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.
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.
MicroVal has approved the renewal and extension of the certificate for Assurance GDS Salmonella Tq, manufactured by Merck MilliporeSigma. This molecular based PCR test can be applied for the detection of Salmonella spp. in a broad range of foods and environmental samples.
The Assurance GDS Salmonella Tq was first validated in 2016. The renewal project, based on ISO 16140-2:2016 and the transition guidance document from ISO 16140:2003 to ISO 16140-2:2016, evaluated two additional categories (Poultry products, delicatessen and heat-treated poultry products and muti-component foods) to obtain a broad food claim according to the revised standard. Additionally, an alternative confirmation method for Salmonella was added to the scope based on ISO 16140-6:2019. The renewal and extension study was carried out by Qlaboratories.
The certificate has number 2015LR50 and can be found on the MicroVal website, together with the supporting summary reports.
In June 2020, MicroVal has approved the issuing of the certificate for One Broth One Plate for Salmonella (OBOP-S), manufactured by Neogen. Using traditional culture methodology, OBOP-S offers a rapid method for the enrichment and detection of Salmonella spp in a broad range of food, feed and environmental samples. The certificate results from a validation study performed by the MicroVal expert lab Qlaboratories. The data from this validation study will also be submitted to AOAC International for certification as part of a harmonized validation process. The certificate and the accompanying summary report, number 2019LR88, can be found under ‘issued certificates / alternative methods’.
In March 2020, MicroVal has approved the issuing of a certificate for CompactDry BC, manufactured by Nissui Pharmaceutical. This dry medium for the enumeration of presumptive Bacillus cereus in a broad range of foods was certified based on the results of a validation study, performed by Campden BRI. The certificate and the accompanying summary report, number 2019LR87, can be found here:
Due to the rapid spread of the Coronavirus (COVID-19), IAFP decided to not hold the IAFP European Symposium on Food Safety. MicroVal agrees with IAFP this is the best decision to protect the health and well-being of the participants and attendees. Therefore, MicroVal has decided to postpone the workshop on new developments and future needs of method validation, which is scheduled for Monday 6 April in Munich.
People who have registered for the workshop will receive a personal message to inform them about this change. When the workshop is rescheduled, will be communicated on the MicroVal website and through LinkedIn (linkedin.com/company/microval-nen).
MicroVal organizes a workshop on new developments and future needs of method validation. The workshop will take place in Munich on Monday 6 April 2020, which is one day before the IAFP European Symposium.
As a validation and certification organization, MicroVal often receives novel approaches towards detection methods for validation, which result in fierce and productive discussions during the MicroVal technical committee meetings. The day before IAFP’s European Symposium, MicroVal will open up these discussions for a wider audience, and the IAFP participants in particular, to exchange ideas and knowledge about new developments and future needs for method validation. Topics that will be discussed, are, amongst others, validation of confirmation methods against the recently published ISO 16140-6 and the semi-quantitative approach that gives a qualitative result.
Presentations will be given by Jacques-Antoine Hennekinne (Anses), Joost Witsenburg (MicroVal), Erin Crowley (Qlaboratories), Suzanne Jordan (Campden BRI), Danièle Sohier (Thermo Fischer) and Benjamin Diep (Nestlé).
To consult the full program and /or register for the workshop, click here.
Participation is free, but registration is required.
MicroVal has approved the issuing of the extended certificate for Bruker Daltonics’s MALDI Biotyper for the confirmation of Salmonella spp. The extension study covers the validation of the addition of a fourth C8-esterase agar, which is CASE agar by Neogen.
Previously, the MALDI Biotyper was already validated by MicroVal for the confirmation of Salmonella spp. presumptive colonies isolated from XLD, BGA, 3 Chromogenic agars based on C8-esterase activity detection (RAPID’Salmonella, Brilliance Salmonella and ASAP) and nonselective (NA, TSA).
The MALDI Biotyper Complete Solution (MBT) uses a method based on mass spectrometry for rapid identification of organisms from microbial cultures. The extended validation study assesses the performance of the MBT as a confirmation method to replace the biochemical and serological confirmation procedures outlined in the ISO reference method for colonies isolated on CASE Agar.
The extended validation study has been performed by Campden BRI.
In 2018, MicroVal approved four validation studies against the draft version (DIS) of ISO 16140-6. The four resulting certificates for Bruker Daltonics’s MALDI Biotyper for four different target organisms (Cronobacter spp, Samonella spp, Campylobacter and Listeria spp. & Listeria Monocytogenes) were based on the results of parallel validation studies, performed by the MicroVal expert labs Q Laboratories and ADRIA.
In parallel, the Maldi-Tof system was approved according to AOAC-OMA by AOAC INTERNATIONAL. The MALDI Biotyper was awarded Method of the Year by AOAC International in 2018, and the work received the Best Publication Award in 2019.
MicroVal has approved the inclusion of the vetproof®Salmonella Detection Kit (Product No. V 900 27) in the 2011LR42 certificate.
The vetproof®Salmonella Detection Kit, specifically targeted for the qualitative detection of Salmonella spp. in veterinary / primary production samples, is manufactured by BIOTECON Diagnostics according to the same specifications and components as the foodproof®Salmonella Detection LyoKit. In order to comply with regulations for veterinary diagnostic kits (notifiable disease), it is necessary for it to undergo additional external batch release testing.
The validation study for the foodproof®Salmonella spp. method was performed by ADRIA Développement, France. The method is also PTM approved by the AOAC-RI and NordVal validated. MicroVal certificates can be found on the website here, together with the supporting summary reports. The vetproof®Salmonella Detection Kit is additionally authorized and certified by the German Federal Research Institute for Animal Health (MA No. FLI-C 055, Friedrich-Loeffler-Institut).
MicroVal has approved the issuing of its first certificate for a Shiga toxin-producing Escherichia coli (STEC) detection method. bioMérieux GENE-UP EHEC detection method is validated as an equivalent alternative method to ISO/TS 13136 standard reference method to detect shiga-toxin-producing Escherichia coli (STEC) and the detection of shiga-toxin-producing Escherichia coli (STEC) from O26, O103, O111, O145 and O157 serogroups in raw meat (except poultry), raw milk and raw milk cheeses. The validation was performed by the MicroVal expert lab ADRIA Développement.
The validation of GENE-UP EHEC turned out a very elaborate process. Meat products, by using sample sizes of 25g and 375g, were analysed using 3 different enrichment protocols of which 2 with a short enrichment time. For the detection of STEC from O26, O103, O111, O145, and O157 serogroups, two extraction procedures before the PCR assays were included in the study: a mechanical cell disruption procedure (bead-beating) and the VIDAS® ESPT assay for the specific immunocapture of the targeted serogroups.
For confirmation of positive PCR assays, in addition to a direct isolation procedure on selective agars, the VIDAS® ESPT assay was also used to facilitate the recovery of the specific strains by limiting the background flora on selective agars. The multiplication of enrichment, extraction and confirmation protocols made this study highly challenging but comprehensive with more than 4,000 alternative PCR assays for the screening step. And finally, the interlaboratory study included 17 collaborators from 14 laboratories. Each collaborator performed the whole method from sample treatment to the final confirmation step.
Shiga toxin-producing Escherichia coli (STEC) are an important cause of food-borne illness. These pathogens can be responsible for gastrointestinal diseases ranging from diarrhea to haemorrhagic colitis and haemolytic uremic syndrome. As a result, the food industry needs fast, sensitive and complete methods for STEC detection to ensure a safe food supply. The certificate, number 2018LR84, can be found on the MicroVal website , together with its supporting summary report.