Risk method uses 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 to the AOAC Performance Tested Methods(SM) (PTM) program for the detection of Salmonella spp. on stainless-steel, polystyrene, and ceramic environmental surfaces. METHOD: 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 on stainless-steel, polystyrene, and ceramic environmental surfaces. HIGHLIGHTS: The NEMIS Technologies N-Light Salmonella Risk assay, which is the first chemiluminescence-based detection system that uses a novel, patented dioxetane compound, allowing for easy and rapid detection of Salmonella.