In September 2022, MicroVal has approved the issuing of the certificate for MCS Diagnostics’ CertaBlue TVC for the detection of Total Viable Count. WFC has carried out the validation study of this rapid method, based on ISO 16140-2:2016, for the scope of broad range of foods and environmental samples. To obtain the broad range of foods claim, the following categories were included in the validation study:
The CertaBlue TVC test is designed to rapidly detect microbial contaminations. An inoculated vial is placed into the AutoScanner System, where it is incubated and monitored in real time. If growth is detected, the sample fails; if there is no detection, the sample passes (i.e., the counts are below the specification limit).
In the validation study, the CertaBlue TVC has been compared to the ISO 4833-1:2013. Although the reference method is generally used to enumerate the level of microorganisms, in this validation it was used to establish if levels of microorganisms exceed the defined threshold of 1 cfu per g for liquid products, 1 cfu per swab for swabs and 10 cfu per g for other products. Thus, a qualitative presence/absence approach with a set presence/absence limit was used, where presence of a single colony (solid and semi-solid products always require a 1:10 dilution step) was equivalent to a “detected” result and absence of a single colony was equivalent to a “not detected” result.
The certificate and the accompanying summary report, number 2021LR94, can be found on the website under ‘issued certificates / alternative methods’.
August 30th 2024 - MicroVal (NEN) is happy to welcome three new members of the MicroVal Technical Committee (MVTC). They are Eva van Hees (TLR International Laboratories), Guodong Zhang (FDA), and Kirsten van Kooten (Eurofins WFC). With them, MicroVal has 28 members for this technical committee. The #MVTC governs the validation process towards #certification and conducts #...
August 28th 2024 - MicroVal has approved issuing three certificates for One Plate by Neogen Cooperation. Campden BRI has carried out these validation studies of this alternative method based on ISO 16140-2:2016. The first certificate is One Plate Yeast & Mould. The validation is for the enumeration of yeasts and moulds. This One Plate has been validated against ISO 215...
August 26th 2024 - We are excited to announce that MicroVal will be hosting a session at the AOAC INTERNATIONAL 2024 Annual Meeting & Exposition in Baltimore, USA. Curious about what MicroVal is and how we operate? Join us on Monday, August 26, 2024, from 17:30 to 18:30 in the Essex meeting room for an in-depth look at MicroVal. During this session, members of the Micr...
July 3rd 2024 - MicroVal is happy to welcome two new members of the MicroVal General Committee (MGC). Yannick Bichot (Bio-Rad Laboratories) and Frédéric Martinez (Neogen Corporation). With them, there are currently 16 members in the MGC. The MGC is responsible for setting up standardized procedures, complementary to ISO 16140-2 and ISO 16140-6, for conducting the vali...
June 25th 2024 - In May 2024, MicroVal approved the issuing of a certificate for Compact Dry CFR, manufactured by Shimadzu Diagnostics Corporation. Compact Dry CFR features ready-to-use dry media sheets comprising a culture medium and a cold-soluble gelling agent, rehydrated by inoculating 1 ml diluted sample into the center of the self-diffusible medium. This chromogenic...
June 13th 2023 - In June 2023, MicroVal has approved the issuing of the certificate for MCS Diagnostics’ CertaBlue YM test for the detection of Yeast and Mold. WFC Analytics has carried out the validation study of this rapid method, based on ISO 16140-2:2016, for the scope of broad range of foods (except cooked poultry products). The CertaBlue YM test is designed to ra...
May 30th 2023 - MicroVal has approved the issuing of the certificate for ThermoFisher Scientific’s SureTect Salmonella Species PCR Assay. Q Laboratories carried out the extension validation study for a broad range of foods in which the use of pre-warmed (41.5 or 37 ± 1 °C) BPW ISO as the primary enrichment media was evaluated, in addition to alternative sample sizes. ...
