New Certificate for SureTect Salmonella Species PCR Assay

MicroVal has approved the issuing of the certificate for ThermoFisher Scientific’s SureTect Salmonella Species PCR Assay. Q Laboratories carried out the extension validation study for a broad range of foods in which the use of pre-warmed (41.5 or 37 ± 1 °C) BPW ISO as the primary enrichment media was evaluated, in addition to alternative sample sizes.

The Thermo Scientific SureTect Salmonella Species PCR Assay was originally validated by AFNOR according to the ISO 16140:2003 standard in 2013. Multiple extension studies were conducted since the initial validation study, and the first renewal validation enabled alignment with the revised ISO 16140 – 2:2016 standard in 2017. The method is validated for the use of three instruments: Applied Biosystems 7500 Fast, Applied Biosystems Quantstudio 5 and the PikoReal instrument. A summary of the initial validation, original renewal, and previous extension studies can be found on the available summary report (AFNOR Certificate: UNI 03/12-01/18).

All data generated from the three claimed thermocyclers for each matrix claimed under the AFNOR Certificate: UNI 03/12-01/18 was presented in a Gap Analysis report to the MicroVal Technical Committee (MVTC) according to the MicroVal Rules set up by the MicroVal General Committee (MGC). The MVTC agreed that the supporting data on the three different cyclers covered a broad range of foods, thus meeting the MicroVal requirements needed for the method to be transferred to become MicroVal 2022LR111. It should be noted that both Applied Biosystems 7500 Fast and QuantStudio 5 thermocyclers are included in the extension claims in opposite to the PikoReal instrument that was used in the ILS portion of the original validation.

The summary report of the extension validation study, available on the MicroVal website, provides an overview of the categories and sample sizes that were included in the final scope, as well as the instrumentation that was validated for use in this extension. The certificate and the accompanying summary report, number 2022LR111, can be found under ‘issued certificates / alternative methods’.

New ISO 16140-6 validation for Check&Trace Salmonella 2.0

MicroVal has approved the issuing of the certificate for Check-Points’s Check&Trace Salmonella 2.0. WFC Analytics carried out the validation study, based on ISO 16140-6, for an alternative method for the confirmation and typing of Salmonella spp. Following from the validation study, the Check&Trace Salmonella 2.0 (CTS 2.0) is considered equivalent to the reference method (ISO 6579-1 and ISO 6579-3) for the confirmation of presumptive Salmonella spp. isolated on non-selective NA and selective XLD and for typing of 59 Salmonella serovars.

The Check&Trace Salmonella 2.0 Assay is a qualitative, semi-automated real-time PCR test designed for the confirmation and typing of presumptive Salmonella isolates from enriched culture media. The confirmation procedure advances a suspected (presumptive) Salmonella result to a confirmed Salmonella spp. result or a Salmonella negative result. The typing procedure generates a serovar result or a “genovar” code both uniquely defining each bacterial isolate tested.

DNA typing differs from serotyping. With serotyping the presence of antigens on the cell surface and flagella are detected. This is based on expression of genes located on two specific segments of the Salmonella genome. The CTS 2.0 assay detects genetic variation at 21 loci scattered over the whole Salmonella genome: this generates specific Salmonella genotypes, also called Genovars. The CTS 2.0 database links Genovars to a collection of well-characterized Salmonella Serovars. A Genovar will be given as test result if there is no established Serovar for the Genovar generated by the CTS 2.0 assay.

Check&Trace Salmonella 2.0 is considered equivalent to the ISO standard (ISO/TR 6579-3:2014) for typing of 59 Salmonella serovars. The full list of Salmonella serovars is given in the certificate and validation report, available on the MicroVal website under ‘issued certificates / confirmation methods’.

New certificate for foodproof Enterobacteriaceae plus Salmonella Detection LyoKit – 5’Nuclease

MicroVal has approved the issuing of the certificate for BIOTECON diagnostics GmbH’s foodproof Enterobacteriaceae plus Salmonella Detection LyoKit – 5’Nuclease. The validation study is carried out ADRIA Développement and is based on ISO 16140-2:2016.

The foodproof Enterobacteriaceae plus Salmonella Detection LyoKit – 5’Nuclease is a PCR kit for the qualitative detection of Enterobacteriaceae plus simultaneous identification of Salmonella spp. DNA using real-time PCR instruments. The validation of this alternative method has been performed in combination with the foodproof StarPrep One Kit and the foodproof StarPrep Three Kit in both single tube and 8-strip formats. For this validation study the following categories were tested:

  • infant cereals,
  • infant formula with or without probiotics and ingredients
  • production environmental samples.

The certificate and the accompanying study report, number 2020LR90, can be found under ‘issued certificates / alternative methods’.