Updated joint MicroVal / AOAC RI validation studies
Recently the testkit Greenlight(tm) Model 960 from Luxcel Biosciences Ltd. has been evaluated:
- For AOAC RI: this test kit is approved as Performance Tested MethodsSM.
- For MicroVal: only the Method Comparison study has successfully been completed.
For more details, see the AOAC/MicroVal.
15th MicroVal certificate granted!
Recently four new MicroVal certificates have been granted. The following validations according to EN ISO 16140 have been approved by MicroVal:
- foodproof® Enterobacteriaceae plus E. sakazakii (Cronobacter spp.) Detection Kit, Hybridization Probes (Kit R310 15 for LightCycler 2,0 and 480) for detection of Enterobacteriaceae (MicroVal certificate LR08) and Cronobacter spp (MicroVal certificate LR09)
- foodproof® Enterobacteriaceae plus E. sakazakii (Cronobacter spp.) Detection Kit, (Kit R 302 15, 5'Nuclease )for detection of Enterboacteriaceae (MicroVal certificate LR19) and Cronobacter spp (MicroVal certificate LR20)
The validated methods are real-time PCR-based systems for the qualitative detection of Enterobacteriaceae DNA including the simultaneous identification of Cronobacter spp. (Enterobacter sakazakii)
The validation has been carried out by the MicroVal Expert laboratory RIKILT, NL. The MicroVal Certification Body is Lloyd's Register QA (NL) and the method reviewers were ir. Henk Stegeman (NL) and Prof. Basil Jarvis (UK). The certificates can be downloaded at validated methods.
Rules updated
The MicroVal Rules and Certification Scheme is recently modified and published. The new version is version 6, June 2010. In this new version an update has been made to amongst others the new flowchart certification process, update requirements Expert labs, Time table for MV validation and certification, certificate of compliance (now 2 parts for quantiative and qualitative methods).
The latest updates to the MicroVal Rules and Certification Scheme have been made available. They can be found under Rules & Standards or downloaded directly, here.
New MicroVal Certificate
BioControl Systems, Inc SimPlate Yeast & Mold Color Indicator method
SimPlate Yeast and Mold Color Indicator (Y&M-CI) method is used for the detection and quantification of yeast and mold in foods. It is based on Binary Detection Technology (BDT) which equates the presence of yeast and mold to the presence of a colour change in the medium.
The SimPlate Y&M-CI was already granted the AOAC Official Method. Therefore MicroVal decided for this testkit to become MicroVal approved by only performing the Method comparison study method according to the MV Rules and Certification Scheme, version 5. The results of the AOAC interlab study (reference method ISO 21527-1) are considered as comparable to the interlaboratory study that has to be performed by EN ISO 16140.
The validation has been carried out by the MicroVal Expert laboratory ADRIA Developpement, France. The MicroVal Certification Body is Lloyd's Register QA (NL) and the method reviewers were ir. Henk Stegeman (NL) and Prof. Basil Jarvis (UK).
The certificate can be downloaded.
10th MicroVal certificate granted!
bioMérieux CampyFood agar method for Campylobacter spp. enumeration.
CampyFood is a ready-to-use culture medium, CampyFood Broth (CFB) for the detection and enumeration of Campylobacter spp. Two broths can be used for the primary sample dilutions: the CampyFood broth and peptone water.
The validation has been carried out by the MicroVal Expert laboratory ADRIA Developpement, France. The MicroVal Certification Body is Lloyd's Register QA (NL) and the method reviewers were ir. Henk Stegeman (NL) and Prof. Basil Jarvis (UK).
The certificate can be downloaded.
BioControl Systems, Inc SimPlate Total Plate Count Color Indicator.
SimPlate Total Plate Count Color Indicator (TPC-CI) method is used for the detection and quantification of total aerobic micro-organism populations. It is based on binary detection technology (BDT) which equates the presence of total aerobic micro-organisms to the presence of a colour change in the medium.
The SimPlate TPC was already granted the AOAC Official Method. Therefore MicroVal decided for this testkit to become MicroVal approved by only performing the MC study method according to the MV Rules and Certification Scheme, version 5. The results of the AOAC interlab study (reference method ISO 4833) are considered as comparable to the interlaboratory study that has to be performed by ISO 16140.
The validation has been carried out by the MicroVal Expert laboratory ADRIA Developpement, France. The MicroVal Certification Body is Lloyd's Register QA (NL) and the method reviewers were ir. Henk Stegeman (NL) and Prof. Basil Jarvis (UK).
