cobas ® 4800 System

Report
cobas® 4800 System
Innovation that Simplifies
page 1 © 2014 Roche
cobas 4800 System
Innovation made Simple
Minimal System Maintenance
• Daily / Weekly maintenance requires ~ 2 – 7 minutes
• No bleaching of the system or components
• No Monthly maintenance
Automated 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
66
inches
23
inches
cobas x 480 instrument
cobas z 480 analyzer
• Testing from primary and secondary
• Real-Time PCR
• Specimen barcodes automatically
positive specimen ID
• Based on LightCycler®
technology
• Batches of 24 or 96
• 96 well plate format
• 4 channel detection
© 2014 Roche
HPV/HPV Genotype tests, CT/NG, and
oncology markers & others on the same system
cobas 4800 v1.1
cobas 4800 v2.0
cobas 4800 v2.11
HPV
BRAF
HPV, CT/NG, HSV1
CT / NG
EGFR
BRAF, EGFR,
EGFR RUO*
PI3K1, KRAS1
PI3K RUO*
MRSA1/MSSA1, Cdiff1
KRAS RUO*
* 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.
© 2014 Roche
cobas x 480 Instrument
Instrument Deck Overview
Plate
Carrier
Tip Carrier 2
Stationary
Carrier
Tip Carrier 1
Sample
Loading
Area
Reagent
Loading
Area
© 2014 Roche
cobas® 4800 System
Requires Minimal Maintenance
Daily Maintenance
•
•
•
Once every 24 hrs.
Requires 2 – 7 min. of operator time
No Bleaching of system components
Weekly Maintenance
•
•
Includes daily maintenance
Operator should wipe down carriers with water
No Monthly Maintenance
Preventive Maintenance Status
•
© 2014 Roche
Performed bi-annually by Roche Field Service
cobas x 480 Instrument
Positive patient ID
Sample Carriers
24 sample carrier holds up to 24
PCR Media tubes or 24 Sarstedt
tubes
12 sample carrier
holds up to 12 PreservCyt vials
• 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.
© 2014 Roche
cobas x 480 Instrument
Load Samples and Work Order File
Load samples
1.
2.
3.
4.
Uncap samples.
Place samples on corresponding carrier.
Insert sample carriers on autoload tray.
Click Load Samples.
© 2014 Roche
cobas x 480 Instrument
Designed for reliability
Design
Benefit
CO-RE tip technology
• Reduces aerosol production upon tip ejection
• Improved system reliability
Air Displacement Pipetting • Verifies sample transfer with digital audit trail
with total aspirate and
• Liquid class optimization for all reagents and
dispense monitoring
• Detects pipetting errors during the aspiration
(TADM)
Anti-droplet control
• Reduces droplet production from evaporative
• Reduces a source of contamination
Dynamic Positioning
• Flexible, precise tip positioning
• Adapts to any specimen container
© 2014 Roche
CO-RE Tip Technology
Compression-Induced O-Ring Expansion
• Secure, air-tight tip seal
• Gentle release to reduce
aerosol formation
• Reduced mechanical strain
for reliability
Tips locked in place by an
O-ring that fits into a groove
inside the neck of the tip
Piston
O-ring
O-ring in
groove
Tip
O-ring
groove
© 2014 Roche
cobas x 480 Instrument
Aspiration and Dispense Monitoring
© 2014 Roche
cobas x 480 Instrument
Instrument Deck Overview
• Reagent Carriers
Assay Specific
Reagents
50 ml Reagent Reservoir
200 ml Reagent Reservoir
© 2014 Roche
cobas x 480 Instrument
Stationary Carrier
Heater / Shaker
Magnetic Plate
Home position for DWP
Loading position for
PCR Plate
© 2014 Roche
cobas x 480 Instrument
Sample 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
cobas z 480 Instrument
Seal 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
© 2014 Roche
cobas z 480 analyzer
High Performance Real-Time PCR
Design
Benefit
Single step processing with
• More reliable
• More reproducible
High performance optical
optical channels
• Multiple target detection from a single
• Accurate data capture across the
Advanced Digital Optics Design
© 2014 Roche
Multivariable Algorithm
Eliminate the guessing game
• 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
Expanding System Capabilities
User Defined Workflow software
Design
Benefit
Dual boot setup with a partitioned
separate database
• Full functionality of the current
software
• Allows user defined assay
menu
• Limited training required for
familiar with the LightCycler®
Based on the LightCycler® 480
© 2014 Roche
cobas 4800 System
Results
Test Results
Runs
Print Report
Accept Results
© 2014 Roche
cobas® 4800 System Workflow
© 2014 Roche
cobas 4800 system Process Map for 96 samples
Requires minimal hands on time;
frees staff to perform other tasks in the laboratory
Walk Away Time
Source: Argent Global Services
cobas® HPV Test
96 HPV results with genotyping for 16& 18 in 5
hrs.
