Category: EN – newsitem

First certificate for FOSS BactoScanTM5

In January 2025, MicroVal granted another certificate, this time for the FOSS BactoScanTM5. The BactoScanTM5 is FOSS’ latest generation fully automated flow cytometry-based instrument dedicated to quantify the Total Bacterial Count (TBC) in raw milk.

Building on the legacy of previous generations, the new innovative BactoScan 5 allows milk testing laboratories to analyze raw milk more efficiently and with an unprecedented level of safety, making it easier than ever before to improve food safety and ensure milk quality. One of the key drivers behind these improvements is a new reagent concept that significantly reduces the amount of operator steps and the time spent on reagent preparation, and also responsibly reduces the use of chemicals, and waste. This means improved productivity and business. For more information: Boost Productivity with BactoScan™ 5 Milk Bacteria Analyzer.

The validation study was conducted by Actalia Cecalait, a MicroVal expert laboratory. Actalia evaluated the instrument according to ISO 16140-2:2016, ISO 16297:2020, and ISO 21187:2021 standards, as well as the criteria defined in the EURL MMP document “Criteria for the validation of instrumental (epifluorescent) methods for the determination of total flora in raw milk” from December 2011. In the second part of the study, the instrument was compared to the already validated certified BactoScanTM FC+. For more information, see the detailed summary report and certificate number 2013LR45).

The certificate and the detailed summary report of this current study, number 2024LR133, are available on our website.

First certificate for D-COUNT

MicroVal has approved the issuance of the certificate for BioMérieux’s D-COUNT. Microsept conducted the validation study to determine the commercial sterility of UHT-treated milks and UHT plant-based drinks.

D-COUNT Commercial Sterility Testing utilizes flow cytometry technology to detect all viable microorganisms in a sample through viability labeling and fluorescence detection. This rapid detection method involves a simple four-step process: The first 2 steps outside the system are product pre-incubation and sample preparation, following dedicated protocols. Then the products are transferred into the system for analysis. The analysis consists of cell labeling and cell counting, before displaying the results.

Microsept adhered to ISO 16140-2 as the validation standard and used the Codex Code of Hygienic Practice for Milk and Milk Products (CAC/RCP 57-2004) as the reference method. Specifically, they followed Appendix B: Microbiocidal Control Measures, Section 2.2: Process Management for UHT Treatment, using ISO 4833-1:2013 for the plate count at 30°C. The validation scope includes UHT-treated milks and UHT plant-based drinks.

The certificate and detailed summary report (number 2023LR126) are available on our website.

First certificate for InviScreen ® Salmonella spp. Detection Kit

A first MicroVal certificate in 2025 has been issued. In January 2025, MicroVal approved the issuance of a certificate for InviScreen® Salmonella spp. Detection Kit, supplied by Invitek Diagnostics. The validation of this detection kit was conducted by Q Laboratories.

The reference methods used were ISO 6579-1:2017 and ISO 6579-1:2017/Amd 1:2020, following the guidance of ISO 16140-2:2016. The validation scope covers a broad range of food claim and includes the following 6 categories:

  • Heat Processed and Raw Milk and Dairy Products (25 g)
  • Raw and Ready-to-eat (RTE) Meat Products (25 g)
  • Raw Poultry Products (25 g)
  • RTE and RTRH Poultry Products (25 g)
  • Eggs and Egg Products (25 g)
  • Fresh Produce and Fruits (25 g)

The InviScreen® Salmonella spp. Detection Kit enables real-time PCR detection of Salmonella spp. in a wide variety of food products, providing same-day results for all validated matrices. The method consists of four steps: enrichment, DNA extraction, real-time PCR detection, and interpretation of results. The real-time PCR assay can be performed using two commercially available real-time PCR instruments equipped to detect fluorescence emissions in the FAM and VIC or HEX channels.

The certificate and the validation report (2023LR127) can be found on our website.

MicroVal Recap Edition 2024

With 2024 coming to an end, MicroVal reflects on a year of significant achievements and growth.

Team Expansion: This year, we welcomed three new members to our team: Leah Zitman, Yolanda Noort, and Eric Kamst, who have joined Joost Witsenburg and Suzanne de Jong in strengthening our secretariat. Additionally, we expanded our MVTC with four new members, bringing the total to 29.

