SPT - bioMerieux

VIDAS UltimatePerformance (Phage)SPTStan BaileyDirector, Scientific AffairsbioMerieux Industry

VIDAS is a PROVEN…Largest Installed Base 26,000 VIDAS worldwide 3,500 VIDAS Industry3

…..& EVOLVING TECHNOLOGYContinuous improvement in cost effectivenesssimplified workflow, reduce TTR, connectivity, RTU mediaELFAImmunoConcentrationFab FragmentRecombinant phage protein1992 1993 19962002 2003 2004 20062007200820092011ListeriaECOICS+ SLMLMO2SET2LSXNextDayLDUO VIDAS ECPTHeat & GoSLMXLMXSPTLPT4

VIDAS Assay OverviewInnovative Test Format:Strip & Solid PhaseReceptacle (SPR)Ready-to-use reagentsin 10-well stripSpecific antibody orphage coated onto SPR5

Recombinant Phage Protein Technology“Capture”Molecules and“Lytic” EnzymesBuilding blocks ofthe Profostechnology

Selection of theE.coli O157 H7phageDetermination ofthe compositionand structure ofthe proteinCloning, Production ofthe recombinantprotein“Capture”MoleculesCoating of the phageprotein onto thesurface of the SPRVIDAS UP E.coli O157:H7Phage protein

VIDAS® IMMUNO ASSAYCAPTURE OFANTIGENSSANDWICH TESTDETECTION370 nm 450 nmThe phage protein (orantibody) capturesthe target pathogensA second antibody orphage protein conjugatedwith an enzyme bindsto the captured targetThe intensity of thereaction is interpretedby the system

Evolving with VIDAS UPSalmonella (SPT)9

…..& EVOLVING (Salmonella)Continuous improvement in cost effectivenesssimplified workflow, reduce TTR, connectivity, RTU mediaImmunoConcentrationRecombinant phageprotein199319962005200720092011SLMICS+ SLMEasy SLMVIDASHeat & GoSLMXSPT10

VIDAS UP SalmonellaExtremely simplified protocolFood & Envt.225 ml of BPW +1ml supplement (green)375g NFDM, Pet Food, Chocolate, Produce,Ground Beef, Ground Turkey, Almonds1,125 ml of BPW +5ml supplement (green)41.5 +/- 1°C18-24 hHeat & Go 5 min**Except for poultry & egg products41.5 +/- 1 °C - 22-26 hHeat & Go 5 min*VIDAS UP Salmonella48 minVIDAS UP Salmonella48 min11

Rapidity, Simplicity & FlexibilityNeeds Benefits Product FeaturesRapid results Increased reactivity (logistics, rawmaterial orientation…) Decreased storage cost- 18 – 24 h enrichment- 48 min VIDAS runProductivitySimple &Flexibleprotocol Labor cost savings Limited training cost Staff reallocation Simplified HR management Facilitated lab organization &workflow- Very limited hands on time: 2 pipetingsteps & 1 heating step- Salmonella, E. coli O157 & QI analysescan be made from the same bag- 1 training day- 18 to 24h enrichment time-72h storage at 2-8C of the incubatedBPW (3 days)- 1 month storage of the VIDAS kit atroom temperature- Storage of the supplement 10h at roomtemperature or 4 days at 2-8 C2010 IAFP; Food Safety Innovation Award12

VIDAS UP Salmonella data for validations13

SPT – AOAC RI approvalsMeat – ground beef, beef trim, deli roast beefPoultry – chicken rinse, ground turkey, deli turkeySeafood – raw cod, cooked shrimpDairy – non-fat dry milk, ice cream, American cheeseEgg – powdered egg, liquid eggMiscellaneous – chocolate, almonds, black pepper, pet foodEnvironmental - ceramic tile, stainless steel, plastic14

SPT vs Molecular Comparison Study15

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Product Assay TotalPresumpConfirmPositivesChart/ Samples graph Positives exampleRef.MethodChiSquareSig.Diff.Sensitiv.RateBeefTyphimuriumBeefTyphimuriumVIDAS 30 21 21 19 0.29 No 10025 %GDS 30 9 8 19 8.01 Yes 42LettuceEnteritidisLettuceEnteritidisChocolateTennesseeChocolateTennesseeTurkeyInfantisTurkeyInfantisChickenHadarChickenHadarVIDAS 25 24 24 23 0.35Line ANoLine B Line C10413 %GDS 25 13 12 23 18.88 Yes 4337 %VIDAS 30 17 17 23 2.85 No 743 %Line D Line E OthersGDS 30 18 18 23 1.89 No 7816 %VIDAS 25 20 20 19 0.11 No 1056 %GDS 25 14 14 19 2.18 No 78VIDAS 30 28 28 29 0.34 No 97GDS 30 26 26 29 1.93 No 9017

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Product Assay TotalPresumpConfirmPositivesChart/ Samples graph Positives exampleRef.MethodChiSquareSig.Diff.Sensitiv.RateBeefTyphimuriumBeefTyphimuriumVIDAS 30 21 21 19 0.29 No 10025 %BAX 30 14 11 19 4.20 Yes 57LettuceEnteritidisLettuceEnteritidisChocolateTennesseeChocolateTennesseeTurkeyInfantisTurkeyInfantisChickenHadarChickenHadarVIDAS 25 24 24 23 0.35Line ANoLine B Line C10413 %BAX 25 23 23 23 0.00 No 10037 %VIDAS 30 17 17 23 2.85 No 743 %Line D Line E OthersBAX 30 22 22 23 0.87 No 9616 %VIDAS 25 20 20 19 0.11 No 1056 %BAX 25 19 19 19 0.00 No 100VIDAS 30 28 28 29 0.34 No 97BAX 30 29 29 29 0.00 No 10019

Conclusion from MolecularComparison Study“VIDAS SPT was found to perform equivalent to or betterthan BAX and GDS for recovery of Salmonella from variousfoods. In conclusion, VIDAS UP SPT can be used as arapid method to identify Salmonella at low levels in groundbeef, lettuce, chocolate, deli and cooked ready-to-eatchicken.”20

VIDAS UPA new generation in pathogen detection technologyE. coli 0157 – ECPT – 2008Salmonella – SPT – Q2 2011Listeria – LPT – Q4 2011