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

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Presentation on theme: "Cobas ® 4800 System Innovation that Simplifies page 1 © 2014 Roche."— Presentation transcript:

1 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

3 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

4 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 v2.1 1 HPV, CT/NG, HSV 1 BRAF, EGFR, PI3K 1, KRAS 1 MRSA 1 /MSSA 1, Cdiff 1 * 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

5 © 2014 Roche Plate Carrier Tip Carrier 1 Tip Carrier 2 Stationary Carrier Reagent Loading Area cobas x 480 Instrument Instrument Deck Overview Sample Loading Area

6 © 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 System Requires Minimal Maintenance No Monthly Maintenance

7 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 carrier holds up to 12 PreservCyt vials 24 sample carrier holds up to 24 PCR Media tubes or 24 Sarstedt tubes © 2014 Roche

8 Load samples 1.Uncap samples. 2.Place samples on corresponding carrier. 3.Insert sample carriers on autoload tray. 4.Click Load Samples. cobas x 480 Instrument Load Samples and Work Order File

9 cobas x 480 Instrument Designed for reliability DesignBenefit 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

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 O-ring Tip O-ring groove Piston O-ring in groove Tips locked in place by an O-ring that fits into a groove inside the neck of the tip © 2014 Roche

11 cobas x 480 Instrument Aspiration and Dispense Monitoring

12 Reagent Carriers cobas x 480 Instrument Instrument Deck Overview 200 ml Reagent Reservoir 50 ml Reagent Reservoir Assay Specific Reagents © 2014 Roche

13 cobas x 480 Instrument Stationary Carrier Heater / Shaker Magnetic Plate Home position for DWP Loading position for PCR Plate © 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 AD Plate holder Extracted specimen + Master Mix © 2014 Roche

15 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

17 © 2014 Roche cobas z 480 System High Performance Real-Time PCR DesignBenefit 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

18 cobas z 480 analyzer High Performance Real-Time PCR DesignBenefit 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

19 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 C t calculations Multivariable Algorithm Eliminate the guessing game

20 Expanding System Capabilities User Defined Workflow software DesignBenefit 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

21 cobas 4800 System Results Runs Test Results Accept Results Print Report

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 Source: Argent Global Services Walk Away Time

24 cobas ® HPV Test 96 HPV results with genotyping for 16& 18 in 5 hrs. no reflex testing required Source: Argent Global Services, HPV Samples 24 HPV Samples 1 hr2 hr3 hr4 hr5 hr6 hr7 hr 146 min.120 min.30 8 hr 83 min.120 min. 16

25 cobas HPV Test Parallel testing provides flexibility Source: Argent Global Services, HPV Samples 48 HPV Samples 72 HPV Samples 96 HPV Samples 1 hr2 hr3 hr4 hr5 hr6 hr7 hr8 hr9 hr10 hr 83 min120 min 16

26 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 hr2 hr3 hr4 hr5 hr6 hr7 hr 146 min.120 min.30 8 hr9 hr10 hr12 hr11 hr13 hr14 hr Source: Argent Global Services, 2012

27 HPV Comparison Study Least 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 testhc2 HPV testCervista hrHPV test # of Reportables Hands-On Time (min.) Hands-On Time (min.) without daily man=intenance Total Cycle Time (min.) without Daiuly Maintenance Total Cycle Time (min.) Walk-Away Time (min.) Walk-Away Time (% of Total)90%62%66% Daily Maintenance Time (min.)

28 HPV Comparison Study Reduced time to results with minimal hands on time Source: HPV Comparison Study; Argent Global Services, 2010 cobas HPV testhc2 HPV testCervista hrHPV test # of Reportables Hands-On Time (min.) Total Cycle Time (min.) Walk-Away Time (% of Total)90%62%66% Includes daily maintenance

29 cobas CT/NG v2.0 Test Workflow hr2 hr3 hr4 hr5 hr

30 cobas CT/NG v2.0 Test Parallel Testing 1 hr2 hr3 hr4 hr5 hr6 hr 1 hr2 hr3 hr4 hr5 hr6 hr7 hr 8 hr 25,000 tests / year 50,000 tests / year

31 cobas CT/NG v2.0 Test Parallel testing flexibility with HPV 1 hr2 hr3 hr4 hr5 hr6 hr7 hr8 hr9 hr 10 hr 11 hr 1 hr2 hr3 hr4 hr5 hr6 hr7 hr 8 hr

32 CT/NG Assay Comparison Study Minimal 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 Hologic Tigris CT/NG # of Reportables Hands-On Time (min.) Hands-On Time (min.) without Daily Maintenance Total Cycle Time (min.) Total Cycle Time (min.) without Daily Maintenance Walk-Away Time (% of total)86%81%62%87%75% Walk-Away Time (% of total) without Daily Maintenance 87%83%67%90%83%

33 Source: CT/NG Comparison Study; Argent Global Services, 2012 cobas CT/NG test Least amount of hands on time Includes daily maintenance cobas 4800 CT/NG Abbott m2000 CT/NG BD Viper CT/NG Hologic Panther Hologic Tigris CT/NG Hands-On Time (min.) Total Cycle Time (min.) Walk-Away Time (% of total)86%81%62% 87% 75%


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