Hygiena receives ISO validation for Salmonella and Cronobacter detection

Hygiena has received ISO 16140-2 validation from AFNOR Certification for its Salmonella plus Cronobacter Detection LyoKit. It is the first multiplex real-time PCR assay to be approved under the standard for the simultaneous detection of Salmonella spp. and Cronobacter spp. in a single test, the company says.

The test has been developed to address food safety requirements in the infant formula sector, where contamination by Salmonella and Cronobacter represents a recognised risk. Current regulations in several regions, including the FDA (United States), EFSA (European Union), FSANZ (Australia and New Zealand), and SAMR (China), require manufacturers to undertake routine testing for these pathogens. Traditionally, laboratories have relied on separate assays for each, resulting in longer processing times and higher operational costs.

The LyoKit enables both pathogens to be tested simultaneously, reducing the time to result and simplifying laboratory workflows. The assay has been validated across a variety of matrices, including powdered infant formula (with and without probiotics), production ingredients, and environmental samples. It supports test portions of up to 375 grams, in line with industry testing practices.

The LyoKit uses lyophilised reagents, which help improve shelf-life and reduce contamination risk. It is designed to be compatible with existing equipment, such as the BAX System Q7, and requires minimal technical training.

This method joins Hygiena’s portfolio of ISO 16140-2 validated assays, which also includes tests for Listeria spp. and Listeria monocytogenes. The validation supports laboratories in meeting regulatory standards and maintaining consistent, reliable results in pathogen detection workflows.