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.

News archive

New Certificate for CertaBlue YM

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...

New Certificate for SureTect Salmonella Species PCR Assay

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. ...

Extended Certificate for Assurance GDS for Cronobacter Tq II

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...

New Certificate for BactoCount IBC 3.0 and IBCm 3.0

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...

Call for experts: milk analysis

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...

New ISO 16140-6 validation for Check&Trace Salmonella 2.0

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...

Renewed certificate for iQ-Check STEC VirX

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...

First MicroVal certificate for MCS Diagnostics’ CertaBlue detection method

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 ...

First MicroVal certificate for commercial sterility detection method

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...

New Certificate for iQ-Check™ STEC VirX

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...

Twelfth certificate for Nissui’s Compact Dry

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...

New certificate for foodproof Enterobacteriaceae plus Salmonella Detection LyoKit – 5’Nuclease

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 ...

New certificate for Kylt Salmonella spp. 2.0

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...

New certificate issued for Neogen’s One Plate Listeria

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...

New Certificate for Thermo Scientific Oxoid Cronobacter Precis

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...

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

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 ...

MicroVal Expert opinion about AOAC Validation Coronavirus Test Kits

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...

Renewed and extended certificate for Assurance GDS E. coli 0157:H7 Tq

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...

Certificate GENE-UP EHEC extended

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...

Renewed and extended certificate for GDS Salmonella Tq

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 ...

Certificate issued for OBOP-Salmonella

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...

New certificate for CompactDry BC

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...

Postponement MicroVal workshop

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...

MicroVal workshop on new developments and future needs of validation methods

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...

Certificate MALDI Biotyper Salmonella spp. extended with addition CASE agar

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...

vetproof® Salmonella Detection Kit included in MicroVal certificate

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...

MicroVal Issues First Certificate for STEC Detection Method

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...

Certificate FOSS BactoScan FC/FC+ renewed

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,...

MicroVal welcomes two new expert labs

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...

Foodproof® Salmonella spp. method renewed and extended for lyophilized kit

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 ...

Compact Dry TC certificate renewed

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...

First Semi-Quantitative Certification for Neogen’s Soleris System for Detection of Enterobacteriaceae in Dairy Products

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...

MicroVal’s first certificate within scope of water

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...

New BioControl Assurance GDS certificate issued

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....

First MicroVal certificate for method by 3M Food Safety

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....

First MicroVal certificate issued for Charm Sciences’ method

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 ...

Two new MC-Media Pad certificates issued

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...

Two SY-LAB certificates issued

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...

Successful workshop confirmation methods

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...

MicroVal: validation based on consensus, standards and rules

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...

World premiere: MicroVal validates four confirmation methods

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...

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