International Presence: MicroVal actively participated in international events, presenting at the IAFP conference in Geneva and the AOAC conference in Baltimore. These platforms allowed us to introduce MicroVal, share success stories of manufacturers who validated their test kits with us, and present the link to legislation, cooperation with AOAC, and larger test portion sizes.

Certification Milestones: Thirteen MicroVal certificates have been issued to Shimadzu Diagnostics Corporation, Merck MilliporeSigma, Neogen Corporation, Kikkoman Biochemifa Company, Foss Analytical A/S, and Hygiena Diagnostics GmbH. Congratulations to all for achieving these certifications!

New Initiatives: We launched the MicroVal Community, an informal network for anyone interested in the validation of alternative microbiological methods. Additionally, we introduced MicroVal Rules 9.4, which includes validation against EN-ISO 16140-7, the establishment of working groups, and an emergency validation protocol.

We extend our heartfelt thanks to everyone involved in our journey this year. Wishing you a wonderful holiday season and a happy new year 2025!

New MicroVal Rules Published

As the year 2024 draws to a close, the MicroVal secretariat and the MicroVal General Committee (MGC) have been updating the MicroVal Rules. Today we publish the new rules, version 9.4. They replace the previous version published earlier this year.

Key Updates in Version 9.4:

  1. Validation Against EN-ISO 16140-7: MicroVal now supports the validation of identification methods of microorganisms.
  2. Establishment of Working Groups: Under the Technical Committee (MVTC), MicroVal can now form working groups with specific tasks or expertise, such as the Working Group Milk.
  3. Emergency Validation Protocol: In response to potential future crises, MicroVal has introduced an emergency validation protocol to be able to quickly support the food industry.

The document details these updates as follows:

  • Validation against EN-ISO 16140-7: Integrated throughout the document.
  • Working Groups: Clause 5.2.8.
  • Emergency Validation Protocol: Clause 9.11 and Annex C.

Experts from various organizations contributed to drafting the MicroVal Rules, including 3M Food Safety, ADRIA Développement, Anses, bioMérieux, Bio-Rad, Campden BRI, Cargill, Eurofins, Hygiena, LRQA, Merck KGaA, MXNS, Neogen, Nestle, NEN, NVWA, Post Holdings, R-Biopharm AG, and Thermo Fisher Scientific.

The document is available here.

MicroVal thanks everyone involved for their outstanding work!

The MicroVal Community is now live on LinkedIn

The MicroVal Community is now an open discussion group on LinkedIn!

This is an informal community where any person or organization (e.g. regulatory bodies, certification bodies, standardization organizations, method manufacturers, expert-, routine-, reference laboratories and food business operators) with interest in validation of alternative microbiological methods can be part of.

What’s different compared to the already existing MicroVal page? In the Community group everyone can post as well as reacting to posts. The group for instance allows you to:

  • Discuss topics on method development, validation, and standardization with a large international group of experts
  • Let the community know what conferences you will attend, so you can meet up.

Please share this announcement in your network and join the community!

MicroVal Renews Certification for Hygiena’s foodproof® Salmonella Detection Kit

MicroVal has renewed the certification for Hygiena Diagnostics GmbH’s foodproof® Salmonella Detection Kit (Cat. No. R 310 27 or R 302 27), combined with Reagent D (Cat. No. A 500 02) and foodproof® StarPrep One Kit (Cat. No. S 400 07) or foodproof® Magnetic Preparation Kit IV (Cat. No. S 400 15) for DNA extraction. It is designed for reliable detection of Salmonella spp. and is intended to be used in combination with the foodproof ® Enterobacteriaceae plus Cronobacter Detection Kit (Cat. No. R 310 15.1 or R 302 15.1) for infant formulae and related matrices. Both kits were validated in a joint study.

Initially validated in 2012, the kit meets the rigorous standards set by EN ISO 16140-2:2016, with reference method ISO 6579-1:2017. It is certified for use in testing infant formula and infant cereals, probiotics containing products, ingredients, and environmental samples.

The certificate and summary report are available on the MicroVal website under study number 2011LR39.

