BAX® System assays now meet new ISO 16140-2 standard for all AFNOR-approved methods

Posted: 2 July 2018 | | No comments yet

Key European standards organization grants extension to now cover 10 BAX® System PCR assays for Salmonella, E. coli O157:H7, L. monocytogenes and Genus Listeria

CAMARILLO, Calif. (26 June 2018)—AFNOR, an ISO certification body in France that is a widely recognized European accreditation body of food safety detection methods, has now issued extensions in accordance with the new ISO standard 16140-2 for all 10 BAX® System assays previously certified.

In addition to extending all the assays to the newest ISO standard and software version, the BAX® System Real-Time PCR assay for Salmonella was also extended for dairy (except powdered milk) and chocolate food categories and a shortened enrichment protocol for raw meats and raw seafood. With these additions, the BAX® System Real-Time PCR assay for Salmonella is now certified for all human food products, pet food and environmental samples (except primary production samples). The 10 assays (real-time and traditional PCR) are listed below:

BAX System Real-Time and traditional assays meeting ISO 16140-2 and AFNOR standards:

  • BAX® System Real-Time PCR assay for Salmonella
  • BAX® System Real-Time PCR assay for E. coli O157:H7
  • BAX® System PCR assay for Salmonella/ Salmonella 2
  • BAX® System X5 PCR Assay for Salmonella
  • BAX® System PCR assay for Listeria monocytogenes 24E
  • BAX® System X5 PCR Assay for Listeria monocytogenes
  • BAX® System PCR Assay for E. coli O157:H7 MP
  • BAX® System X5 PCR Assay for E. coli O157:H7
  • BAX® System PCR Assay for Genus Listeria 24E
  • BAX® System X5 PCR Assay for Genus Listeria

“These certifications from AFNOR, which is recognized internationally, emphasizes the ability of our PCR assays to detect potentially pathogenic bacteria in food and environmental samples with performance equal to or better than the ISO reference method,” said Ed Luterbach, Chief Commercialization Officer at Hygiena. “We believe we are the only company that has all of its PCR assays AFNOR-validated. These certifications are backed up by independent studies that have demonstrated the effectiveness of the BAX® System in a variety of facilities and situations.”

ABOUT ISO 16140-2
The International Organization for Standardization (ISO) standard 16140-2 specifies a technical protocol to validate alternative methods of microbiology to reference methods for testing in the food chain. It is used to validate methods for the analysis of microorganisms (bacteria and fungi in particular) in food, animal feed, environmental samples, and primary production sample.

The Association Française de Normalisation (AFNOR), established in 1926, is France’s official organization for coordinating standards development for a wide range of industrial processes, including food safety verification. It is a member association of the ISO. AFNOR Certification is internationally recognized and operates through over 40 offices worldwide. It has a global network of auditors, cooperating with technical partners, large laboratories, technical centers and inspection bodies.

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