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.
MicroVal has approved the renewal of the certificate for BactoScanTM FC and FC+, manufactured by Foss Analytical A/S. BactoScanTM FC/FC+ gives an accurate determination of the hygienic quality of raw milk with a capacity of testing up to 200 samples per hour.
BactoScanTM FC/FC+ was first validated in 2015. The validation study, then, was performed by Qlip, who have also been involved as expert lab in the renewal procedure. The validation has been performed in accordance with ISO 16140-2 and the EURL MMP document on the validation criteria of instrumental methods for enumeration of total flora in raw milk (Dec. 2011)
The certificate has number 2013LR45 and can be found on the MicroVal website, together with the supporting summary reports.
We are happy to welcome two new MicroVal Expert Laboratories: Laboratoire MicroSept (France) and WFC-Food Safety (The Netherlands). With that we now have eight labs that perform MicroVal validation studies.
A MicroVal expert lab is in charge of the co-ordination and supervision of the three phases of the validation procedure: (1) the development of the validation protocol, (2) the method comparison study of the alternative method against the reference method and (3) the interlaboratory study of both methods.
MicroVal has approved the renewal and extension of the certificates for the foodproof®Salmonella spp. method, manufactured by BIOTECON Diagnostics for the qualitative detection of Salmonella spp. in foods, feed and primary production samples.
The foodproof®Salmonella spp. method was first validated in 2013 with an automated (certificate 2011LR40) and a manual sample preparation protocol (certificate 2011LR42). Within the renewal study, the certificates were extended for the lyophilized version of the kit – the foodproof®Salmonella Detection LyoKit. The study was performed by ADRIA Développement, France.
MicroVal has approved the renewal of the certificate for Compact Dry TC, manufactured by Nissui Pharmaceutical Co. Ltd and Supplied by HyServe GmbH. Compact Dry TC enumerates total viable organisms in a broad range of foods.
We are proud that the first ever MicroVal certificate to be issued will be valid for at least another four years. Compact Dry TC was first validated twelve years ago in 2007. The renewal study was performed by Campden BRI.
MicroVal has just issued the first certificate for Neogen’s Soleris Enterobacteriaceae, based on a semi-quantitative validation for detection of Enterobacteriaceae at a threshold of <10cfu/ml. The study was conducted by Campden BRI.
This novel approach was designed to meet a specific legislative requirement in EU 2073 for the presence of Enterobacteriaceae in dairy products at a level of <10cfu/ml. Historically, ISO 16140-2:2016 validation studies have either been quantitative i.e. based on enumeration of microorganisms in the test samples, or qualitative, i.e. based on detecting the presence or absence of a target microorganism in a test sample. This semi-quantitative study design compared the results from the enrichment of a test sample in the Neogen Soleris system using the S2-EBAC9 Enterobacteriaceae vial with the results from the reference method which uses a plating method. The unique part of this validation was the use of a single plate of the reference agar where the absence of any colonies was equivalent to detection of <10cfu/ml and the presence of one or more colonies was equivalent to detection of >10cfu/ml. Hence the approach used a plate count method as a qualitative result and not a quantitative result.
This semi-quantitative approach could have a wide application to many other microbiological test methods which use a dilute to specification approach to show compliance with a target threshold of, for example, <10cfu/ml or <100cfu/ml.
The certificate for Neogen’s Soleris Enterobacteriaceae can be found by the number 2018LR83.
In September 2019 MicroVal has approved the issuing of the certificate for HyServe’s Compact Dry PA, the ready to use plate for enumeration of total Pseudomonas aeruginosa (PA). This is the first MicroVal certificate for a enumeration method to be used within the field of water intended for human consumption. The certificate is based on the results of a validation study in accordance with ISO 17994:2014 and ISO 16140-2:2016, which has been performed by Campden BRI. The certificate can be found by the number 2017LR66. The Compact Dry plates are manufactured by Nissui Pharmaceutical CoLtd and supplied by HyServe.
Moreover, the certificate for HyServe’s CompactDry YM for the enumeration of yeasts and moulds in a broad range of foods, which was originally issued in 2011, has been successfully renewed, based on the validation study according to ISO 16140-2:2016 by Campden BRI. The certificate has number RQA2008LR10.