May 12th 2023 - MicroVal has approved the issuing of the extended certificate for Millipore Sigma's Assurance GDS for Cronobacter Tq II. Campden BRI carried out the extension study for a new confirmation method in combination with two different isolation methods. The Assurance GDS for Cronobacter Tq II method was previously validated in December 2018 for infant formula and...
February 21st 2023 - MicroVal has approved the issuing of the certificates for Bentley's BactoCount IBC 3.0 and BactoCount IBCm 3.0. ACTALIA Cecalait carried out the validation study for the enumeration of somatic cells and total bacterial count for the scope of raw cow's milk. The BactoCount IBC 3.0 and BactoCount IBCm 3.0 are fully automatic instruments that implement flow...
February 2nd 2023 - MicroVal is an international organisation for the validation of alternative methods in food and water microbiology. The basis for these validation studies is the ISO 16140 series. The first MicroVal certificate dates back from 2007. Since then, more than 70 test kits and methods by manufactures in North America, Asia and Europe, have been successfully valid...
January 24th 2023 - MicroVal has approved the issuing of the certificate for Check-Points's Check&Trace Salmonella 2.0. WFC Analytics carried out the validation study, based on ISO 16140-6, for an alternative method for the confirmation and typing of Salmonella spp. Following from the validation study, the Check&Trace Salmonella 2.0 (CTS 2.0) is considered equivalent t...
January 17th 2023 - In December 2022, MicroVal has approved the issuing of the renewed certificate for Bio-Rad's iQ Check STEC VirX, based on the extension validation study to include food products based flours and raw doughs within the scope. Like the initial validation study, also the extension study was carried out by ADRIA Développement. The iQ-Check STEC VirX fo...
October 6th 2022 - In September 2022, MicroVal has approved the issuing of the certificate for MCS Diagnostics' CertaBlue TVC for the detection of Total Viable Count. WFC has carried out the validation study of this rapid method, based on ISO 16140-2:2016, for the scope of broad range of foods and environmental samples. To obtain the broad range of foods claim, the following ...
September 26th 2022 - MicroVal has recently issued the certificate for Neogen's Soleris Commercial Sterility Testing Vials (NF-105) for the determination of commercial sterility in UHT treated milk and dairy alternative plant drinks. These are ready-to-use media vials containing a broth able to grow aerobic, mesophilic microorganisms (bacteria, yeasts and moulds) that are able t...
July 15th 2022 - In June 2022, MicroVal has approved the issuing of the certificate for Bio-Rad's iQ-Check™ STEC VirX kit for real-time PCR detection of virulence genes in Shiga toxin-producing Escherichia coli. ADRIA Développement has carried out the validation study of this alternative method, based on ISO 16140-2:2016, for the scope of raw meat products (excluding pou...
May 24th 2022 - MicroVal has approved the issuing of the certificate for Compact Dry LM by Nissui. This is a chromogenic medium for the detection and enumeration of Listeria Monocytogenes. Campden BRI has carried out the validation study of this alternative method, based on ISO 16140-2:2016, for the scope broad range of foods, consisting of the following categories, plus e...
May 4th 2022 - MicroVal has approved the issuing of the certificate for BIOTECON diagnostics GmbH's foodproof Enterobacteriaceae plus Salmonella Detection LyoKit - 5’Nuclease. The validation study is carried out ADRIA Développement and is based on ISO 16140-2:2016. The foodproof Enterobacteriaceae plus Salmonella Detection LyoKit - 5’Nuclease is a PCR kit for the ...
September 1st 2021 - MicroVal has approved the issuing of the certificate for Kylt Salmonella spp. 2.0 by AniCon Labor GmbH. Campden BRI has carried out the validation study of this alternative method, based on ISO 16140-2:2016, for the detection of Salmonella spp in 4 different categories: Raw meat and ready to cook meat products, Raw poultry and ready to cook poultry prod...
