Renewed certificates GENE-UP E.coli O157:H7 and Compact Dry ETC

MicroVal has renewed the certificates for bioMérieux ‘s GENE-UP E.coli O157:H7 and Nissui’s Compact Dry ETC. Both certificates are now valid until April 2025.

GENE-UP E.coli O157:H7 2 (ECO and ECO 2) is a real-time Polymerase Chain Reaction (PCR) assay for the qualitative detection of E.coli O157:H7 in food samples. The method was first validated by th expert lab ADRIA Développement in 2017. The scope of the validation consisted of fresh and frozen raw meats, cured and fermented meats, vegetables, raw dairy products using a specific protocol, raw meats (except poultry) using a short protocol (25 g and 375 g sample size) and environmental samples. The renewed certificate, registered as study number 2015LR59, can be retrieved form the MicroVal website, together with the supporting validation report.

Compact Dry ETC is a ready to use, selective and chromogene plate for the detection and enumeration of Enterococcus. The method was first validated by the expert lab Campden BRI in 2017 for the scope of broad range of foods. The renewed certificate, registered as study number 2014LR48, can be retrieved form the MicroVal website, together with the supporting validation report.

MicroVal Expert opinion about AOAC Validation Coronavirus Test Kits

AOAC INTERNATIONAL announced that it has issued five certificates of validation for proprietary test kits that detect SARS-CoV-2 on stainless steel surfaces. These test kits have passed the evaluation required by the globally recognized AOAC Research Institute’s Performance Tested Methods (AOAC-PTM) Program, which implemented an Emergency Response Validation (ERV) process to accelerate the evaluations. The MicroVal experts have evaluated the approaches taken by the AOAC-PTM validation program for detection methods of the SARS-CoV-2 on environmental surfaces, and fully support this AOAC initiative.

Below you can find some more information from AOAC on this program.

The COVID-19 crisis has fundamentally changed our way of life and the everyday life in the professional and domestic environments. It is obvious this will have other impacts in the future.

SARS-CoV-2 is a public health issue. Direct transmission of the virus from person-to-person is the main route of contamination. However, some food industries have faced contamination issues among co-workers[1]; stability of SARS-CoV-2 on various surfaces have been demonstrated[2], and transmission of the virus from contaminated surfaces might be possible[3].

Emergency responses were set up to support the food industry. Methods have been developed to detect SARS-CoV-2 in food production environment to evaluate the efficiency of control measures designed to eliminate the virus from surfaces. AOAC INTERNATIONAL has activated an accelerated program to evaluate test kits for detecting coronavirus on surfaces.

For food manufacturers, contract laboratories, and others in the food supply chain, the certifications provide independently validated tests they can use to ensure their

sanitation protocols are effective and to provide a culture of safety for their essential employees.

The AOAC Performance Tested Method program (PTM) includes multiple steps:

  • An in-silico analysis was developed to evaluate the quality of the primers and probes of the test kits. This innovative approach in the framework of method validation makes sense as thousands of SARS-CoV-2 genomes are free available, and the databases continue to expand.  In the validation study, there were 15,764 accessions evaluated for inclusivity, and 65 near neighbors and environmental background organisms for exclusivity.
  • The matrix study was run with stainless steel test areas inoculated with intact SARS-CoV-2 virus (USA_WA1/2020). The samples were prepared by a single independent laboratory. After proper surface sampling, the US Centers for Disease Control and Prevention (CDC) method and the candidate method were run in an unpaired data study design to attempt to detect the virus on the surfaces. The acceptability of the alternative method is evaluated by the Probability of Detection approach[4].
  • The Robustness, Product Consistency and Stability studies will be run in a final step early 2021, as kits from different production batches are required. Robustness parameters evaluated will be specific to each method.

The involved AOAC reviewers are recognized experts in the field.

AOAC Volunteer Expert

William Burkhardt, FDA/CFSAN/OFS/DSST

AOAC Expert Reviewers

Jacqueline Woods, FDA/CFSAN/OFS/DSST/MHSB

Efi Papafragkou, FDA/CFSAN/OARSA

Sanjiv Shah, EPA/ORD/HSMMD

John SantaLucia, Wayne State University

Chengzhu Liang, Qingdao Customs District Laura Rose, CDC/DDID/NCEZID/DHQP


[1] https://www.newfoodmagazine.com/article/112889/coronavirus/

[2] https://www.forbes.com/sites/robertglatter/2020/08/23/covid-19-coronavirus-can-survive-on-frozen-meat-and-fish-for-up-to-3-weeks-study-finds/#1e8975128877

[3] https://doi.org/10.1016/j.tifs.2020.08.020

[4] http://www.eoma.aoac.org/app_h.pdf

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.

Renewed and extended certificate for GDS Salmonella Tq

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.

Certificate issued for OBOP-Salmonella

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’.

New certificate for CompactDry BC

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:

https://microval.org/en/issued-certificates/

Postponement MicroVal workshop

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 workshop on new developments and future needs of validation methods

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.

Onderschrift

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.

Practical information:

  • Date: 6 April 2020
  • Time: 13.00-17.00 hrs
  • Location: Holiday Inn City Centre, Munich (DE)

Certificate MALDI Biotyper Salmonella spp. extended with addition CASE agar

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.