1. Innovation that Simplifies
cobas® 4800 System
Innovation that Simplifies
page 1 © 2014 Roche

2. 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
The cobas 4800 system has an innovative design, but is simple to use
Maximize efficiency with minimal hands-on time meeting the throughput requirements of screening tests
Minimal maintenance; only 2 -7 minutes of maintenance every 24 hrs., bleach is never used on this system. Carriers do not require bleaching between runs.
Air displacement system eliminates the need for large batches of wash buffer, system priming, and the disposal of large volumes of liquid waste.
Solid throughput;
94 hrHPV tests with genotyping of types 16 and 18 in approximately 5 hrs.
94 CT and 94 NG tests in under 5 hrs.
System consolidation; cobas® HPV test performed on the same system
IT Solutions; bi-directional LIS interface with host query and remote diagnostics

3. cobas 4800 System cobas x 480 instrument
66 inches
23 inches
cobas z 480 analyzer
Real-Time PCR
Based on LightCycler® technology
96 well plate format
4 channel detection
The cobas 4800 system is comprised of two instruments.
The cobas x 480 instrument for automated specimen preparation and PCR set up and the cobas x 480 analyzer is a real-time PCR system for amplification and detection based on LightCycler® technology.
These instruments are linked via the cobas 4800 system software. The Roche Diagnostics cobas 4800 software runs on a dedicated control unit. A handheld barcode scanner is connected to the control unit. It is used to scan reagent and reagent reservoir barcodes during loading of reagents, as well as sample barcodes to setup the work order file.
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
© 2014 Roche

4. 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
CT / NG
BRAF
EGFR
EGFR RUO*
PI3K RUO*
KRAS RUO*
HPV, CT/NG, HSV1
BRAF, EGFR,
PI3K1, KRAS1
MRSA1/MSSA1, Cdiff1
The cobas CT/NG v2.0 test helps optimize profitability by enabling your lab to run multiple tests on the same system.
(Review the tests listed above, pointing out that some are RUO and some are not yet available in the U.S.)
One system…many tests…which means your lab won’t need to make capital investments in multiple instruments, which is always good for the bottom line.
* 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

5. cobas x 480 Instrument Instrument Deck Overview
Plate
Carrier
Tip Carrier 2
Stationary
Carrier
Tip Carrier 1
Sample
Loading
Area
Reagent
Loading
Area
Plate Carrier
This is the home of the deepwell plate (extraction plate) and the amplification / detection (AD) plate.
Tip Carrier
The tip carrier holds 5 trays of 96 tips each.
Sample Loading Area
The sample loading area can hold up to 94 swab and urine tubes, 94 Sarstedt tubes, and 94 PreservCyt® (ThinPrep) vials.
Note: the PreservCyt vial feature will not be available at launch.
Stationary Carrier
The stationary carrier is where the specimen preparation takes place and the processed specimen is added to the master mix, for the real-time PCR amplification and detection phase.
Reagent Loading Area
Reagent are transferred to reagent reservoirs and placed on the system.
© 2014 Roche 5

6. 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
Performed bi-annually by Roche Field Service
The cobas 4800 system software provides a graphical interface for the operator. The software features a wizard that will guide the operator through the tasks that need to be performed.
This is the system overview screen of the cobas 4800 system software. System and maintenance status at a glance, changes in color will also indicate status. If maintenance is required, the system will not operate.
© 2014 Roche

7. cobas x 480 Instrument Positive patient ID
Sample Carriers
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.
24 sample carrier holds up to 24 PCR Media tubes or 24 Sarstedt tubes
The specimen loading area holds up to 94 patient samples. Controls are loaded on the specific reagent rack, which will be covered shortly.
As the specimens are loaded onto the system, the onboard barcode scanner reads the barcode and the specimen is connected to the pending test order. There is no need to load specimens in a specific order.
The cobas 4800 system software uses host query to match specimens with orders that have been downloaded from the LIS or from the Work Order Editor program. This linkage between the specimen and the order also provides positive specimen identification throughout the testing process.
12 sample carrier
holds up to 12 PreservCyt vials
© 2014 Roche

