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Rapid Pathogen Detection using Phage Technology

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Rapid Pathogen Detection using Phage Technology

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    3. Microbiological risk (1/2)

    4. Microbiological risk (2/2)

    5. Pathogens incidence worldwide 2 billion of illnesses 1.8 million of deaths.

    6. Pathogens incidence USA 76 millions of foodborne illnesses, 300 000 hospitalizations, 5 000 deaths, 1 200 outbreaks.

    7. Pathogens incidence USA (2006)

    8. Pathogens incidence Europe (2007)

    10. Due Diligence

    11. International regulation

    12. FDA Guidance document

    13. International regulation

    14. Salmonella 1/2

    15. Salmonella 2/2

    16. Listeria monocytogenes

    17. Conventional Methods 1/3

    18. Conventional Methods 2/3

    19. Conventional Methods 3/3

    20. Large volume of product produced Lack of space in warehouse Short shelf-life Fast sorting of raw material Reliability and reproducibility of results

    21. Room for Alternative Methods

    22. USDA-FSIS MLG

    23. Mains steps for Pathogen detection

    24. Conventionnal Methods vs Rapid Methods

    25. Alternative Methods 1/2

    26. Alternative Methods 2/2

    28. How to choose?

    29. Complete validated solution

    31. Two Phases Validation Pre-Collaborative Study Inclusivity and Exclusivity Method Comparison 20 foods USDA or FDA reference methods Collaborative Study Method Comparison 20 foods USDA or FDA reference methods Quantitative method: 8 laboratories minimum Qualitative method: 10 laboratories minimum

    32. Adopted as First Action Successful Collaborative Study In accordance with AOAC specifications Recommended by General Referee Approved by Methods Committee Published in Journal of AOAC Compiled in OMA Order of steps to be followed for method adoption.Order of steps to be followed for method adoption.

    33. OMA Approval Process - Overview

    34. Monitored by the Research Institute PTM-Approval has gained wide acceptance in the US, Europe, and globally. Third Party validation Independent single Lab Validation Certification Mark Annual Review Differs from PVM 1. Independent evaluation done 2. Proprietary methods 3. Package insert is reviewed 4. Lab must have a QA system in place 5. Method reviewed annually Data submission - data supporting claims of product Independent testing lab - verify performance of kit, evaluation package insert, GR and reviewers go over data and make final decision Certification mark - recognized my variety of organizations Reviews - verify no changes have been made Differs from PVM 1. Independent evaluation done 2. Proprietary methods 3. Package insert is reviewed 4. Lab must have a QA system in place 5. Method reviewed annually Data submission - data supporting claims of product Independent testing lab - verify performance of kit, evaluation package insert, GR and reviewers go over data and make final decision Certification mark - recognized my variety of organizations Reviews - verify no changes have been made

    35. Two-part Validation Internal Studies and Independent Study One Independent Laboratory required contracted by AOAC RI Use AOAC, FDA, USDA, ISO, AFNOR or other official reference methods Data review by two Expert Reviewers and General Referee Validation Time: can be less than 6 months

    36. Internal Study Inclusivity Exclusivity Method Comparison 10 foods for Variety of Foods choice of reference methods Ruggedness Stability Lot-to-Lot Variation Independent Study Method Comparison 1 laboratory 1-2 foods

    37. List of PTMSM Approved Methods

    42. It depends on the organism tested: Salmonella EN ISO 6579: Microbiology of food and animal feeding stuffs Horizontal Method for the detection of Salmonella spp. Listeria monocytogenes EN ISO 11290-1: Microbiology of food and animal feeding stuffs Horizontal Method for the detection of Listeria monocytogenes EN ISO 11290-2: Microbiology of food and animal feeding stuffs Horizontal Method for the enumeration of Listeria monocytogenes E. coli O157 ISO 16654:2001: Microbiology of food and animal feeding stuffs Horizontal Method for the detection of Escherichia coli O157

    43. Preliminary Study Inclusivity and Exclusivity LOD50 (Relative detection limit) Method Comparison Ease of Use Collaborative Study Method Comparison 1 food, 8 replicates 1 strain at 3 levels 10 laboratories minimum

