2cobas 4800 System Innovation made Simple Minimal System MaintenanceDaily / Weekly maintenance requires ~ 2 – 7 minutesNo bleaching of the system or componentsNo Monthly maintenanceAutomated Specimen PreparationDesigned for pipetting directly from primary or secondary vial for specimens with reduced volume, Secondary vial requires only 1 mL of volumeOn board bar-code scanner for positive patient identificationReagents are ready to useAir displacement system, no system fluids or priming cyclesInnovative System DesignCO-RE Tips designed to reduce aerosols that can cause contaminationTADM to ensure accurate sample and reagent pipettingLightCycler® Technology used for many years with the LightCycler® instrumentThe cobas 4800 system has an innovative design, but is simple to useMaximize efficiency with minimal hands-on time meeting the throughput requirements of screening testsMinimal 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 systemIT Solutions; bi-directional LIS interface with host query and remote diagnostics
19Multivariable Algorithm Eliminate the guessing game Instrument-level processing corrects for optical system variabilityFilter design and manufacturing process minimized spectral cross-talkPrimary data reduction algorithm is fluorescence scale invariantNo more simplistic threshold methods for Ct calculationsInstrument-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.
23cobas 4800 system Process Map for 96 samples Requires minimal hands on time; frees staff to perform other tasks in the laboratoryMaintenanceDaily / WeeklyNo MonthlyBleach is never used on the cobas 4800 systemLoadSamples in primary or secondary vialsConsumablesReagents, no preparation requiredSample PreparationDirectly from primary vial or secondary vialPCR ready plate is transferred to cobas z 480 Analyzer (1 min)Real-Time PCRMultiplex Real-time PCR with multiple targets in one reactionEnd of run clean upDispose of extraction plateDispose of reagent reservoirs and tubesDispose of AD plate2 – 7min16 – 30102 – 16786 – 120~8 minWalk Away TimeThese 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
24Source: Argent Global Services, 2012 cobas® HPV Test96 HPV results with genotyping for 16& 18 in 5 hrs.no reflex testing required96 HPV Samples24 HPV Samples1 hr2 hr3 hr4 hr5 hr6 hr7 hr146 min.120 min.308 hr83 min.16This slide displays run sizes of 96 & 24 PreservCyt media. Each run includes 1 positive control, and 1 negative control.Steps24 Samples (min.)96 Samples (min.)Daily Maintenance3.9Loading the cobas x 480 instrument1630Specimen preparation time102167Transfer to the cobas z 4801Amplification and detection120Unloading the cobas x 480*58Source: 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.
25Source: Argent Global Services, 2012 cobas HPV TestParallel testing provides flexibility24 HPV Samples48 HPV Samples72 HPV Samples96 HPV Samples1 hr2 hr3 hr4 hr5 hr6 hr7 hr8 hr9 hr10 hr83 min120 min16This 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
26Source: Argent Global Services, 2012 96 fully automated HPV with types 16 & 18 in 5 hoursHigh volume throughput – 288 results in under 12 hrs96 HPV Samples192 HPV Samples288 HPV Samples384 HPV Samples1 hr2 hr3 hr4 hr5 hr6 hr7 hr146 min.120 min.308 hr9 hr10 hr12 hr11 hr13 hr14 hrHere 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
27Source: HPV Comparison Study; Argent Global Services, 2010 Least amount of hands on timecobas HPV testhc2 HPV testCervista hrHPV test# of Reportables948848Hands-On Time (min.)33.17149.02129.01Hands-On Time (min.) without daily man=intenance29.3142.71125.84Total Cycle Time (min.) without Daiuly Maintenance295.84404.64471.43Total Cycle Time (min.)299.71416.5476.64Walk-Away Time (min.)266.55248.97309.19Walk-Away Time (% of Total)90%62%66%Daily Maintenance Time (min.)3.8711.865.21EFFICIENCY 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 interventionsThe 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 SystemSource: HPV Comparison Study; Argent Global Services, 2010
28Source: HPV Comparison Study; Argent Global Services, 2010 Reduced time to results with minimal hands on timeIncludes dailymaintenanceYou 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 testhc2 HPV testCervista hrHPV test# of Reportables948848Hands-On Time (min.)33.17149.02129.01Total Cycle Time (min.)299.71416.5476.64Walk-Away Time (% of Total)90%62%66%Source: HPV Comparison Study; Argent Global Services, 2010
29cobas CT/NG v2.0 Test Workflow 162715386102105281671 hr2 hr3 hr4 hr5 hrThere 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
30cobas CT/NG v2.0 Test Parallel Testing 1 hr2 hr3 hr4 hr5 hr6 hr25,000 tests / yearBoth 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 / year1 hr2 hr3 hr4 hr5 hr6 hr7 hr8 hr
31cobas CT/NG v2.0 Test Parallel testing flexibility with HPV 1 hr2 hr3 hr4 hr5 hr6 hr7 hr8 hr9 hr10 hr11 hrFor 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.
32Source: CT/NG Comparison Study; Argent Global Services, 2012 CT/NG Assay Comparison Study Minimal system maintenance, minimal hands on timecobas 4800 CT/NGAbbott m2000 CT/NGBD Viper CT/NGHologic PantherHologicTigris CT/NG# of Reportables94929896Hands-On Time (min.)39.8450.5587.3650.1588.6Hands-On Time (min.) without Daily Maintenance35.9939.4566.4836.2153.76Total Cycle Time (min.)278.87380.01270.11371.86359.04Total Cycle Time (min.) without Daily Maintenance275.02368.91249.23357.92321.11Walk-Away Time (% of total)86%81%62%87%75%Walk-Away Time (% of total) without Daily Maintenance83%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
33Source: CT/NG Comparison Study; Argent Global Services, 2012 cobas CT/NG testLeast amount of hands on timeIncludes daily maintenanceThe 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/NGAbbott m2000 CT/NGBD Viper CT/NGHologic PantherHologicTigris CT/NGHands-On Time (min.)39.8450.5587.3650.1588.6Total Cycle Time (min.)278.87380.01270.11371.86359.04Walk-Away Time (% of total)86%81%62%87%75%Source: CT/NG Comparison Study; Argent Global Services, 2012