no reflex testing required
30
146 min.
16
1 hr
2 hr
96 HPV Samples
120 min.
3 hr
83 min.
4 hr
120 min.
5 hr
Source: Argent Global Services, 2012
6 hr
24 HPV Samples
7 hr
8 hr
cobas HPV Test
Parallel testing provides flexibility
16
83 min
120 min
24 HPV Samples
48 HPV Samples
72 HPV Samples
96 HPV Samples
1 hr
2 hr
3 hr
4 hr
5 hr
Source: Argent Global Services, 2012
6 hr
7 hr
8 hr
9 hr
10 hr
96 fully automated HPV with types 16 & 18 in 5 hours
High volume throughput – 288 results in under 12 hrs
30
146 min.
96 HPV Samples
120 min.
192 HPV Samples
288 HPV Samples
384 HPV Samples
1 hr
2 hr
3 hr
4 hr
5 hr
6 hr
7 hr
8 hr
9 hr
Source: Argent Global Services, 2012
10 hr 11 hr
12 hr
13 hr
14 hr
HPV Comparison Study
Least amount of hands on time
cobas HPV test
hc2 HPV test
Cervista hrHPV test
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
# of Reportables
*Cervista hrHPV test performed on the Tecan DNA Extractor with the ABI 9700 Thermalcycler
** hc2 HPV test performed with the Rapid Capture System
Source: HPV Comparison Study; Argent Global Services, 2010
HPV Comparison Study
Reduced time to results with minimal hands on time
480
420
360
300
cobas HPV test
240
hc2 HPV test
180
Cervista hrHPV test
120
60
0
# of Reportables
# of Reportables
Hands-On Time (min.)
Total Cycle Time (min.)
Walk-Away Time (% of Total)
Hands-On Time (min.)
Total Cycle Time (min.)
Walk-Away Time (% of
Total)
Includes daily
maintenance
cobas HPV test
hc2 HPV test
Cervista hrHPV test
94
33.17
299.71
90%
88
149.02
416.5
62%
48
129.01
476.64
66%
Source: HPV Comparison Study; Argent Global Services, 2010
cobas CT/NG v2.0 Test
Workflow
16
102
27
86
86
153
105
16
28
86
167
1 hr
2 hr
86
3 hr
4 hr
5 hr
cobas CT/NG v2.0 Test
Parallel Testing
1 hr
2 hr
3 hr
4 hr
5 hr
6 hr
25,000 tests / year
50,000 tests / year
1 hr
2 hr
3 hr
4 hr
5 hr
6 hr
7 hr
8 hr
cobas CT/NG v2.0 Test
Parallel testing flexibility with HPV
1 hr
1 hr
2 hr
2 hr
3 hr
3 hr
4 hr
4 hr
5 hr
5 hr
6 hr
6 hr
7 hr
7 hr
8 hr
8 hr
9 hr
10 hr
11 hr
CT/NG Assay Comparison Study
Minimal system maintenance, minimal hands on time
cobas 4800 Abbott m2000
CT/NG
CT/NG
# of Reportables
BD Viper
CT/NG
Hologic
Panther
Hologic
Tigris CT/NG
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 test
Least amount of hands on time
Includes daily maintenance
Abbott m2000
CT/NG
50.55
BD Viper
CT/NG
87.36
Hologic
Panther
Hands-On Time (min.)
cobas 4800
CT/NG
39.84
50.15
Hologic
Tigris CT/NG
88.6
Total Cycle Time (min.)
278.87
380.01
270.11
371.86
359.04
86%
81%
62%
87%
75%
Walk-Away Time (% of total)
Source: CT/NG Comparison Study; Argent Global Services, 2012

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