cobas ® 4800 system innovation that simplifies page 1 © 2014 roche
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cobas® 4800 SystemInnovation that Simplifies
page 1 © 2014 Roche
cobas 4800 SystemInnovation made Simple
Minimal System Maintenance• Daily / Weekly maintenance requires ~ 2 – 7 minutes • No bleaching of the system or components• No Monthly maintenanceAutomated Specimen Preparation• Designed for pipetting directly from primary or secondary vial for
specimens with reduced volume, Secondary vial requires only 1 mL of volume
• On board bar-code scanner for positive patient identification• Reagents are ready to use• Air displacement system, no system fluids or priming cycles
Innovative System Design CO-RE Tips designed to reduce aerosols that can cause contamination TADM to ensure accurate sample and reagent pipetting LightCycler® Technology used for many years with the LightCycler®
instrument
cobas 4800 System
23 inches
cobas x 480 instrument
• Testing from primary and secondary specimen tube
• Specimen barcodes automatically read by system for positive specimen ID
• Batches of 24 or 96
cobas z 480 analyzer• Real-Time PCR• Based on LightCycler®
technology• 96 well plate format• 4 channel detection
66 inches
© 2014 Roche
HPV/HPV Genotype tests, CT/NG, and oncology markers & others on the same system
© 2014 Roche
HPV
CT / NG
cobas 4800 v2.0
BRAF
EGFR
EGFR RUO*
PI3K RUO*
KRAS RUO*
cobas 4800 v2.11
HPV, CT/NG, HSV1
BRAF, EGFR,
PI3K1, KRAS1
MRSA1/MSSA1, Cdiff1
* For Research Use Only. Not for use in diagnostic procedures. 1 Product is not available in the US. In development for the cobas 4800 system.
cobas 4800 v1.1
© 2014 Roche
PlateCarrier
Tip Carrier 1
Tip Carrier 2
StationaryCarrier
ReagentLoading
Area
cobas x 480 InstrumentInstrument Deck Overview
SampleLoadingArea
© 2014 Roche
Daily Maintenance• Once every 24 hrs.• Requires 2 – 7 min. of operator
time• No Bleaching of system
components
Preventive Maintenance Status• Performed bi-annually by
Roche Field Service
Weekly Maintenance • Includes daily maintenance• Operator should wipe down
carriers with water
cobas® 4800 SystemRequires Minimal Maintenance
No Monthly Maintenance
Sample Carriers
cobas x 480 Instrument Positive patient ID
• Specimen loading area holds up to 94 specimens
• 24 sample carriers & 12 sample carrier can be combined for a total of 94 samples on board for the cobas HPV test
• Specimen bar-codes are read by the on board barcode reader as the specimen carrier is loaded.
• The software links the specimen to the order providing positive specimen identification through out the testing process.
12 sample carrierholds up to 12 PreservCyt vials
24 sample carrier holds up to 24 PCR Media tubes or 24 Sarstedt tubes
© 2014 Roche
© 2014 Roche
Load samples1. Uncap samples.2. Place samples on corresponding carrier.3. Insert sample carriers on autoload tray.4. Click Load Samples.