 

Extension certificates Bentley Instruments BactoCount IBC 3.0 & BactoCount IBCm 3.0 issued

MicroVal certified an extension study for the Bentley Instruments BactoCount IBC 3.0 & BactoCount IBCm 3.0 devices. These devices measure total bacterial count (TBC) and somatic cell count (SCC). Initially validated in 2022 for raw cow’s milk, they are now certified for raw goat’s and sheep’s milk as well. Both validation studies were conducted by ACTALIA Cecalait.

The BactoCount IBC 3.0 & BactoCount IBCm 3.0 can offer simultaneous real-time analysis of TBC and SCC in raw milk with a flow cytometer, but in the frame of this validation, TBC and SCC were tested separately. The validation scope covers only the separate use of TBC and SCC.

The extension studies were done according to ISO 16297, ISO 21187, and ISO 16140-2 for TBC and according to ISO 8196-3, ISO 13366-2, and ISO 16140-2 for SCC, using ISO 4833-1 and ISO 133366-1 as reference methods. Results obtained for TBC were also compared with the limits defined in the EU-RL document. The programs used to analyze sheep’s and goat’s milk are the same as for cow milk (ratio milk/reagent, type of reagent, incubation time, and protocol).

Both certificates 2021LR97 and 2021LR98 can be found on our website.

Certification for Neogen’s Soleris Non-Fermenting Total Viable Count (NF-TVC)

In September, MicroVal granted certification for Non-Fermenting Total Viable Count (NF-TVC). NF-TVC is a series of Soleris manufactured by Neogen. NF-TVC detects total viable count at a threshold of 10 cfu per gram across a wide variety of food products.

The NF-TVC vial, containing 9 mL of broth, is designed for dilute-to-specification monitoring in diverse food matrices. As microorganisms grow in the medium, the carbon dioxide produced diffuses through a membrane into a soft agar plug with a dye indicator, resulting in a color change that is analyzed by the Soleris® instrument.

The detection time correlates with the contamination level, allowing for quicker results with higher levels of contamination. This validation aims to establish a rapid screening method for increased throughput in monitoring various food products, thus reducing both analysis time and time to results.

Campden BRI conducted the validation study in accordance with ISO 16140-2:2016, using ISO 4833-1:2013 as a reference method. The study encompasses a broad range of food categories, including dairy, fishery products (raw and ready-to-cook), fresh and processed produce, multicomponent foods, and meat and poultry products (raw and ready-to-cook).

The certificate and the detailed summary report, number 2022LR113, are available on our website.

Microval welcomes a new MicroVal Technical Committee Member

Last July, MicroVal announced the addition of three new members to its Technical Committee (MVTC). This month, MicroVal is pleased to welcome another new member: Stephen Antonie-Zijlstra from FrieslandCampina. With his appointment, the MVTC now comprises 29 members.

As an MVTC member, candidates are expected to have expertise in microbiological reference and alternative methods, an area where Stephen excels. He brings extensive experience in scouting, validating, and verifying various microbiological methods, as well as in assessing their performance in routine laboratory work. Additionally, he has been involved in the validation and verification of alternative methods prior to their implementation in his lab. Stephen is also an active participant in several ISO working groups and International Dairy Federation (IDF) Action Teams. The current MVTC members believe he will contribute valuable insights, particularly in the ISO 16140-2 validation studies of alternative microbiological methods.

The MVTC consists of Campden BRI (UK), Merck Life Science / MilliporeSigma (USA), Danone (France), ADRIA (France), Nestlé (Switzerland), Mérieux NutriSciences – Global (USA), Hygiena (France), bioMérieux (Spain), Q Laboratories (USA), TLR International Laboratories (The Netherlands), Laboratoire Microsept  (France), Neogen Corporation (France), FDA (USA), Thermo Fisher Scientific (UK), Eurofins WFC (The Netherlands), AOAC INTERNATIONAL consultant (USA), NVWA (The Netherlands), LRQA (The Netherlands), Actalia (France), Bio-Rad Laboratories (France), IEH Laboratories and Consulting Group (USA), and FrieslandCampina (The Netherlands).

Contact details can be found on this page on our website.