Hygiena first to secure ISO 16140-2 validation for multiplex RT-PCR assay detecting Salmonella, Cronobacter
Hygiena’s test reduces enrichment time to 16 hours while simultaneously detecting Salmonella and Cronobacter, enabling manufacturers to shorten holding times, cut costs, and reduce recall risks.
U.S.A. – Hygiena®, a One Health Diagnostics and food safety solutions provider, has become the first manufacturer to secure ISO 16140-2 validation for its multiplex PCR assay – foodproof® Salmonella plus Cronobacter Detection LyoKit® – enabling the simultaneous detection of Salmonella and Cronobacter species (spp.).
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 test, delivering efficiency and regulatory compliance.
The ISO 16140-2 standard validation by AFNOR Certification 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.
It specifies the general principle and the technical protocol for the validation of alternative, mostly proprietary, methods for microbiology in the food chain, particularly applicable to bacteria and fungi, with some clauses applicable to other (micro) organisms or their metabolites on a case-by-case basis.
ISO 16140-2 performance metrics provide food safety teams with reliable, specific, sensitive, reproducible and regulatory-compliant pathogen detection results.
“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,” said Steve Nason, CEO of Hygiena.
The foodproof® Salmonella plus Cronobacter Detection LyoKit®
While the multiplex PCR method is specifically designed to address the unique pathogenic challenges of the powdered infant formula industry, the Detection LyoKit further streamlines workflows and shortens the time it takes to obtain results for infant formula producers, ingredient suppliers and environmental monitoring programs.
In response to evolving industry practices, this 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.
It delivers results in 19 hours, whereas alternative methods usually 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, enabling manufacturers to reduce holding times, cut costs and minimize the risk of product recalls.
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.
About Hygiena®
Hygiena delivers rapid microbial detection, monitoring, and identification solutions to a wide range of industries, including food and beverage, healthcare, hospitality, pharmaceuticals, and personal care.
Utilizing advanced technologies and patented designs, Hygiena provides industry-leading ATP monitoring systems, PCR-based pathogen detection and characterization systems, allergen tests, environmental collection devices, and more.
The company is headquartered in Camarillo, California, with multiple offices around the world, including Wilmington, Delaware, United Kingdom, Spain, Canada, Mexico, Australia, Brazil and China, and over 180 distributors in more than 100 countries worldwide.
Its holistic ‘One Health Diagnostics’ approach ties the health of people to animals and the environment, leveraging sophisticated data management.
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