1. COBAS TaqMan 48 Sales Brochure

2. COBAS TaqMan 48 Product Presentation

3. Evolution of Roche Diagnostics Platforms (RMD)
Degree of Automation
MWP
COBAS
AMPLICOR
COBAS AMPLIPREP
Automated
Sample
Preparation
AMPLIPREP&
COBAS TaqMan 96/
TaqMan 48
AMPLILINK
MONITOR
COBAS TaqMan 48

4. COBAS TaqMan 48
First Real Time PCR Platform that Offers IVD & Utility Channel mode
Programmable Benchtop analyzer
2 independent 24-well Thermal Cyclers (two tests simultaneously)
AmpliLink Software
Windows XP operating Sytems
Run sizes of 6-48 samples

5. COBAS TaqMan with open thermalcycler

6. COBAS TaqMan Analyzers Common Features and Benefits
Kinetic PCR
Integrated Quantification Standard requires no external standard curves
Closed Tube Format
Four color channels (upgrade to six planned)
Sample vessel: k-tube or k-plate
Benefit
Broad dynamic range
No separate detection
Assay time reduction from 6h to 2-3 hours
Increases Throughput
Provides internal control
Eliminates contamination risk
Allows multiplexing
Will allow additional formats (Hybridization Probes)
Easy handling
Automation through AmpliPrep

7. COBAS TaqMan 48 Thermal Cyclers
TC lid
TC cover

8. K-tube, K-carrier, K-carrier holder
K-carrier with
barcode

9. COBAS TaqMan 48
K-carrier
Transporter

10. COBAS TaqMan 48
MotorizedK-tube
Capper

11. Post Launch improvements
K-Plate & K-caps in new K-carrier design (in development)

12. High Pure System Viral Nucleic Acid Kit Overview

13. COBAS TaqMan 48 Workflow with manual or automated sample prep
Manual Sample Prep
September 2003
Automated Sample Prep
July 2004

14. High Pure System Viral Nucleic Acid Kit (redesigned - 12 samples format)
1 = Lysis Rack
2 = Filter Tube Rack
3 = Waste Container
4 = Elution Rack
5 = Cover Rack
6 = Grippers
One kit = 48 preps
4 plates with 12 Columns per plate; Lysis, Filter, Elution Rack

15. High Pure System Viral Nucleic Acid Kit/COBAS TaqMan TM HBV Test Performance

16. High Pure System / COBAS TaqMan HBV Linearity/Dynamic Range Study
y = x R 2 =
Error Bars = 1 Standard Deviation
-1.00
0.00
1.00
2.00
3.00
4.00
5.00
6.00
7.00
8.00
9.00
Nominal Concentration
Log 10
(HBV DNA IU/ml)
High Pure System Viral Nucleic Acid
Kit / COBAS TaqMan HBV Test Result
(HBV DNA IU/mL)
HPS/CTM HBV linear range = E8 IU/ml

17. High Pure System / COBAS TaqMan HBV - Limit of Detection Study
HPS/CTM HBV can detect HBV DNA in EDTA-plasma and serum at concentrations as low as 5.9 IU/ml with a positivity rate greater than 95%

18. Roche HBV MONITOR Tests Comparison

19. Technical Comparisons
 sensitivity,  samples detected below A HBM & CA HBM LOD
 in upper end of linear range,  in number of samples requiring dilution or repeat testing
COBAS AMPLICOR HBV MONITOR (1000-4E7 copies/ml)
COBAS AMPLICOR HBV MONITOR ( ,000 copies/ml)
High Pure System/COBAS TaqMan HBV ( E8 copies/ml, 95% at 35 copies/mL)

20. High Pure System Viral Nucleic Acid Kit/COBAS TaqMan TM HCV Test Performance

21. HighPure System/COBAS TaqMan HCV Test Limit of Detection
Plasma (EDTA)
Serum

22. HPS/CTM HCV linear range = 30 - 2E8 IU/ml
High Pure System/COBAS TaqMan HCV Test Linearity/Dynamic Range Study - Serum
HPS/CTM HCV linear range = E8 IU/ml

23. High Pure System/COBAS TaqMan HCV Test Linearity/Dynamic Range Study - Serum

24. High Pure System/COBAS TaqMan HCV Test Specificity

25. Technical Comparisons
AMPLICOR™ HCV MONITOR ( ,000 IU/mL/mL)
COBAS AMPLICOR™ HCV MONITOR ( ,000 IU/mL/mL)
High Pure System/COBAS TaqMan™ Test HCV (30->2E8 IU/mL, LOD = 95% at 10 IU/mL)
 sensitivity,  samples detected below CA HCM LOD
 in upper end of linear range,  in number of samples requiring dilution or repeat testing

26. Comparison CA HCM v. HPS/CTM HCV

27. High Pure System/COBAS TaqMan HCV Test Correlation to Bayer Versant HCV bDNA 3.0

28. Comparison HPS/CTM HCV vs. Bayer VERSANT® bDNA

29. High Pure System Viral Nucleic Acid Kit/COBAS TaqMan TM HIV-1 Test Performance

30. HighPure/COBAS TaqMan 48 HIV-1 Test: Linear Range
Data support: 37 cp/mL to 1.03E7 cp/mL
Claim: 40 cp/mL - 1E7 cp/mL

31. HighPure/COBAS TaqMan 48 HIV-1 Test: Specificity

32. HighPure/COBAS TaqMan 48 HIV-1 Test: Interference of Clinical Specimens
No Interference of Clinical Specimens Infected with HTLV-1, HTLV-2,
HIV-2, HAV, HBV, HCV and EBV

33. HighPure/COBAS TaqMan 48 HIV-1 Test: Interference of HIV Antiviral Drugs

34. Roche HIV-1 MONITOR Tests Comparison

35. TaqMan™ Assay Principle: 5‘Nuclease

36. Additional Instrumentation required
Water bath - 50 C
Sigma Bench Top Centrifuge g
Centrifuge art 10732
Swing Out Rotor art.11118
Check Price at local Sigma Distributors (Export)

37. HPS/CTM HCV Test Performance Characteristics
Sensitivity: IU/ml
Dynamic Range: E8 IU/ml
Specificity: >99.99%
Genotype inclusivity: 1-6
Sample Input: µl EDTA Plasma or Serum
Time to Result: ~ 5 hours

38. TaqMan Reagents: Performance for HBV (report in IU/ml)

39. TaqMan Reagents: Performance for HIV-1

40. Future Parameters COBAS TaqMan® 48 AnalyzerCT
CT/NG
CMV
HSV 1,2
FV Leiden
Prothrombin (G20210A)
Cytochrome P450 2C9

41. COBAS TaqMan
COBAS TaqMan integrates amplification and detection in a homogenous fluorescent assay format for easy quantification of target copy numbers
Real Time data collection allows monitoring of the PCR process in each individual cycle instead of end point measurement after completion of all cycles
Closed tube format safeguards against potential product carry over contamination
Kinetic measurement broadens the dynamic range of our virological assays to provide accurate viral load information
TaqMan technology is a more sensitive and reproducible method for viral load monitoring and thereby enables better treatment decisions
Roche Molecular Diagnostics continues to make PCR testing routine in the clinical laboratory with the benefits provided by the COBAS TaqMan Analyzer.

42. Advantages of the Taqman® Tests
Single-tube amplification and real time detection: QS and Target
Eliminates post-PCR manipulations
Closed system: minimizes contamination
Fewer reagents and disposables required
Sensitive and probe-specific
Broad dynamic range
Walk-away system
Small volume of tests/ day