Validation of PhageDxâ„¢ Cronobacter Assay for the identification of Cronobacter Spp. in powdered infant formula: AOAC Performance Tested Method^SM 051803.

Background. The PhageDx^TMCronobacter Assay is based on the infection of Cronobacter spp. By specific bacteriophages and expression of a luciferase reporter gene. Results. Are generated in as little as 18.5 h for powdered infant formula (PIF). Objective. An AOAC Performance Tested Methods.^SM (PTM) study was conducted to validate the PhageDx Cronobacter Assay for the detection of Cronobacter in 10,100, and 300g milk-and soy-based PIF test portions. Methods. The performance of the PhageDx method was compared to the ISO 22964:2006/2017 Microbiology of the Food Chain-Horizontal Method for the Detection of Cronobacter spp. And the U.S. Food and Drug Administration (FDA) Bacteriological Analytical Manual (BAM) Chapter 29 Cronobacter: 2012. Inclusivity/exclusivity, product consistency and stability, and robustness testing also were conducted. Results. There was no significant difference between the 10,100, or 300g test portions for the milk and soy PIF matrixes between the PhageDx Cronobacter Assay, the ISO 22964:2006/2017,...