cobas x 480 InstrumentLoad Samples and Work Order File
cobas x 480 Instrument Designed for reliabilityDesign Benefit
CO-RE tip technology • Reduces aerosol production upon tip ejection • Improved system reliability
Air Displacement Pipetting with total aspirate and dispense monitoring (TADM)
• Verifies sample transfer with digital audit trail• Liquid class optimization for all reagents and sample types• Detects pipetting errors during the aspiration step in real time
Anti-droplet control • Reduces droplet production from evaporative expansion in the tip• Reduces a source of contamination
Dynamic Positioning System
• Flexible, precise tip positioning• Adapts to any specimen container
© 2014 Roche
CO-RE Tip TechnologyCompression-Induced O-Ring Expansion
• Secure, air-tight tip seal • Gentle release to reduce
aerosol formation• Reduced mechanical
strain for reliability
O-ring
TipO-ring
groove
PistonO-ring in
groove
Tips locked in place by an O-ring that fits into a groove inside the neck of the tip
© 2014 Roche
© 2014 Roche
cobas x 480 InstrumentAspiration and Dispense Monitoring
• Reagent Carriers
cobas x 480 Instrument Instrument Deck Overview
200 ml Reagent Reservoir
50 ml Reagent Reservoir
Assay Specific Reagents
© 2014 Roche
cobas x 480 InstrumentStationary Carrier
Heater / Shaker
Magnetic Plate
Home position for DWP
Loading position forPCR Plate
© 2014 Roche
cobas x 480 InstrumentSample Preparation on the stationary carrier
Lyse Bind Wash Elute
Heater / Shaker• Lyse• Bind to Magnetic glass particle
Magnetic Plate• Wash steps
Extraction (deep well plate) holder• Sample and reagent addition
AD Plate holder• Extracted specimen + Master Mix
© 2014 Roche
cobas z 480 Analyzer
© 2014 Roche
© 2014 Roche
cobas z 480 InstrumentSeal Microwell plate and begin real-time PCR
• Following sample preparation
the AD plate is sealed and moved to the cobas z 480 analyzer
• The sealed plate is placed on the loader and the Real-time PCR begins when the load button is pressed and the plate is pulled into the cobas z 480 analyzer
• Positive specimen ID is maintained via the bar-coded microwell plate
© 2014 Roche
cobas z 480 System High Performance Real-Time PCR
Design Benefit
Unique fluid filled Therma-Based layer in the block provides uniform heating and cooling across the entire plate
• Shortened cycle times • Improved temperature
homogeneity• Improved accuracy
cobas z 480 analyzerHigh Performance Real-Time PCR
Design Benefit
Single step processing with few moving parts
• More reliable• More reproducible
High performance optical system with 5 optical channels
• Multiple target detection from a single reaction tube
• Accurate data capture across the entire plate
Advanced Digital Optics Design
© 2014 Roche
• Instrument-level processing corrects for optical system variability
• Filter design and manufacturing process minimized spectral cross-talk
• Primary data reduction algorithm is fluorescence scale invariant
• No more simplistic threshold methods for Ct calculations
Multivariable AlgorithmEliminate the guessing game
Expanding System Capabilities User Defined Workflow software
Design Benefit
Dual boot setup with a partitioned hard drive and separate database
Based on the LightCycler® 480 Software v.1.5
• Full functionality of the current LightCycler® software
• Allows user defined assay development to expand menu
• Limited training required for customers already familiar with the LightCycler® 480 Analyzer
© 2014 Roche
© 2014 Roche
cobas 4800 SystemResults
RunsTest Results
Accept Results
Print Report
cobas® 4800 System Workflow
© 2014 Roche
cobas 4800 system Process Map for 96 samplesRequires minimal hands on time; frees staff to perform other tasks in the laboratory
Source: Argent Global Services
Maintenance
• Daily / Weekly• No Monthly• Bleach is
never used on the cobas 4800 system
Load
• Samples in primary or secondary vials
• Consumables• Reagents, no
preparation required
Sample Preparati
on
• Directly from primary vial or secondary vial
• PCR ready plate is transferred to cobas z 480 Analyzer (1 min)
Real-Time PCR
• Multiplex Real-time PCR with multiple targets in one reaction
End of run clean
up
• Dispose of extraction plate
• Dispose of reagent reservoirs and tubes
• Dispose of AD plate
2 – 7 min
16 – 30 min
102 – 167 min
86 – 120min
~8 min
Walk Away Time
cobas® HPV Test96 HPV results with genotyping for 16& 18 in 5 hrs.no reflex testing required
Source: Argent Global Services, 2012
96 HPV Samples
24 HPV Samples
1 hr 2 hr 3 hr 4 hr 5 hr 6 hr 7 hr
146 min.
120 min.30
8 hr
83 min. 120 min.16
cobas HPV TestParallel testing provides flexibility
Source: Argent Global Services, 2012
24 HPV Samples
48 HPV Samples
72 HPV Samples
96 HPV Samples
1 hr 2 hr 3 hr 4 hr 5 hr 6 hr 7 hr 8 hr 9 hr 10 hr
83 min 120 min16
96 fully automated HPV with types 16 & 18 in 5 hoursHigh volume throughput – 288 results in under 12 hrs
96 HPV Samples
192 HPV Samples
288 HPV Samples
384 HPV Samples
1 hr 2 hr 3 hr 4 hr 5 hr 6 hr 7 hr
146 min.
