Hygiena foodproof Salmonella plus Cronobacter Detection LyoKit

Hygiena has received ISO 16140-2 validation for its Multiplex RT-PCR assay for simultaneous detection of Salmonella and Cronobacter.

The Hygiena foodproof Salmonella plus Cronobacter Detection LyoKit can be used to detect both Salmonella spp. and Cronobacter spp. in a single assay in order to ensure 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 is designed to eliminate this inefficiency by detecting 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.

Hygiena is offering a multiplex PCR method 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.

Delivering results in just 19 hours, the kit is easy to use and features a streamlined workflow designed to enhance stability with lyophilised reagents, reduce contamination risks and integrate seamlessly with existing laboratory systems such as the BAX System Q7. The simplified process requires minimal training, making it accessible to a broad range of laboratory personnel.