• TEMPO® Concept • Workflow

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Presentation transcript:

• TEMPO® Concept • Workflow • bioMerieux • TEMPO® Concept • Workflow • Test Menu • Official Validations Jamaica, NY 5/30/2008 Philippe Villard, Business Development Manager, Quality Indicators

• TEMPO® Concept • Workflow • bioMerieux • TEMPO® Concept • Workflow • Test Menu • Official Validations Philippe Villard, Business Development Manager, Quality Indicators

bioMérieux develops, produces and markets solutions composed of: Instruments, Reagents & Software. • Clinical Diagnostic • Industrial Diagnostic (Food, Pharmaceutical & Cosmetic)

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

bioMerieux Solutions Culture Media Manual Identification BioBallTM for Quantitative QC

bioMerieux Solutions Vitek 2 Compact® for bacterial Enumeration diversilabTM for genotyping

bioMerieux Solutions VIDAS® for Pathogen Detection BacT/Alert® for Spoilage Organism Detection TEMPO® for Quality Indicator Quantification

• TEMPO® Concept • Workflow • bioMerieux • TEMPO® Concept • Workflow • Test Menu • Official Validations Philippe Villard, Business Development Manager, Quality Indicators

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 2.1 104 CFU/ g Interpretation 3 + 2 + 2 + acc to statistical 3/2/2 Counting table

To an Innovative Solution

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)

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

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

TEMPO TVC 102 - 4.9.105 cfu/g TEMPO CC 10 - 4.9.104 cfu/g TEMPO EC 0.1mL 102 - 4.9.105 cfu/g 1mL TEMPO CC 10 - 4.9.104 cfu/g Diluted Sample 1mL TEMPO EC 10 - 4.9.104 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

• TEMPO® Concept • Workflow • bioMerieux • TEMPO® Concept • Workflow • Test Menu • Official Validations Philippe Villard, Business Development Manager, Quality Indicators

Tomorrow with TEMPO® Today… 2- Sample preparation 1- Media preparation 3- Dilution 4-Inoculation 5- Filling 8-Reporting 7-Reading 6-Incubation

TEMPO Workflow (Video) Sample preparation Inoculation Incubation Reading & interpretation

TEMPO® Test Results Trending Analysis Sample ID Test Dilution (1/) Preparation Date Status CFU/G Annotations Comments 05\3382 TVC 40000 lun. 21/03/2005 15:23 OK = 400000 05\3382 CC 40 lun. 21/03/2005 15:23 OK = 4800 05\3382 EC 40 lun. 21/03/2005 15:24 OK < 10 05\3398 TVC 4000 lun. 21/03/2005 15:27 OK = 1700000 05\3398 CC 40 lun. 21/03/2005 15:28 OK = 930 05\3398 EC 40 lun. 21/03/2005 15:28 OK < 10 05\3617 TVC 4000 lun. 21/03/2005 15:32 OK > 4900000 05\3617 CC 40 lun. 21/03/2005 15:32 OK = 1800 05\3617 EC 40 lun. 21/03/2005 15:33 OK = 10 05\3618 TVC 4000 lun. 21/03/2005 15:38 OK = 25000 05\3618 CC 40 lun. 21/03/2005 15:38 OK = 10 05\3618 EC 40 lun. 21/03/2005 15:45 OK < 10 05\3621 TVC 4000 lun. 21/03/2005 15:47 OK = 910000 05\3621 CC 40 lun. 21/03/2005 15:48 OK = 240 Trending Analysis

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 4.0 3.5 3.0 -70 samples 2.5 -200 QI tests/day 2.0 1.5 1.0 0.5 0.0 Sample Preparation Media preparation Tubes preparation Identification/ Dilution/ Reading and Washing if necessary Inoculation / Filling Recording

TEMPO : Throughput 500 tests prepared in 1 day by 1 operator 500 tests read & reported in < 2 hours by 1 operator

• TEMPO® Concept • Workflow • bioMerieux • TEMPO® Concept • Workflow • Test Menu • Official Validations Philippe Villard, Business Development Manager, Quality Indicators

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

• TEMPO® Concept • Workflow • bioMerieux • TEMPO® Concept • Workflow • Test Menu • Official Validations Philippe Villard, Business Development Manager, Quality Indicators

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

Thank you Philippe Villard, Business Development Manager, Quality Indicators