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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

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[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

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:

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

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.

Practical information:

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

 

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).