120 min.
30
8 hr 9 hr 10 hr 12 hr
11 hr
13 hr
14 hr
Source: Argent Global Services, 2012
HPV Comparison StudyLeast amount of hands on time
Source: HPV Comparison Study; Argent Global Services, 2010
*Cervista hrHPV test performed on the Tecan DNA Extractor with the ABI 9700 Thermalcycler** hc2 HPV test performed with the Rapid Capture System
cobas HPV test hc2 HPV test Cervista hrHPV test
# of Reportables 94 88 48
Hands-On Time (min.) 33.17 149.02 129.01
Hands-On Time (min.) without daily man=intenance 29.3 142.71 125.84
Total Cycle Time (min.) without Daiuly Maintenance 295.84 404.64 471.43
Total Cycle Time (min.) 299.71 416.5 476.64
Walk-Away Time (min.) 266.55 248.97 309.19
Walk-Away Time (% of Total) 90% 62% 66%
Daily Maintenance Time (min.) 3.87 11.86 5.21
HPV Comparison StudyReduced time to results with minimal hands on time
Source: HPV Comparison Study; Argent Global Services, 2010
# of Reportables Hands-On Time (min.) Total Cycle Time (min.) Walk-Away Time (% of Total)
0
60
120
180
240
300
360
420
480
cobas HPV testhc2 HPV testCervista hrHPV test
cobas HPV test hc2 HPV test Cervista hrHPV test# of Reportables 94 88 48Hands-On Time (min.) 33.17 149.02 129.01Total Cycle Time (min.) 299.71 416.5 476.64Walk-Away Time (% of Total) 90% 62% 66%
Includes daily maintenance
cobas CT/NG v2.0 TestWorkflow
16
27 153 86
102 86
16
86
86105
28 167
1 hr 2 hr 3 hr 4 hr 5 hr
cobas CT/NG v2.0 TestParallel Testing
1 hr 2 hr 3 hr 4 hr 5 hr 6 hr
1 hr 2 hr 3 hr 4 hr 5 hr 6 hr 7 hr 8 hr
25,000 tests / year
50,000 tests / year
cobas CT/NG v2.0 TestParallel testing flexibility with HPV
1 hr
2 hr 3 hr 4 hr 5 hr 6 hr 7 hr 8 hr 9 hr 10 hr
11 hr
1 hr 2 hr 3 hr 4 hr 5 hr 6 hr 7 hr 8 hr
CT/NG Assay Comparison StudyMinimal system maintenance, minimal hands on time
Source: CT/NG Comparison Study; Argent Global Services, 2012
cobas 4800
CT/NG
Abbott m2000 CT/NG
BD Viper CT/NG
Hologic Panther
HologicTigris CT/NG
# of Reportables 94 92 92 98 96
Hands-On Time (min.) 39.84 50.55 87.36 50.15 88.6
Hands-On Time (min.) without Daily Maintenance
35.99 39.45 66.48 36.21 53.76
Total Cycle Time (min.) 278.87 380.01 270.11 371.86 359.04
Total Cycle Time (min.) without Daily Maintenance
275.02 368.91 249.23 357.92 321.11
Walk-Away Time (% of total)
86% 81% 62% 87% 75%
Walk-Away Time (% of total) without Daily Maintenance
87% 83% 67% 90% 83%
Source: CT/NG Comparison Study; Argent Global Services, 2012
cobas CT/NG testLeast amount of hands on time
Includes daily maintenance
cobas 4800
CT/NGAbbott m2000
CT/NGBD Viper CT/NG
Hologic Panther
HologicTigris CT/NG
Hands-On Time (min.) 39.84 50.55 87.36 50.15 88.6
Total Cycle Time (min.) 278.87 380.01 270.11 371.86 359.04
Walk-Away Time (% of total) 86% 81% 62% 87% 75%