Tag: Bio-Rad

New certificate for iQ-Check EB for the detection of Enterobacteriaceae

MicroVal approved the issuing of a new certificate for iQ-Check EB for the detection of Enterobacteriaceae, manufactured by Bio-Rad Laboratories. As indicated by its name, this method is designed for the detection of Enterobacteriaceae in infant formula, infant cereals (with or without probiotics), and related ingredients with test portion up to 375 grams.

The study was performed by ADRIA, and conducted in accordance with ISO 16140-2:2016 and ISO 16140-2/A1:2024. The validation covered the following components:

  • iQ-Check Enterobacteriaceae kit
  • FDRS
  • CFX96 Deep Well and CFX Opus Deep Well PCR instruments

The method involves enrichment of samples in prewarmed Buffered Peptone Water (BPW) with a PIF supplement, followed by FDRS treatment, lysis, and PCR analysis. Positive PCR results are confirmed using either the reference method (ISO 21528-1:2017) or the alternative method based RAPID Enterobacteriaceae agar, where the presence of typical colonies confirms the result.

This validation confirms the reliability, robustness, and applicability of the iQ-Check EB method for detecting Enterobacteriaceae  in sensitive food matrices intended for infants.

An extension of the validation was approved in June 2025 for use with the updated CFX Maestro IDE software (version 4.0).

The certificate and the detailed summary report, number 2018LR80, are available on our website.

Microval welcomes two new MicroVal General Committee Members

MicroVal is happy to welcome two new members of the MicroVal General Committee (MGC). Yannick Bichot (Bio-Rad Laboratories) and Frédéric Martinez (Neogen Corporation). With them, there are currently 16 members in the MGC.

The MGC is responsible for setting up standardized procedures, complementary to ISO 16140-2 and ISO 16140-6, for conducting the validation studies and to make sure that those validation studies stay in line with current legislation. In addition, the MGC promotes MicroVal in order to attract new validation assignments. All MGC members participate on a voluntary basis originating from different relevant backgrounds like food safety, regulatory affairs and standardization, method validation, and certification. 

Organizations represented in the MGC are of Nestle (Switzerland), Hygiena (Germany), bioMérieux (France), Eurofins (USA), Neogen Corporation (USA), Merck KGaA (Germany), Anses (France), ADRIA Developpement (France), Post Consumer Brands (USA), NVWA (The Netherlands), LRQA (The Netherlands), R-Biopharm AG (Germany), Bio-Rad Laboratories (France), and Liaison members of AOAC International (USA) and NordVal (Scandinavia and Baltics).

Contact details can be found on this page 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’.