The certificate can be downloaded.
New MicroVal Certificate
Last week a new MicroVal certificate was granted for the validation of Oxoid Brilliance(TM) Staph 24 Agar. Oxoid Brilliance Staph 24 Agar is a new medium for the enumeration of coagulase positive staphylococci from foods within 24 hours incubation at 37C. The chromogenic medium is designed as an improved alternative to Baird Parker Egg Yolk Tellurite medium as referred to in ISO 6888-1 for the enumeration of coagulase positive staphylococci.
The validation has been carried out by the MicroVal Expert laboratory LFMFP-UGent, Belgium. The MicroVal Certification Body is Lloyd's Register QA (NL) and the method reviewers were ir. Henk Stegeman (NL) and Dr. Jo Klaessens (NL).
The certificate can be downloaded.
New MicroVal Certificate
This week a new MicroVal certificate was granted. The certificate for the RIDASCREEN® Salmonella of R-Biopharm AG has been issued based upon Annex A of EN ISO 16140, Specific rules for the acceptance of external results already obtained in a prior validation scheme. The certificate is based upon a study performed by by Institut Scientifique d'Hygiène & d'Analyse (ISHA) in 2008. The MicroVal Certification Body was Lloyd's Register QA (UK / NL) and the method reviewers were Prof. Basil Jarvis (UK) and ir. Henk Stegeman (NL). The certificate can be downloaded.
Combined validation MicroVal / AOAC
This year the first combined validation studies for MicroVal are being developed.The first result is expected at the MicroVal symposium. During this symposium Chris Baylis, Campden BRI, a MicroVal Expert Laboratory, will give a presentation about the status and experience with the combined validation AOAC/MicroVal and MicroVal/NordVal. For more information see Combined validations. Furthermore Scott Coates, managing director AOAC RI and Sven Qvist, chairman of NordVal will give an update on the harmonized cooperative validations.
MicroVal 2nd International Symposium
Updates to our symposium website include:
- A more detailed program
- Extra details for exhibitors
Registration has already started and can be done by filling in the registration form. If you intend to book a stand please contact the secretariat for your booth preference as several have already been booked (see exhibitors)
New MicroVal Certificate!
Last week a new MicroVal certificate was granted. The validation of Nestec Laboratory Instruction LI-00.713-5 for the detection of Salmonella has been carried out by RIKILT Institute of Food Safety, Wageningen UR. This is a routine method for the detection of Salmonella in raw materials, environmental, line and finished product samples. It is based on ISO 6579:2002 but contains some major simplifications and modifications.
The MicroVal Certification Body was Lloyd's Register QA (NL) and the method reviewers were Prof. Basil Jarvis (UK) and ir. Henk Stegeman (NL).
The certificate can be downloaded.
Registration MicroVal Symposium started
Registration for the MicroVal Symposium 2009 has started. Visit the Symposium website for details.
2nd MicroVal symposium
MicroVal is organising its 2nd symposium. This MicroVal
symposium will be held on Thursday 12 November 2009
in Amsterdam.
Please keep this date in your dairy, more details will follow soon. If you
need more information please contact the MicroVal secretariat: tel. +31 15
2690 112 or extension 369.
4 New MicroVal Certificates!
Last year the first MicroVal certificate has been granted. Today we can announce that recently four new MicroVal certificates have been granted. The following validations according to EN ISO 16140 have been approved by MicroVal:
- Compact Dry ETB for enumeration of Enterobacteriaceae
- Compact Dry CF for enumeration of Coliforms
- Compact Dry EC for enumeration of Coliforms
- Compact Dry EC for enumeration of E.coli
Details:
- Supplier for these test kits is Hyserve GmbH & Co
- Manufacturer: Nissui Pharmaceutical Co. Ltd
- MicroVal Expert Laboratory: CCFRA (UK)
- MicroVal Certification Body: Lloyd's Register QA (NL)
- MicroVal method reviewers: Prof. Basil Jarvis (UK) and Henk Stegeman (NL)
Status of other MicroVal Validations
The next 6 MicroVal validations are being performed; 3 validations are in progress with the MicroVal Expert Laboratory CCFRA (UK) and 3 by MicroVal Expert Laboratory RIKILT, Institute of Food Safety (WUR) (NL). Two contracts are nearly closing and we are in discussion with several other manufacturers.
Report Validation Studies
The validation reports can be downloaded see Validated methods.