8. cobas x 480 Instrument Load Samples and Work Order File
Uncap samples.
Place samples on corresponding carrier.
Insert sample carriers on autoload tray.
Click Load Samples.
The first step in beginning a run is to load the specimens.
The operator must first down load orders from the LIS or prepare orders with the work order editor.
The intuitive cobas 4800 system software will walk the operator thru the process of loading the specimen carriers.
As the racks are loaded into the deck the barcode reader will match the specimen number to the work order number providing positive patient identification. Specimens do not need to be loaded in any particular order.
© 2014 Roche

9. cobas x 480 Instrument Designed for reliability
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
Pipetting is a very important part of the preparation step, and the system employed on the cobas x 480 instrument is a highly innovative one that contributes significantly to the overall reliability of the cobas 4800 system. The cobas x 480 instrument uses an air displacement pipetting system built on the Hamilton liquid handling systems, which are known for their reliability in fluid handling. Roche has used Hamilton systems for over 10 years in the blood screening arena.
As you can see these features not only contribute to the overall reliability, the design of these features plays a large role in the reduced risk for contamination.
Lets take a closer look at CO-RE tip technology.
© 2014 Roche

10. 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
Compression Induced O-Ring Expansion, or CO-RE tip technology locks the pipette tips in place with an o-ring that expands to fit a specifically designed groove in the neck of the tips to improve sealing. When the tip is released the o-ring is disengaged resulting in a gentle release of the tip which reduces aerosol formation.
In addition, this system enables tips to be connected without mechanical force, which over time improves the reliability of the system.
O-ring
O-ring in groove
Tip
O-ring groove
© 2014 Roche

11. cobas x 480 Instrument Aspiration and Dispense Monitoring
The air displacement pipetting comes with total aspirate and dispense monitoring (TADM), a software application that performs sample tracking to verify the sample transfer with a digital audit trail, by measuring the pressure responses for each pipetting step and comparing them to the expected pressure response curve. This verifies that proper sample volumes are transferred and reagents are added according to the protocol selected.
TADM detects pipetting errors during the aspiration step in real time, and uses liquid class optimization for all reagents and sample types to differentiate the viscosity of the different liquids used in the system. The cobas x 480 instrument also provides anti-droplet control by reducing droplet production from evaporative expansion of the tip. This is an important feature that reduces a potential source of contamination.
© 2014 Roche

12. cobas x 480 Instrument Instrument Deck Overview
Reagent Carriers
Assay Specific Reagents
The reagent carriers hold specific and generic reagents for batches of 24 or 96 tests. The 50 mL. and 200 mL. reservoirs will hold the generic reagents used for all assays. No reagent preparation is required with the cobas 4800 system.
Assay-specific reagents such as master mix, magnesium and controls are ready-to-use and provided in barcoded vials that can be placed directly on the system. 
Scan-Scan-Pour-Place Principle
To minimize handling errors the reagent reservoirs are filled and placed using the scan-scan-pour-place principle. First the operator scans the barcode of the required reagent using the handheld barcode scanner. Then, the operator scans the barcode of an unused reagent reservoir, using the handheld barcode scanner again. The reagent is poured into the scanned reagent reservoir, and the filled and scanned reagent reservoir is placed onto the required position of the reagent reservoir carrier as indicated in the cobas 4800 system software wizard.
50 ml Reagent Reservoir
200 ml Reagent Reservoir
© 2014 Roche

13. cobas x 480 Instrument Stationary Carrier
Heater / Shaker
Magnetic Plate
Home position for DWP
Loading position for
PCR Plate
The stationary carrier is the area where the samples are processed. It is mounted on the instrument deck and is not removable.
The stationary carrier holds four units: the heater/shaker unit, the magnetic plate, the deepwell plate holder, and the AD plate holder. The procedure for sample preparation includes: 1) media-specific processing, 2) generic binding, washing, and elution, and 3) working master mix preparation and PCR setup. The deepwell plate and AD plate are moved from the plate carrier to the stationary carrier while isolation takes place.
© 2014 Roche

