biomerieux tempo ® concept workflow test menu official validations jamaica, ny 5/30/2008 philippe...
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• bioMerieux • TEMPO®
Concept • Workflow • Test Menu
• Official Validations
Jamaica, NY 5/30/2008
Philippe Villard, Business Development Manager, Quality Indicators
• 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 Florence (Brazil)
(Italy)
12.5% OF OVER 850 400 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
• 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 10-4 10-2 10-3
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
+ Diluent
Sample + dehydrated specific culture media
Automated Filling of the card
Standard Incubation
Automated Reading
3,7 Log count Enumeration range ! Automated discrimination of positive and negative wells
Most Probable Number computing 2 / 0 / 0
Statistic table + dilution factor
Enumeration (cfu/g)
Bacterial Growth Detection
non fluorescent fluorescent
Total Viable Count 4MU-X E.coli
4MU Bacterial
specific enzymatic activity
Media acidification due to carbohydrate metabolism Enterobacteriaceae
Coliforms
4MU 4MU non fluorescent fluorescent
Enumeration Range
MPN 16 tubes = 3.7 log of range
Sample 4.9x103 cfu/g 1 Dilution 3.7 log
0 10 4.9x104 cfu/g
-1 4.9x105 cfu/g 102
-2 103 4.9x106 cfu/g
-3 4.9x107 cfu/g 104
-4
TEMPO TVC 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
• bioMerieux • TEMPO®
Concept • Workflow • Test Menu
• Official Validations
Philippe Villard, Business Development Manager, Quality Indicators
Today… Tomorrow with TEMPO®
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
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 2.0 tests/day 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
• bioMerieux • TEMPO®
Concept • Workflow • Test Menu
• Official Validations
Philippe Villard, Business Development Manager, Quality Indicators
TEMPO test kits
Total Viable Count
Enterobacteriaceae Available
Coliform Count
Generic E.coli
• Current Developments • Staphylococcus aureus • Launch July 2008
• Lactic Acid Bacteria • Launch July 2008
• Yeasts & Molds • Launch 1st Quarter 2009
• 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