Belgium Approval of MicroVal Certificate
The supplier of the Compact Dry TC, the first MicroVal certificate, has been forwarded to the Belgium authorities for approval. By the end of 2007 the MicroVal approved testkit was approved and added to the list of approved FAVV methods.
Information and Application form
If you need more information you can contact the MicroVal secretariat (microval@nen.nl) or in case of a MicroVal application please download the MicroVal application form.
FOODMICRO 2008
Beginning of September 2008 the 21st International ICFMH Symposium 'Evoling Microbial Food Quality and Safety' will be held in Aberdeen. NordVal is chairing a parallel session 'Validation of alternative methods – why and how'. The purpose is to give an update of the present situation on validation, legislation, etc. in Europe. The session will be held 2 September 2008.
NordVal invited the MicroVal secretariat to give a presentation about the status of MicroVal.
Furthermore MicroVal will also be represented with an exhibition stand which is shared by the MicroVal Certification Body, Lloyd's QA, the MicroVal Expert Laboratories CCFRA and RIKILT, Institute of Food Safety (WUR) and the MicroVal Secretariat (NEN).
Observations from the MicroVal Symposium
On March the 20th 2007 a MicroVal symposium was held in Amsterdam. At this symposium the first MicroVal certificate was presented by Chairman Peter McClure to Stephen Speidel (HyServe GmbH. & Co.) for the Compact Dry TC method. At this milestone the opportunity was taken to reflect on recent experiences, suggest improvements and discuss a wide variety of issues surrounding the validation of rapid methods. The symposium was attended by representatives from all areas of the food sector. Users, manufacturers, certification bodies and legislators provided a background with plenty of feedback.
The focus of the presentations and subsequent discussions was the EN/ISO 16140 standard (Protocol for the validation of alternative methods). This standard establishes the general principle and the technical protocol for the validation of alternative methods in the field of microbiological analysis of food, animal feeding stuff and environmental and veterinary samples. Its use is required by the EU.
Experience with the first certificate
An overview of 16140 from a technical perspective was provided first by Lloyds Register QA, the procedural aspects were discussed. This was followed by a presentation Campden & Chorleywood (CCFRA) in which the intricacies of the statistical data analysis were discussed as well as the obstacles encountered.
Point of view users
Nestlé presented issues encountered by users when selecting rapid methods. Nestlé's structure for evaluating traditional and alternative methods (NesVal) were outlined and the requirements it places on testkits as users. 3M Deutschland discussed their selection procedures and echoed the concerns of Nestlé regarding the variety and lack of clarity companies have when selecting rapid methods.
Regulatory perspectives
The regulatory view was provided by the EC DG SANCO (EC Regulation 2073/2005), the Belgian Federal Food Safety (national perspective), FLEP Denmark (MicroVal position) and the UK Health Protection Agency (national perspective).
Hereafter the current status and future changes of EN/ISO 16140 were presented. It is expected that at least 2- 3 years will be needed before all parts of the revised standard will be available for comments by ISO and CEN. The final presentations concerned the state of the global harmonization efforts, by AOAC International. This presentation focused on the harmonization of international validation for analytical methods, followed by AOAC Research Institute that detailed the ongoing harmonization efforts between MicroVal and AOAC.
After the presentations, there followed a lively debate concerning the road ahead. The diversity of the participants was again obvious, as theoretical questions would quickly be illustrated with real-world examples. The general feeling was that it had been a productive day for all concerned. (For more information download the summary of the symposium).
Press Release MicroVal
First MicroVal Certificate granted
At the MicroVal symposium on 20 March 2007 the first MicroVal certificate was granted for the COMPACT DRY TC, supplied by HYSERVE GmbH & Co, Germany and manufactured by Nissui Pharmaceutical Co.Ltd. in Japan.
The MicroVal Certification Body responsible for the certification process was Lloyd's Register Quality Assurance (LRQA), The Netherlands. The validation process according to the EN ISO 16140 was performed by the MicroVal Expert Laboratory Campden & Chorleywood Food Research Association (CCFRA), UK
Five more certification and validations are underway and scheduled for later this year.
MicroVal's organisation of validation and certification is based on an independent European structure.
MicroVal offers:
- an open platform for all European Certification Bodies
- aiming at a harmonized interpretation of the EN ISO 16140
- working towards a harmonized international market for all test kits
- is headed by one European platform with all European stakeholders involved
- a neutral MicroVal secretariat not part of a certification organisation
For more information, contact the MicroVal secretariat. Tel. +31 15 2690 112, http://www.microval.org and email microval@nen.nl.
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