14. 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
The deepwell plate and AD plate are moved from the plate carrier to the stationary carrier while isolation takes place.
The appropriate reagents, samples and controls are pipetted into wells in the deepwell plate.
The deepwell plate is moved to the heater/shaker unit where the sample is lysed and nucleic acids released. The Magnetic Glass Particle reagent is added, and the nucleic acids bind to the particles.
The deepwell plate is then moved to the magnetic plate for two washing steps. The magnets in the magnetic plate hold the magnetic glass particles in place so that the nucleic acids are not washed away. After washing, the elution buffer reagent is added which causes the nucleic acids to be released from the particles.
Following sample processing the master mix and processed specimen are added to the AD plate. Once complete, the deepwell plate with residual processed specimen and the AD plate with processed specimen and master mix are returned to the plate carrier.
AD Plate holder
Extracted specimen + Master Mix
© 2014 Roche 14

15. When sample preparation is complete the system instructs the operator to remove the completed AD plate, seal the plate and transfer it to the cobas z 480 analyzer. The barcode on the side of the AD plate assures that positive ID is maintained when the plate is loaded into the cobas z 480 analyzer.
The cobas z 480 analyzer performs real-time PCR amplification and detection, using LightCyler® technology for detection.
Simultaneous detection on five detection channels allows analysis of signals from multiple dyes in multiplex real-time PCR assays. As a benefit of this, multiple results can be reported from a single reaction.
cobas z 480 Analyzer
© 2014 Roche

16. 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
When sample preparation is complete the system instructs the operator to remove the completed AD plate, seal the plate and transfer it to the cobas z 480 analyzer. The barcode on the side of the AD plate assures that positive ID is maintained when the plate is loaded into the cobas z 480 analyzer.
© 2014 Roche

17. 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
The thermal block on the cobas z 480 analyzer is designed with a unique fluid filled therma-based layer.
This provides the ability to have shorter cycle times, and improved temperature homogeneity from well to well resulting in improved assay accuracy.
© 2014 Roche 17

18. cobas z 480 analyzer High 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
The cobas z 480 Analyzer has been designed with very few moving parts which contributes to the reliability of the system. There are 5 optical channels used to measure multiple targets in one reaction.
Advanced Digital Optics Design
© 2014 Roche

19. 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
Instrument-level processing – Each cobas z 480 analyzer is uniquely calibrated to account for system to system variability.
The filter wavelength were optimized to minimize spectral crosstalk between the different filters.
Scale invariant simply means that the algorithm is not dependent on big an optical signal is achieved - it's based on relative fluorescence increase and not some absolute signal increase.
Ct calculations are not based on a simple crossing of a threshold value (which can be very arbitrary).  Other methods use simple algorithms such as second derivative peaks to call a Ct value. With other systems, a technician is required to view curves of ambiguous results. The multivariable algorithm used in the cobas 4800 system accounts for a variety of signal artifacts such as late peaks, double humps and slow growth rates to produce results that are positive or negative with no grey zone.

20. 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
The cobas z 480 Analyzer will offer the flexibility for you to design your own assays. The system contains a software for user defined workflow used for user to defined applications.
When starting up the system the operator chooses to enter into the IVD software for HPV and CT/NG testing or the User Defined Workflow for laboratory developed tests.
© 2014 Roche

21. cobas 4800 System Results Test Results Runs Print Report
This is a view of the results screen of the cobas 4800 system software.
Runs: This is the list of completed runs. To review result the operator selects a run. Runs are labeled as the work orders are prepared.
Results: These results are for the cobas HPV Test with genotypes 16 & 18 identified. The last 2 valid result are for the controls and are identified by their lot number.
Result are reviewed, accepted and the run is complete.
During the time studies the first batch of 96 HPV samples were complete in under 5 hrs.
Accept Results
© 2014 Roche

