Validation of N-LightTM  L. monocytogenes for Detection of Listeria monocytogenes on Environmental Surfaces: AOAC Performance Tested MethodSM 122002

Abstract Background The NEMIS Technologies N-LightTM L. monocytogenes assay uses chemiluminescence designed for the qualitative detection of Listeria monocytogenes from environmental surface samples. Objective To validate the NEMIS Technologies N-Light L. monocytogenes assay as part of the AOAC Performance Tested MethodSM program for the detection of L. monocytogenes on stainless steel, plastic (polystyrene), and ceramic environmental surfaces. Method Using the Vitl Life Science Solutions Lu-mini luminometer, the NEMIS Technologies N-Light L. monocytogenes assay was compared to the ISO 11290–1:2017: Microbiology of the Food Chain—Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp. – Part 1 using a 1" × 1" stainless steel test area in an unpaired study design. Results The NEMIS Technologies N-Light L. monocytogenes assay using the Vitl Life Science Solutions Lu-mini luminometer demonstrated no statistically significant differences between presumptive and confirmed results or between candidate and reference method results. Data for additional Performance Tested MethodSM studies met acceptance criteria requirements. Conclusions The NEMIS Technologies N-Light L. monocytogenes assay is an effective method for the qualitative detection of L. monocytogenes from stainless steel, plastic (polystyrene), and ceramic environmental surface samples. Highlights The NEMIS method is the first chemiluminescence detection system based on a novel, patented, dioxetane compound.