Hygiena foodproof Salmonella plus Cronobacter Detection LyoKit

Hygiena’s foodproof Salmonella plus Cronobacter Detection LyoKit is an ISO 16140-2 approved, rapid, real-time PCR test that enables manufacturers to detect both Salmonella spp. and Cronobacter spp. in a single assay, thus delivering efficiency and regulatory compliance.

Regulatory agencies such as the FDA, EFSA, FSANZ and SAMR mandate stringent testing protocols for infant formulas and related ingredients to prevent contamination by Salmonella and Cronobacter — two pathogens that pose serious health risks to infants. Traditionally, food safety laboratories performed separate tests for each pathogen, which increased costs and delayed results. Hygiena’s kit detects both pathogens in a single test, streamlining workflows and accelerating time-to-results for infant formula producers, ingredient suppliers and environmental monitoring programs.

The kit is validated according to the ISO 16140-2 standard by AFNOR Certification. This validation ensures high accuracy across a range of matrices, including powdered infant formula (both with and without probiotics), related production ingredients and environmental samples from manufacturing facilities.

The multiplex PCR method is specifically designed to address the unique pathogenic challenges of the powdered infant formula industry. In response to evolving industry practices, this method has been validated for test portion sizes up to 375 g. The ISO 16140-2 performance metrics are designed to provide food safety teams with specific, sensitive, reproducible and regulatory-compliant pathogen detection results.

Speed is crucial in food safety testing and the kit delivers results in just 19 h. Unlike alternative methods that require 18–20 h of incubation for a single pathogen target, the test reduces the enrichment time to 16 h while detecting both Salmonella and Cronobacter simultaneously. 

The easy-to-use kit features a streamlined workflow that is designed to enhance stability with lyophilised reagents, reduce contamination risks and integrate seamlessly with existing laboratory systems such as the BAX System Q7. This simplified process requires minimal training, making it accessible to a broad range of laboratory personnel.