r Programmable Benchtop analyzer 2 independent 24-well Thermal
Cyclers (two tests simultaneously) Windows XP operating Sytems
AmpliLink 3.0.1 Software First Real Time PCR Platform that Offers
IVD & Utility Channel mode Run sizes of 6-48 samples
Slide 5
r COBAS TaqMan with open thermalcycler
Slide 6
r COBAS TaqMan Analyzers Common Features and Benefits Feature
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
Slide 7
r COBAS TaqMan 48 Thermal Cyclers TC lid TC cover
Slide 8
r K-tube, K-carrier, K-carrier holder K-tube K-carrier Holder
K-carrier with barcode
Slide 9
r COBAS TaqMan 48 K-carrier Transporter
Slide 10
r COBAS TaqMan 48 Motorized K-tube Capper
Slide 11
r Post Launch improvements K-Plate & K-caps in new
K-carrier design (in development)
Slide 12
r High Pure System Viral Nucleic Acid Kit Overview
Slide 13
r COBAS TaqMan 48 Workflow with manual or automated sample prep
Manual Sample Prep Automated Sample Prep July 2004 September
2003
Slide 14
r 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
Slide 15
r High Pure System Viral Nucleic Acid Kit/COBAS TaqMan TM HBV
Test Performance
Slide 16
r High Pure System / COBAS TaqMan HBV Linearity/Dynamic Range
Study HPS/CTM HBV linear range = 30 - 1.1E8 IU/ml
Slide 17
r 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%
Slide 18
r Roche HBV MONITOR Tests Comparison
Slide 19
r Technical Comparisons COBAS AMPLICOR HBV MONITOR (300-200,000
copies/ml) High Pure System/COBAS TaqMan HBV (170-6.4E8 copies/ml,
95% at 35 copies/mL) COBAS AMPLICOR HBV MONITOR (1000-4E7
copies/ml) sensitivity, samples detected below A HBM & CA HBM
LOD in upper end of linear range, in number of samples requiring
dilution or repeat testing
Slide 20
r High Pure System Viral Nucleic Acid Kit/COBAS TaqMan TM HCV
Test Performance
Slide 21
r HighPure System/COBAS TaqMan HCV Test Limit of Detection
SerumPlasma (EDTA)
Slide 22
r High Pure System/COBAS TaqMan HCV Test Linearity/Dynamic
Range Study - Serum HPS/CTM HCV linear range = 30 - 2E8 IU/ml
Slide 23
r High Pure System/COBAS TaqMan HCV Test Linearity/Dynamic
Range Study - Serum
Slide 24
r High Pure System/COBAS TaqMan HCV Test Specificity
Slide 25
r Technical Comparisons COBAS AMPLICOR HCV MONITOR (600-500,000
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 AMPLICOR HCV MONITOR (600-850,000
IU/mL/mL)
Slide 26
r Comparison CA HCM v. HPS/CTM HCV
Slide 27
r High Pure System/COBAS TaqMan HCV Test Correlation to Bayer
Versant HCV bDNA 3.0
Slide 28
r Comparison HPS/CTM HCV vs. Bayer VERSANT bDNA
Slide 29
r High Pure System Viral Nucleic Acid Kit/COBAS TaqMan TM HIV-1
Test Performance
Slide 30
r 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
Slide 31
r HighPure/COBAS TaqMan 48 HIV-1 Test: Specificity
Slide 32
r 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
Slide 33
r HighPure/COBAS TaqMan 48 HIV-1 Test: Interference of HIV
Antiviral Drugs
Slide 34
r Roche HIV-1 MONITOR Tests Comparison
Slide 35
r TaqMan Assay Principle: 5Nuclease
Slide 36
r Additional Instrumentation required Water bath - 50 C Sigma
Bench Top Centrifuge - 4600 g Centrifuge art 10732 Swing Out Rotor
art.11118 Check Price at local Sigma Distributors (Export)
Slide 37
r HPS/CTM HCV Test Performance Characteristics Sensitivity: 10
IU/ml Dynamic Range: 30 - 2E8 IU/ml Specificity: >99.99%
Genotype inclusivity: 1-6 Sample Input: 500 l EDTA Plasma or Serum
Time to Result: ~ 5 hours
Slide 38
r TaqMan Reagents: Performance for HBV (report in IU/ml)
r 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
Slide 42
r 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