22. cobas® 4800 System Workflow
© 2014 Roche

23. cobas 4800 system Process Map for 96 samples Requires minimal hands on time; frees staff to perform other tasks in the laboratory
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 Preparation
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
102 – 167
86 – 120
~8 min
Walk Away Time
These are the steps performed during a run on the cobas 4800 system.
Daily Maintenance – The cobas 4800 system requires minimal steps for daily maintenance which consist of examining the deck and cleaning any spills that may be on the deck, emptying the liquid waste, and emptying the tip waste if necessary. This step typically takes 2 – 7 minutes.
Load cobas x 480 – Loading of consumables, specimens, and reagents; everything required for the run including the work order. This step can take 16 – 30 minutes depending on the size of the batch; 24 tests vs 96 tests.
Sample Preparation – Automated total nucleic acid extraction and isolation by the cobas x 480 instrument. This includes the making of the master mix and pipetting of processed specimen into the AD plate for Real-Time PCR. This is an automated step that enables the operator to walk away from the system and perform other tasks. The processing time will vary dependent on the specimen type as well as the batch size. Sample processing for a 24 test batch of swabs and urine specimens for CT/NG testing takes 102 minutes and a batch of 96 samples will take approximately 167 minutes.
Unloading of the cobas x 480 analyzer takes approximately 5 – 8 minutes and takes place in parallel with the start up of the cobas z 480 analyzer.
Transfer to cobas z 480 – At the completion of sample processing the operator places a seal on the completed AD plate and transfers the plate to the cobas z 480 analyzer. Typically sealing the plate and loading the plate in the cobas z 480 analyzer will take 1 – 2 minutes.
Amplification and detection is another walkaway step where the operator is free to perform other tasks in the laboratory. Amplification and detection is always the same regardless of batch size or specimen type; 86 minutes for CT/NG and 120 minutes for HPV.
When the run is complete the operator removes the plate from the cobas z 480 analyzer and disposes of the plate. Typically this clean up step takes about 1 minute.
Source: Argent Global Services

24. Source: Argent Global Services, 2012
cobas® HPV Test
96 HPV results with genotyping for 16& 18 in 5 hrs.
no reflex testing required
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. 16
This slide displays run sizes of 96 & 24 PreservCyt media. Each run includes 1 positive control, and 1 negative control.
Steps
24 Samples (min.)
96 Samples (min.)
Daily Maintenance
3.9
Loading the cobas x 480 instrument 16 30
Specimen preparation time
102
167
Transfer to the cobas z 480 1
Amplification and detection
120
Unloading the cobas x 480* 5 8
Source: Argent Global Services, 2012
*This time is shown at the beginning of the second run and must be completed to start the next run of samples on the cobas x 480 instrument.

25. Source: Argent Global Services, 2012
cobas HPV Test
Parallel testing provides flexibility
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 min 16
This slide demonstrates multiple runs of 24 samples (22 patient specimens, 1 positive control, and 1 negative control) of PreservCyt media for HPV testing performed in parallel.
The first run of 24 samples are completed in just under 4 hrs; 22 patient results with one positive and one negative control.
Once specimen preparation is complete and the plate has been loaded in the cobas z 480 analyzer the operator is able to begin another sample preparation on the cobas x 480 instrument.
Following specimen preparation the operator must unload the cobas x 480 instrument. This unloading takes about 5 minutes, then the operator is able to begin loading the next run. The cobas x 480 instrument only requires daily maintenance every 24 hrs., so no maintenance or cleaning is required between runs. The internal clock on the cobas x 480 instrument will track the time for maintenance and can be seen on the status screen of the system software.
Source: Argent Global Services, 2012

26. Source: Argent Global Services, 2012
96 fully automated HPV with types 16 & 18 in 5 hours
High 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
Here we have multiple runs of 96 samples (94 patient specimens, 1 positive control, and 1 negative control) of PreservCyt media for HPV testing.
The first set of 96 results are completed in just under 5 hrs; 94 results with one positive and one negative control. Once the first run is complete an additional run is compete in approximately every 3 hrs.
The lab can complete 2 runs of 96 samples in right about 8 hours. Laboratories also have the option to place the Amp and detect plate in the cobas z 480 analyzer and leave for the evening and retrieve their results the next day.
Source: Argent Global Services, 2012

27. Source: HPV Comparison Study; Argent Global Services, 2010
Least amount of hands on time
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
EFFICIENCY GAINS!
The cobas HPV Test was compared to the hc2 test with the Rapid Capture system and the Cervista® HPV Test and the Tecan DNA Extractor with the ABI 9700 Thermalcycler.
# of reportables: Note the difference between the assays. The hc2 test requires 8 controls and calibrators reducing the number of results to 88 per 96 well plate. The Cervista assay uses 3 wells per sample reducing the throughput to 27 samples per plate, in this run 2 plates of samples were performed.
Total cycle time: The cycle for the cobas HPV Test is about 27% faster than the other tests.
Hands on Time: The cobas HPV Test provides full automation of sample preparation with real time PCR requiring 80% less user interventions
The next slide shows a graphical illustration of this comparison.
*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

