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• TEMPO® Concept • Workflow
• bioMerieux • TEMPO® Concept • Workflow • Test Menu • Official Validations Jamaica, NY 5/30/2008 Philippe Villard, Business Development Manager, Quality Indicators
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• TEMPO® Concept • Workflow
• bioMerieux • TEMPO® Concept • Workflow • Test Menu • Official Validations Philippe Villard, Business Development Manager, Quality Indicators
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bioMérieux develops, produces and markets solutions composed of: Instruments, Reagents & Software.
• Clinical Diagnostic • Industrial Diagnostic (Food, Pharmaceutical & Cosmetic)
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Research & Development
Lyon : Marcy, Craponne, La Balme (France) Boxtel (Netherlands) Saint Louis Grenoble (USA) (France) Durham (USA) Sao Paulo (Brazil) Florence (Italy) OVER 850 12.5% OF 400 FAMILIES 9 R&D SITES EMPLOYEES SALES OF PATENTS INVESTED
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bioMerieux Solutions Culture Media
Manual Identification BioBallTM for Quantitative QC
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bioMerieux Solutions Vitek 2 Compact® for bacterial Enumeration
diversilabTM for genotyping
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bioMerieux Solutions VIDAS® for Pathogen Detection
BacT/Alert® for Spoilage Organism Detection TEMPO® for Quality Indicator Quantification
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• TEMPO® Concept • Workflow
• bioMerieux • TEMPO® Concept • Workflow • Test Menu • Official Validations Philippe Villard, Business Development Manager, Quality Indicators
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From the Traditional Approach
1 ml 1 ml 1 ml + 90 ml 10 g of product 10-1 10-2 10-3 10-4 I n c u b a t i o n CFU/ g Interpretation 3 + 2 + 2 + acc to statistical 3/2/2 Counting table
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To an Innovative Solution
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TEMPO Protocol Automated Reading + Diluent
Sample + dehydrated specific culture media Automated Filling of the card Standard Incubation Automated Reading 3,7 Log count Automated discrimination of positive and negative wells Enumeration range ! Most Probable Number computing 2 / 0 / 0 Statistic table + dilution factor Enumeration (cfu/g)
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Bacterial Growth Detection
non fluorescent fluorescent Total Viable Count E.coli 4MU-X 4MU Bacterial specific enzymatic activity Media acidification due to carbohydrate metabolism Enterobacteriaceae Coliforms 4MU 4MU fluorescent non fluorescent
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Enumeration Range MPN 16 tubes = 3.7 log of range 1 10 -1 102 -2 103
Sample 1 4.9x103 cfu/g Dilution 3.7 log 10 4.9x104 cfu/g -1 102 4.9x105 cfu/g -2 103 4.9x106 cfu/g -3 104 4.9x107 cfu/g -4
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TEMPO TVC 102 - 4.9.105 cfu/g TEMPO CC 10 - 4.9.104 cfu/g TEMPO EC
0.1mL cfu/g 1mL TEMPO CC cfu/g Diluted Sample 1mL TEMPO EC cfu/g No dilution tubes (reduce turn around time, reduce testing bias) Standardized Preparation, Reading & Recording of the tests Improves accuracy and reproducibility of the tests
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• TEMPO® Concept • Workflow
• bioMerieux • TEMPO® Concept • Workflow • Test Menu • Official Validations Philippe Villard, Business Development Manager, Quality Indicators
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Tomorrow with TEMPO® Today… 2- Sample preparation 1- Media preparation
3- Dilution 4-Inoculation 5- Filling 8-Reporting 7-Reading 6-Incubation
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TEMPO Workflow (Video)
Sample preparation Inoculation Incubation Reading & interpretation
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TEMPO® Test Results Trending Analysis
Sample ID Test Dilution (1/) Preparation Date Status CFU/G Annotations Comments 05\3382 TVC 40000 lun. 21/03/ :23 OK = 05\3382 CC 40 lun. 21/03/ :23 OK = 4800 05\3382 EC 40 lun. 21/03/ :24 OK < 10 05\3398 TVC 4000 lun. 21/03/ :27 OK = 05\3398 CC 40 lun. 21/03/ :28 OK = 930 05\3398 EC 40 lun. 21/03/ :28 OK < 10 05\3617 TVC 4000 lun. 21/03/ :32 OK > 05\3617 CC 40 lun. 21/03/ :32 OK = 1800 05\3617 EC 40 lun. 21/03/ :33 OK = 10 05\3618 TVC 4000 lun. 21/03/ :38 OK = 25000 05\3618 CC 40 lun. 21/03/ :38 OK = 10 05\3618 EC 40 lun. 21/03/ :45 OK < 10 05\3621 TVC 4000 lun. 21/03/ :47 OK = 05\3621 CC 40 lun. 21/03/ :48 OK = 240 Trending Analysis
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TEMPO® - Time Saving = Resource Allocation
Based on external independent studies : Tempo saves from 25 to 80% labor time! Labor hours required per steps and per day In hours 4.5 Plate Method QI 3.0 -70 samples 2.5 -200 QI tests/day 2.0 1.5 0.0 Sample Preparation Media preparation Tubes preparation Identification/ Dilution/ Reading and Washing if necessary Inoculation / Filling Recording
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TEMPO : Throughput 500 tests prepared in 1 day by 1 operator
500 tests read & reported in < 2 hours by 1 operator
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• TEMPO® Concept • Workflow
• bioMerieux • TEMPO® Concept • Workflow • Test Menu • Official Validations Philippe Villard, Business Development Manager, Quality Indicators
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TEMPO test kits Available Total Viable Count Enterobacteriaceae
Coliform Count Generic E.coli • Current Developments • Staphylococcus aureus • Launch July 2008 • Lactic Acid Bacteria • Launch July 2008 • Yeasts & Molds • Launch 1st Quarter 2009
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• TEMPO® Concept • Workflow
• bioMerieux • TEMPO® Concept • Workflow • Test Menu • Official Validations Philippe Villard, Business Development Manager, Quality Indicators
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Continuous Official & International Approvals
AOAC Research Institute • Total Viable Count • Enterobacteriaceae • Coliforms • E.coli AOAC OMA • Total Count: Approval Pending • E.coli & Coliforms: In progress ISO 16140 • Total Viable Count • Enterobacteriaceae • Coliforms • E.coli
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Thank you Philippe Villard, Business Development Manager, Quality Indicators
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