    46. All key performance criteria are specified Renewed every 4 years Available on the AFNOR website

    47. All key detailled performance criteria are specified Renewed once there is a change in the protocol Available on the AFNOR website

    48. USA regulation Meat, Poultry, Eggs = USDA Traditional Methods = MLG Rapid Methods = AOAC RI or OMA (comparing with MLG) Others = FDA Traditional Methods = BAM Rapid Methods = AOAC RI or OMA (comparing with BAM) Ease of Use EU regulation Food Micro criteria = 2073/2005 Traditional Methods = ISO Methods Rapid Methods = ISO 16140

    50. Cette slide est trs importante car elle rsume les principales innovations de ces seize dernires annes. Toutes ces innovations sont lies lvolution de vos besoins en terme de rapidit, praticabilit, performance et du workflow. Cette slide est trs importante car elle rsume les principales innovations de ces seize dernires annes. Toutes ces innovations sont lies lvolution de vos besoins en terme de rapidit, praticabilit, performance et du workflow.

    51. VIDAS Principle

    52. Portfolio

    53. Cette slide est trs importante car elle rsume les principales innovations de ces seize dernires annes. Toutes ces innovations sont lies lvolution de vos besoins en terme de rapidit, praticabilit, performance et du workflow. Cette slide est trs importante car elle rsume les principales innovations de ces seize dernires annes. Toutes ces innovations sont lies lvolution de vos besoins en terme de rapidit, praticabilit, performance et du workflow.

    54. Cette slide est trs importante car elle rsume les principales innovations de ces seize dernires annes. Toutes ces innovations sont lies lvolution de vos besoins en terme de rapidit, praticabilit, performance et du workflow. Cette slide est trs importante car elle rsume les principales innovations de ces seize dernires annes. Toutes ces innovations sont lies lvolution de vos besoins en terme de rapidit, praticabilit, performance et du workflow.

    55. Cette slide est trs importante car elle rsume les principales innovations de ces seize dernires annes. Toutes ces innovations sont lies lvolution de vos besoins en terme de rapidit, praticabilit, performance et du workflow. Cette slide est trs importante car elle rsume les principales innovations de ces seize dernires annes. Toutes ces innovations sont lies lvolution de vos besoins en terme de rapidit, praticabilit, performance et du workflow.

    56. Cette slide est trs importante car elle rsume les principales innovations de ces seize dernires annes. Toutes ces innovations sont lies lvolution de vos besoins en terme de rapidit, praticabilit, performance et du workflow. Cette slide est trs importante car elle rsume les principales innovations de ces seize dernires annes. Toutes ces innovations sont lies lvolution de vos besoins en terme de rapidit, praticabilit, performance et du workflow.

    59. A simple and rapid protocol

    60. Internationally recognized and validated ISO 16140/AFNOR Certification in May 2009 for raw ground beef. ISO 16140/AFNOR Certification in December 2009 for all food and environmental samples AOAC RI validated in July 2009 for raw ground beef, beef trim, produce and irrigation water.

    62. Cette slide est trs importante car elle rsume les principales innovations de ces seize dernires annes. Toutes ces innovations sont lies lvolution de vos besoins en terme de rapidit, praticabilit, performance et du workflow. Cette slide est trs importante car elle rsume les principales innovations de ces seize dernires annes. Toutes ces innovations sont lies lvolution de vos besoins en terme de rapidit, praticabilit, performance et du workflow.

    63. VIDAS SLMX protocol Validated according to ISO 16 140 on raw beef & veal and pasteurized egg products. (BIO 12/26-07/09)

    64. VIDAS SLMX is certified by AFNOR Validation according to the ISO 16 140 norm on raw beef & veal and pasteurized egg products. (BIO 12/26-07/09) Results from ISO 16 140 preliminary study VIDAS SLMX performances

    65. VIDAS Listeria monocytogenes Xpress Validated according to ISO 16 140 on human food and production environmental samples. (BIO 12/27-02/10)

    66. VIDAS LMX PRINCIPLE

    68. VIDAS UP Salmonella VIDAS UP Listeria

    72. 1 seule matrice lait . Mme souche qui croisait ? pdt a t retravaill depuis 1 seule matrice lait . Mme souche qui croisait ? pdt a t retravaill depuis

    76. TAKE AVWAY

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