Validation of the PhageDx™ Listeria assay for detection of Listeria spp. on stainless steel and ceramic environmental surfaces AOAC Performance Tested Method^SM 102005.

Background. The PhageDx™ Listeria Assay is a simple, specific, and sensitive assay based on the infection of Listeria spp. By selected bacteriophages and the resultant expression of a luciferase reporter gene. Results. Are generated in as little as 24.5 h for stainless steel and ceramic environmental surfaces. Objective. An AOAC Performance Tested Methods^SM (PTM) study was conducted to validate the PhageDx Listeria Assay for the detection of Listeria on stainless steel and ceramic surfaces. Method. The performance of the PhageDx method was compared to that of the U.S. Food and Drug Administration (FDA) Bacterial Analytical Manual (BAM) Ch. 10. Inclusivity/exclusivity, product consistency and stability, and robustness testing also were conducted. Results. Inclusivity testing demonstrated that the reporter bacteriophages were specific for Listeria ssp. and detected 58/61 Listeria strains tested, including all 34 L. monocytogenes strains. The reporter bacteriophage also was shown to not detect 46/47 non-Listeria bacteria in...