Category: EN – newsitem

New certificate issued for Autobio Diagnostics’s method

MicroVal has approved the issuing of a new certificate for the Autof ms1000 method developed by Autobio Diagnostics Co., Ltd. This certificate is based on a validation study performed by Q Laboratories.

The Autof ms1000 is a mass spectrometry system designed for the confirmation of isolated colonies of bacteria, yeasts, and molds from various agar media. The system uses Matrix Assisted Laser Desorption/Ionization Time-of-Flight (MALDI-TOF) technology to identify microorganisms based on their unique ribosomal protein patterns. This “soft ionization” technique employs a liquid matrix, typically α-Cyano-4-hydroxycinnamic acid (CHCA), to gently ionize large biomolecules with minimal fragmentation. The resulting ions are analyzed by their mass-to-charge ratio (m/z), producing a distinct spectral fingerprint for each organism.

Identification is achieved by comparing the test organism’s mass spectrum to a reference library containing spectra of known organisms. The Autof ms1000 software then provides a probability-based identification according to the degree of spectral similarity.

The MicroVal validation was conducted in accordance with ISO 16140-6:2019, using ISO 22964:2017 as the reference method. The evaluation covered the confirmation of Cronobacter spp. at the genus level, using Autof ms1000 software version 2.2.157.

The study included both selective and non-selective (reference) agar media:

  • Selective agars: Cronobacter Chromogenic Isolation Agar (CCI), Brilliance Cronobacter Sakazakii Agar (DFI formulation), and HardyCHROM Sakazakii (HCCS).
  • Non-selective agar: Tryptic Soy Agar (TSA) — Hardy Diagnostics.

The certificate and full validation report are available under the number 2023LR117.

First certificate for SureFast® Listeria 3plex ONE Kit and the SureFast® PREP Bacteria Kit

MicroVal has approved the issuance of the certificate for the SureFast® Listeria 3plex ONE Kit and the SureFast® PREP Bacteria Kit, developed by Congen Biotechnologie GmbH. The study is being conducted by Q Laboratories.

The SureFast® Listeria 3plex ONE Kit enables real-time PCR detection of Listeria species and Listeria monocytogenes in food and environmental samples. The kit can also be used in combination with the SureFast® PREP Bacteria Kit, offering an alternative DNA extraction option. 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 commercially available PCR instruments equipped to detect four fluorescence channels OX, Cy5, VIC, and HEX simultaneously.

The validation has been conducted in accordance with ISO 16140-2:2016 and the reference methods ISO 11290-1:2017 and ISO 6887 (Parts 1–5). The study covers the detection of Listeria spp. and Listeria monocytogenes in a broad range of foods and environmental samples, including:

  • Heat-processed and raw milk and dairy products
  • Raw and ready-to-eat (RTE) meat products
  • RTE poultry products
  • RTE and ready-to-reheat (RTRH) fishery products
  • Fresh produce and fruits
  • Multi-component foods or meal components
  • Environmental samples

This validation confirms the performance of the SureFast® Listeria 3plex ONE Kit and SureFast® PREP Bacteria Kit as reliable alternatives for the detection of Listeria spp. and Listeria monocytogenes across diverse food and environmental matrices.

The certificate and detailed summary report (number 2023LR114) are available on our website.

AOAC & MicroVal Method Validation Training – Microbial Method Validation: Detailed Insights

We’re thrilled to invite our network to Session 2 of the 2025 AOAC & MicroVal Method Validation Training – Microbial Method Validation: Detailed Insights, organised by AOAC Southeast Asia (AOAC SEA) in collaboration with AOAC INTERNATIONAL and MicroVal.

  • When: 10 September 2025, 11:00 – 14:00 (GMT+8)
  • What’s inside: LOD & POD concepts, appendices, validation elements, verification pathways
  • Who should join: Lab professionals, method developers, regulatory stakeholders
  • Registration: Free for AOAC SEA members (use code MWG2025). Deadline: 9 September 2025, 16:00 (GMT+8)

Register now! Link

New certificate Autof ms1000 Method for confirmation of Salmonella spp.

MicroVal approved the issuing of a certificate for Autof ms1000 method from Autobio Diagnostics Co, Ltd. This method is a mass spectrometer system using Matrix Assisted Laser Desorption/Ionization Time-of-Flight (MALDI-TOF) for the confirmation of isolated colonies of bacteria, yeasts, and molds from a variety of agar media.

Q Laboratories performed the validation study. The study was conducted in accordance with ISO 16140-6:2019 and reference methods ISO 6579-1:2017 and ISO 6579-1:2017/Amd 1:2020. The scope of validation covers the confirmation of presumptive Salmonella spp. colonies isolated from selective and non-selective agars under specified conditions, supporting a genus-level claim.

This validation confirms that the Autof ms1000 method provides a reliable alternative for the confirmation of Salmonella spp. in food chain testing, strengthening confidence in microbiological safety and quality assurance.

The certificate and detailed summary report of this study (2023LR116) are available on our website, under “ISO 16140-6 (Confirmation and serotyping methods)”.

New certificate for Neogen’ Petrifilm® Bacillus cereus (BC) Count Plate Method

MicroVal is pleased to announce the validation of the Petrifilm® Bacillus cereus (BC) Count Plate Method from Neogen Corporation. The validation was carried out by Q Laboratories.

The study was conducted in accordance with ISO 16140-2:2016 and ISO 16140-2:2016/Amd 1:2024. The reference method used was ISO 7932:2004 – Microbiology of food and animal feeding stuffs – Horizontal method for the enumeration of presumptive Bacillus cereus – Colony count technique at 30 °C.

Scope of validation is a broad range of foods and animal feed, including: Pasteurized milk & dairy products; Dried cereals, fruits, nuts, seeds, and grain products; Multi-component foods; Ready-to-eat and ready-to-reheat meat and poultry; Infant formula and infant cereals; Animal food & feed. The sample size is 50 g for all categories.

This validation confirms that the Petrifilm® BC Count Plate Method provides a reliable alternative to the reference method for the enumeration of Bacillus cereus in diverse food and feed matrices.

The certificate and detailed summary report of this study (2024LR132) are available on our website.

We’ve hit 1,000 followers!

MicroVal now has more than 1000 people following our page on LinkedIn! A big thank you to each and every one of you for joining us. We’re thrilled to see so much interest in method validation and certification and in how MicroVal contributes to advancing this field.

So far, we’ve used this space to share updates on new certificates and upcoming conferences. But we’d love to hear from you. What kind of content would you like to see more of?

Drop your thoughts in the comments of our LinkedIn page.

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!