28. Source: HPV Comparison Study; Argent Global Services, 2010
Reduced time to results with minimal hands on time
Includes daily
maintenance
You can clearly see the improved efficiency of the cobas HPV Test.
Walk away time: People often talk about the amount of walk away time and the ability to free staff up to perform other duties in the laboratory. It is just as important to compare cycle time with walk away time. Longer the cycle time can create longer walk away time. Sounds good, but that means the time to result is longer as well.
This slide demonstrates the importance of comparing all aspects of testing.
The cobas HPV Test combined with the cobas 4800 system automation provides efficiency in total cycle time which will impact your time to results. This system has the shortest cycle time with the least amount of hands on time allowing for the operator to be free; attending to critical lab functions 90% of the time.
cobas HPV test
hc2 HPV test
Cervista hrHPV test
# of Reportables 94 88 48
Hands-On Time (min.)
33.17
149.02
129.01
Total Cycle Time (min.)
299.71
416.5
476.64
Walk-Away Time (% of Total)
90%
62%
66%
Source: HPV Comparison Study; Argent Global Services, 2010

29. cobas CT/NG v2.0 Test Workflow16 27
153 86
102
105 28
167
1 hr
2 hr
3 hr
4 hr
5 hr
There are 4 options when testing for CT/NG. Testing is performed in runs of up to 24 or 96 samples (94 patient specimens with 1 positive and 1 negative control).
Swab and Urine specimens are performed together in one run, PreservCyt specimens are testing in a separate workflow.
Additional run sizes of 48 and 72 will provide improved efficiency for this higher volume test

30. cobas CT/NG v2.0 Test Parallel Testing
1 hr
2 hr
3 hr
4 hr
5 hr
6 hr
25,000 tests / year
Both runs of swab and urine specimens can be completed in an 8hr shift.
The first run of 24 samples is completed in approximately 3.5 hrs. with the second run following in about 2 hours.
Runs of 96 samples take a bit longer with the first run completed in about 4.5 hrs.
50,000 tests / year
1 hr
2 hr
3 hr
4 hr
5 hr
6 hr
7 hr
8 hr

31. cobas CT/NG v2.0 Test Parallel 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
For the best efficiency HPV testing should be started first (HPV has the longest Amp & Det time) followed by CT/NG testing.
The flexibility of the cobas 4800 system allows the operator to intermix runs of 24 or 96 samples based on the laboratories specimen volume.

32. Source: CT/NG Comparison Study; Argent Global Services, 2012
CT/NG Assay Comparison Study Minimal system maintenance, minimal hands on time
cobas 4800 CT/NG
Abbott m2000 CT/NG
BD Viper CT/NG
Hologic Panther
Hologic
Tigris CT/NG
# of Reportables 94 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
83%
67%
90%
This chart is a comparison of five systems that are used by laboratories today comparing runs of 96 samples. This data set was recorded during the cobas CT/NG test clinical study.
Least amount of hands on time for the cobas CT/NG test.
Note the difference in hands on time when maintenance is taken away for the m2000, BD Viper system, Panther, and the Tigris. That difference is the time it takes to perform daily maintenance.
Weekly maintenance for the cobas 4800 system only takes approximately 7 minutes which includes daily maintenance.
No monthly maintenance is required for the cobas 4800 system.
The next slide contains the graphical representation for this data for total testing time, including maintenance.
Source: CT/NG Comparison Study; Argent Global Services, 2012

33. Source: CT/NG Comparison Study; Argent Global Services, 2012
cobas CT/NG test
Least amount of hands on time
Includes daily maintenance
The cobas CT/NG test has the least amount of hands on time and cycle time for runs of 96 samples.
It is important to compare hands on time and cycle time. Many will claim long walk away time, however they enjoy the long walk away time due long cycle time to result.
cobas 4800 CT/NG
Abbott m2000 CT/NG
BD Viper CT/NG
Hologic Panther
Hologic
Tigris 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%
Source: CT/NG Comparison Study; Argent Global Services, 2012