Hygiena has set a new industry standard with the launch of its groundbreaking foodproof Salmonella plus Cronobacter Detection LyoKit.
This innovative workflow solution is the first and only ISO 16140-2 approved rapid, real-time PCR test that enables manufacturers to detect Salmonella spp. and Cronobacter spp. in a single assay, delivering unparalleled efficiency and regulatory compliance.
Ensuring the safety of infant formulas and related ingredients has been a top priority for manufacturers worldwide. Regulatory agencies such as the FDA, EFSA, FSANZ, and SAMR mandate stringent testing protocols 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 foodproof Salmonella plus Cronobacter Detection LyoKit has eliminated 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.
"At Hygiena, we are committed to delivering solutions that not only meet but exceed industry standards in food safety," said Steve Nason, CEO of Hygiena.
"By introducing the foodproof Salmonella plus Cronobacter Detection LyoKit, we are providing manufacturers with a faster, more cost-effective and highly reliable testing method that ensures compliance and safeguards consumers. This is a significant step forward in our mission to create innovative diagnostics for a healthier world."
The foodproof Salmonella plus Cronobacter Detection LyoKit is validated according to the ISO 16140-2 standard by AFNOR Certification. This validation ensured 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 the first-ever multiplex PCR method specifically designed to address the unique pathogenic challenges of the powdered infant formula industry.
In response to evolving industry practices, this groundbreaking method has been validated for test portion sizes up to 375 grams, ensuring it meets the stringent needs of end-users while delivering robust and reliable results.
The ISO 16140-2 performance metrics provide food safety teams with reliable, specific, sensitive, reproducible and regulatory-compliant pathogen detection results.
Unlike alternative methods, which require 18 to 20 hours of incubation for a single pathogen target, Hygiena’s test reduced the enrichment time to 16 hours while simultaneously detecting both Salmonella and Cronobacter. This accelerated process has enabled manufacturers to reduce holding times, cut costs, and minimise the risk of product recalls.
Designed for ease of use, the foodproof Salmonella plus Cronobacter Detection LyoKit features a streamlined workflow that has enhanced stability with lyophilised reagents, reduced contamination risks and integrated 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.
The foodproof Salmonella plus Cronobacter Detection LyoKit joined Hygiena's comprehensive suite of ISO 16140-2 validated assays, including those for Listeria spp. and L. monocytogenes, ensuring robust and reliable pathogen detection across various food matrices.
