First MicroVal certificate for MCS Diagnostics’ CertaBlue detection method

In September 2022, MicroVal has approved the issuing of the certificate for MCS Diagnostics’ CertaBlue TVC for the detection of Total Viable Count. WFC has carried out the validation study of this rapid method, based on ISO 16140-2:2016, for the scope of broad range of foods and environmental samples. To obtain the broad range of foods claim, the following categories were included in the validation study:

  • Milk and dairy products (raw and heat-processed)
  • Meat and meat products and poultry and poultry products (raw, ready-to-cook and ready-to-eat, ready-to-reheat)
  • Ready-to-cook fish and seafoods and ready-to-eat, ready-to-reheat fishery products
  • Processed fruits and vegetables
  • Bakery products and multi-component foods or meal components

The CertaBlue TVC test is designed to rapidly detect microbial contaminations. An inoculated vial is placed into the AutoScanner System, where it is incubated and monitored in real time. If growth is detected, the sample fails; if there is no detection, the sample passes (i.e., the counts are below the specification limit).

In the validation study, the CertaBlue TVC has been compared to the ISO 4833-1:2013. Although the reference method is generally used to enumerate the level of microorganisms, in this validation it was used to establish if levels of microorganisms exceed the defined threshold of 1 cfu per g for liquid products, 1 cfu per swab for swabs and 10 cfu per g for other products. Thus, a qualitative presence/absence approach with a set presence/absence limit was used, where presence of a single colony (solid and semi-solid products always require a 1:10 dilution step) was equivalent to a “detected” result and absence of a single colony was equivalent to a “not detected” result.

The certificate and the accompanying summary report, number 2021LR94, can be found on the website under ‘issued certificates / alternative methods’.