Tag: STEC

MicroVal Validation confirms performance of NEOGEN® Molecular Detection Assay 2 for STEC

A MicroVal validation study conducted by ADRIA has successfully evaluated the NEOGEN® Molecular Detection Assay 2 for the detection of Shiga-toxin-producing Escherichia coli (STEC) and Shiga-toxin gene (stx1 and stx2) and intimin gene (eae) from Shiga-toxin-producing E. coli STEC. The study was performance in accordance with ISO 16140-2 & ISO 16140-2/A1:2024 with ADRIA internal method based on ISO/TS 13136 (November 2012) as reference method. The study covered raw meat (except poultry) as well as fresh produces and fruits.

The validation scope included two alternative methods:

  • NEOGEN® Molecular Detection Assay 2 – STEC Gene Screen (stx)
  • NEOGEN® Molecular Detection Assay 2 – STEC Gene Screen (stx and eae)

After standardised enrichment steps using pre-warmed Buffered Peptone Water (BPW), DNA extraction was performed with the NEOGEN Lysis Solution, followed by LAMP-based detection targeting stx alone or stx and eae genes. Confirmation of presumptive results was carried out by direct streaking on selective agar and molecular confirmation using the same NEOGEN® assays.

Results demonstrated that the NEOGEN® Molecular Detection Assay 2 provides a reliable and efficient alternative method for STEC detection across a broad range of food matrices. This validation reinforces the suitability of NEOGEN® Molecular Detection Assay 2 as a robust tool to support food safety testing and regulatory compliance for STEC monitoring.

The certificate and the detailed summary report, number 2020LR92, are available on our website.

Renewed certificate for iQ-Check STEC VirX

In December 2022, MicroVal has approved the issuing of the renewed certificate for Bio-Rad’s  iQ Check STEC VirX, based on the extension validation study to include food products based flours and raw doughs within the scope. Like the initial validation study, also the extension study was carried out by ADRIA Développement.

The iQ-Check STEC VirX for real-time PCR detection of virulence genes in Shiga toxin-producing Escherichia coli has now been validated for raw dairy products, raw meat products (excluding poultry) and flours and raw doughs. In general, this method gives the results for both stx and eae genes, however for this validation study, the interpretation was based on detection of stx only.

The certificate and the accompanying validation report, number 2021LR96, can be found under ‘issued certificates / alternative methods’.

New Certificate for iQ-Check™ STEC VirX

In June 2022, MicroVal has approved the issuing of the certificate for Bio-Rad’s iQ-Check™ STEC VirX kit for real-time PCR detection of virulence genes in Shiga toxin-producing Escherichia coli. ADRIA Développement has carried out the validation study of this alternative method, based on ISO 16140-2:2016, for the scope of raw meat products (excluding poultry) and raw dairy products.

STEC outbreaks are commonly associated with the consumption of raw meat, particularly beef, but also with dairy products. A sample positive for both stx1/stx2 and eae targets typically requires further testing for the identification of the major E. coli serogroups. The iQ-Check STEC VirX Kit, based on a multiplex real-time PCR system, allows the detection of the stx1/stx2 and eae virulence genes within a few hours after microbiological enrichment.

The certificate and the accompanying validation report, number 2021LR96, can be found under ‘issued certificates / alternative methods’.