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Hygiena Announces ISO 16140-2 Validation for Multiplex RT-PCR Detection of Salmonella and Cronobacter
Image credit: Hygiena
Hygiena recently announced 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 both Salmonella spp. and Cronobacter spp. in a single assay, delivering unparalleled efficiency and regulatory compliance.
Ensuring the safety of infant formulas and related ingredients is 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 have performed separate tests for each pathogen, which increases costs and delays results. Hygiena’s foodproof Salmonella plus Cronobacter Detection LyoKit eliminates 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 foodproof Salmonella plus Cronobacter Detection LyoKit 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 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, the 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.
Speed is crucial in food safety testing, and the foodproof Salmonella plus Cronobacter Detection LyoKit delivers results in just 19 hours. Unlike alternative methods that require 18–20 hours of incubation for a single pathogen target, Hygiena’s test reduces the enrichment time to 16 hours while detecting both Salmonella and Cronobacter simultaneously. This accelerated process enables manufacturers to reduce holding times, cut costs, and minimize the risk of product recalls.
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Designed for ease of use, the foodproof Salmonella plus Cronobacter Detection LyoKit features a streamlined workflow that enhances stability with lyophilized reagents, reduces contamination risks, and integrates 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 joins 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.
