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Validation Renewal for Salmonella Detection Method Can Reduce Test Verification Requirements for Food Testing Laboratories


News provided by

Thermo Fisher Scientific

11 Jun, 2018, 12:00 GMT

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NF VALIDATION certification for Salmonella species PCR Assay renewed according to the latest NF EN ISO Reference Methods

BASINGSTOKE, England, June 11, 2018 /PRNewswire/ -- Laboratories performing tests for the detection of Salmonella species in foods and associated samples can now do so without the need for additional internal validation work to show equivalence to the new Salmonella ISO standard.

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Thermo Fisher Scientific has recently extended the NF VALIDATION mark by AFNOR Certification for the Thermo Scientific SureTect Salmonella species PCR Workflow which features simple sample preparation and next day results from meat, dairy, seafood, vegetables and powdered infant formula samples (with and without probiotics), as well as pet food and production environment samples. The SureTect Salmonella species Assay was originally validated according to EN ISO16140:2003 in the context of NF VALIDATION by AFNOR Certification on two different PCR platforms: the Thermo Scientific SureTect PikoReal PCR Instrument for human foods and pet foods and the Applied Biosystems 7500 Fast PCR Instrument for human foods and production environment samples. The reference method EN ISO 6579:2002 was used during the initial validation studies.

In accordance with ISO16140:2003, in order to obtain the broad range of foods claim a minimum of four food categories were required to be validated. With the publication of the new EN ISO16140:2016 standard, the minimum requirement has changed to five food categories and the minimum number of inclusivity isolates required during the validation study has increased from fifty to one hundred.

Following the positive agreement expressed by the Technical Board of the NF VALIDATION mark, the NF VALIDATION certification for the SureTect Salmonella species Assay has been renewed by comparison to the reference method EN ISO 6579:2017 and following ISO 16140-2:2016.

"By achieving the NF VALIDATION certification for the SureTect Salmonella species PCR Workflow in line with the latest ISO methods, we have further demonstrated it to be a reliable and robust method," comments Bernd Hofmann, vice president of marketing, microbiology, Thermo Fisher Scientific. "Maintaining the broad range of foods claim will help our customers minimise in-house verification that could be required because of the updates to the ISO methods."

The SureTect Salmonella species PCR Workflow offers:

  • Simple sample enrichment and PCR preparation protocols – fast & scalable for small to higher-throughput laboratories
  • Excellent sensitivity, specificity and reliability as evidenced through the NF VALIDATION studies
  • Confidence in results – AFNOR Certification following the latest ISO reference methods

In addition to the SureTect Salmonella species Solution, Thermo Fisher Scientific provides real-time PCR-based workflow solutions and other methods to test for a broad range of food safety and quality indicators, as well as an expanding range of custom developed assays. All of our PCR solutions are designed to run on the Applied Biosystems 7500 Fast Real-Time PCR System which provides expansive molecular capability and streamlined testing processes which may reduce overall costs. Find out more by visiting www.thermofisher.com/foodmicrosolutions

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of more than $20 billion and approximately 70,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services. For more information, please visit www.thermofisher.com.

Contact Information:
Carlene Graham, Thermo Fisher Scientific
Phone: +1 800-871-8909 x3224109
E-mail: carlene.graham@thermofisher.com

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