July 21st 2021 - MicroVal has approved the issuing of the certificate for Neogen's One Plate Listeria (OP-L). Campden BRI has carried out the validation study of this alternative method, based on ISO 16140-2:2016, for the enumeration of two different targets, Listeria monocytogenes and Listeria spp., against the reference method ISO 11290- 2:2017. The method, One Plate List...
July 13th 2021 - In June 2021, MicroVal has approved the issuing of the certificate for the Thermo Scientific Oxoid Cronobacter Precis method. The validation was conducted by Laboratoire Microsept. Besides the ISO 16140-2 validation study, Laboratoire Microsept also interpreted part of the results obtained during the ISO 16140-2 validation study of the ThermoScientific Su...
April 9th 2021 - 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 ...
February 8th 2021 - 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 Validat...
December 7th 2020 - 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 extens...
November 10th 2020 - 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 Dével...
July 2nd 2020 - 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 ...
June 25th 2020 - 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...
April 9th 2020 - 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, n...
March 9th 2020 - 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 valida...
February 18th 2020 - 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, whic...
February 13th 2020 - 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 Salmone...
February 7th 2020 - 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 sp...
January 16th 2020 - 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...
January 10th 2020 - 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,...
November 4th 2019 - 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 vali...
November 1st 2019 - 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 ...
October 15th 2019 - 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 f...
October 1st 2019 - 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 Ent...
September 23rd 2019 - 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 v...
March 15th 2019 - MicroVal has approved the issuing of the certificate for a method by Biocontrol Systems, Inc. The Assurance GDS® Cronobacter Tq II for the detection of Cronobacter spp. in infant formula, infant cereals and environmental samples has been certified, based on the results of the validation study performed by Q laboratories. The certificate has number 2017LR77....
February 15th 2019 - MicroVal has approved the issuing of the certificate for a method by 3MTM Food Safety. The Petrifilm™ Rapid E. Coli Coliform Count (REC) for the enumeration of E. coli and coliforms in a broad range of foods has been certified, based on the results of the validation study performed by Q laboratories. The certificate has number 2017LR76....
January 15th 2019 - MicroVal has approved the issuing of the certificate for the method by Charm Sciences, Inc. The Peelplate® EB for the detection and enumeration of Enterobacteriaceae in heat processed milk and dairy products, infant formula and infant cereal, has been certified based on the results of the validation study by Q laboratories. The certificate can be found by ...
January 5th 2019 - In December 2018 MicroVal approved the issuing of two certificates for two MC-Media pad methods developed by JNC Corporation. The MC-Media pad CCTM for the enumeration of coliforms in foods and the MC-Media pad ECTM for the enumeration of coliforms and Escherichia coli in foods were both certified based on the results of a validation study by Campden BRI. Th...
December 17th 2018 - Two SY-LAB certificates issued In December MicroVal approved the issuing of two certificates for methods developed by SY-LAB Geräte GmbH. The RiboFlow® Listeria Twin Testkit for the detection of Listeria Monocytogenes and Listeria spp was certified based on the results of a validation study by RIVM. Campden BRI performed the validation study for AMP-600...
October 30th 2018 - On 29 October 2018, MicroVal organised a successful workshop on the validation and verification of alternative microbiological confirmation methods. Recently MicroVal approved on the issuing of the first validation certificates for confirmation methods worldwide, for the Bruker Maldi-Tof. These have been issued based on the results of four parallel validati...
October 1st 2018 - An important part of the MicroVal validation process is the presentation and discussion of study results in the MicroVal Technical Committee (MVTC). The MVTC comprises of more than 15 members, including representatives of test kit manufactures, expert labs, end users and government. Decisions in the MVTC regarding, for instance, validation are based on c...
September 15th 2018 - MicroVal is the first validation platform to approve the issue of certificates according to ISO 16140-6 for confirmation methods. The Maldi Biotyper has been approved according to the new ISO 16140-part 6 standard. Four certificates have been issued, based on the results of parallel validation studies for four different target organisms (Cronobacter spp, Sa...