Renewed and extended certificate for Assurance GDS E. coli 0157:H7 Tq

In October 2020, MicroVal has approved the renewal and extension of the certificate for Assurance GDS E. coli 0157:H7 Tq, manufactured by Merck MilliporeSigma. This genetic detection system is an automated nucleic acid amplification system for the detection of pathogenic E. coli 0157:H7 in foods, ingredients and environmental samples. The renewal and extension study was conducted by Qlaboratories.

The Assurance GDS E.coli 0157:H7 Tq was first validated in 2016. For the renewal project, all data was reanalysed according to the statistical guidelines outlined in ISO 16140-2:2016 to determine if the acceptance criteria were met.

An additional alternative confirmation method for E. coli O157:H7 was also added to the scope. Necessary supplemental testing was conducted following a sensitivity outline for the categories that are already claimed following ISO 16140-6: 2019.

The renewed and extended certificate, registered as study number 2015LR49, can be retrieved form the MicroVal website, together with the supporting validation report.

Certificate GENE-UP EHEC extended

MicroVal has approved the extension of the certificate for GENE-UP EHEC, developped by bioMérieux. GENE-UP EHEC is a method for the detection and confirmation of EHEC in raw meat (except poultry), raw milk and raw milk cheese and environmental samples with GENE-UP PCR reagents. The validation study has been conducted by the MicroVal expert lab ADRIA Développement.

GENE-UP EHEC was first validated in December 2019. The extension project consisted of the extension of the scope to include raw dairy products using a protocol for bead beating extraction and the production of environmental samples for the VIDAS ESPT assay.

The extended certificate has number 2018LR84 and can be retrieved from the MicroVal website, together with the study report.