The cobas 4800 System Engineered for peace of mind - · PDF fileAdvanced technology served in...

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The cobas ® 4800 System Engineered for peace of mind

Transcript of The cobas 4800 System Engineered for peace of mind - · PDF fileAdvanced technology served in...

The cobas® 4800 SystemEngineered for peace of mind

Advanced technology served in a simpler form

The cobas® 4800 System features state-of-the-art, fully automated sample preparation combined with real-time polymerase chain reaction (PCR) technology for ampli-fication and detection, plus easy-to-use software that seamlessly integrates both components. This combination of elements provides true walk-away automation for maxi-mum lab efficiency.

Accuracy and reliability for peace of mind The accuracy and precision of the cobas® 4800 System allows faster processing for higher throughput using high-quality nucleic acid extract. Results are accurate and unambiguous. Robust engineering reduces maintenance needs and minimizes expected downtime.

O-Ring GrooveO-Ring

Stop

Pressure Sleeve Tip

Coupling Shoulder

Designed for reliability

Refined components produce superior results High-performance lysis and nucleic acid purification with magnetic bead technology requires efficient heating and mixing. The customized 96-well heater/shaker is designed to optimally fit to the bottom of the 96-well plate. The result is rapid and uniform heating of all samples.

Total aspirate and dispense monitoring A highly precise pressure monitoring system tracks all pipetting steps to ensure that reagents and samples are transferred accurately. By measuring air displacement with each tip, the system helps identify errors, enabling the user to take the appropriate corrective action.

Can pipetting be intelligent?The system’s unique CO-RE tip technology actively locks the pipette tips in place with an O-ring that expands to fit a specifically designed groove to improve sealing. This O-ring is decompressed during the tip release, providing a gentle release. This avoids any ballistic motions that could create aerosols of sample and reagents, which often contribute to cross-contamination.

Keeping contamination at bay The liquid-handling parameters of each reagent and sample type have been optimized and adjusted to accommodate viscosity, density, and volume needed. This minimizes the risk of contamination while ensuring reproducible results.

The total aspirate and dispense monitoring system uses a pressure sensor to record and monitor the pressure within the tips during every liquid handling step to detect low volumes and clogs. Any pressure response that falls outside of the expected range is reported as an error, and a digital trace log is produced with information about the sample affected. This allows the user to take the appro-priate corrective action.

O-Ring

O-Ring

O-Ring

O-Ring

Interference Fit

CO-RE Fit

Pipetting Channel

Pipetting Channel

Pipetting Channel

Pipetting Channel

Tip

Tip

Tip

Tip

Easy to learn, easy to use

Extends the workday but not the workload The cobas® 4800 System can continue to run after personnel have left for the day.

Automated PCR setup The cobas x 480 performs sample preparation and PCR setup in a single step without any user intervention.

The cobas® 4800 software - simply reliable Technicians find it easy to learn the cobas® 4800 System. The intuitive graphical user interface provides all instructions to operate the system. The system will direct the techni-cian to perform all necessary tasks, from the loading of the samples to the starting of a new run. This advanced software has been designed to detect loading errors and guide the user to the appropriate corrective action. For example, if a reagent is loaded in the wrong position, the system will prevent a run from being started until the reagent is moved to the proper position.

Bi-directional communication with your laboratory information system Test ordering has just become easier. Technicians simply insert barcoded primary vials into the system, and the software automatically queries your LIS to download test information.

cobas® 4800 System control

Laboratory Information System (LIS) cobas x 480

cobas z 480

Results you can depend on

Results integrity The proprietary AmpErase enzyme destroys virtually all previously generated amplicon, reducing the risk of cross-contamination. An internal control (IC) is used through the entire process, from sample preparation to amplifi-cation and detection, thereby minimizing the risk of false negatives.

Reproducibility The unique Therma-Base layer provides uniform heating and cooling across the entire plate to allow faster, more reproducible results.

Advanced technology in amplification and detection Real-time PCR is becoming the standard in molecular diagnostics due to the fast processing time, reliable results and wide dynamic range.

Faster amplification and detection The cobas z 480 is the most advanced edition of the highly regarded LightCycler® line. It was specifically developed for in vitro diagnostic (IVD) applications, offering faster amplification for higher throughput and superior fluorescence signal detection. The unique silver thermal block design provides temperature uniformity to ensure accurate amplification with every sample.

Temperature homogeneity across the plate:

a) LightCycler® 480 Instrument;

b) another real-time PCR instrument.

The melting temperature (Tm) of a given labeled oligonucle-otide was used to demonstrate temperature homogeneity across a multi-well plate (at 50°C). The variation between the measured Tm and the expected Tm of the oligonucle-otide was plotted for all wells, using the expected Tm as zero.

Advanced digital optics technology The sophisticated digital optical system and optimized focal length provide a direct read of the fluorescence signal with uniform data capture across the entire plate. Taking pictures of every plate digitally eliminates the noise related to film photography and ensures high precision of results.

A B

A C G A C

U

G C G AA

AmpEraseEnzyme

U

U

U

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913

-1

-0.5

0

0.5

1

Tm

1721 P

KF

A5

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913

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-0.5

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1721 P

KF

A

Designed for lab efficiency

Unambiguous results • Resultsareeitherpositive,negative,orinvalid—

reducing the need to retest

• Internalcontrolensurescompleteprocessmonitoring—including individual sample tracking from the beginning of the process until its end

• Automatedmonitoringandreportingofsystemperformance

Streamlined workflow • Nucleicacidextractionfrommultipletypesofspecimens

is fully automated, with the fewest manual steps:

•Swabandurinesamplesincobas PCR Media in a single run

•Multipleliquidcytologymediatypesinasinglerun • Nomanualpreprocessing

• cobas PCR Media tubes and liquid cytology vials can be loaded directly into the system

• Load-and-Goreagentsarealreadybar-codedand ready to use, requiring no additional mixing

• BidirectionalconnectivitytotheLISenablestheautomated reporting of results

• Samplepreparationtimeismatchedtothedetectionthroughput, making it easier for technicians to schedule their workday

The auto-loader scanner detects any barcoded labware placed in the system in either a horizontal or vertical orientation. It ensures that multiple kinds of labware can run together and watches for any user error that could, if undetected, invalidate a run.

Flexibility to meet different needs • Adaptstotheneedsandthroughputofeachlab—

can run up to 376 samples in a day but is still efficient for labs with less intensive testing needs

• cobas PCR Media collection tubes and liquid cytology vials can be loaded directly into the system

• Instrument sensitivity and assay design minimizes the sample input volume; therefore, multiple tests can be run from the same patient specimen

• TheAmplificationandDetectionOnlyworkflowallowslabs to run samples processed by other sample extraction solutions

Your input drives our innovation Roche Molecular Diagnostics: the legacy of PCR

Roche introduced PCR and is still perfecting it every day.

Noothercompanyhasmoreexperienceinmoleculardiagnostics.

One call gives you direct access to a world class support organization. Our technical support hotlines provide immediate access to local support teams backed by global experts.

OurGlobalSystemsSupportorganizationofmorethan2.000technical and field experts serves Roche customers in more than 70 countries.

This new system is the result of the active feedback from many lab professionals around the world. Roche has instituted ongoing programs to compile customers’ feedback to drive future product improvements.

Prototypes have been tested in several laboratories in different geographies to optimize the workflow and usability while ensuring that the highest performance expectations can be met.

“Without any doubt the cobas® 4800 System is the easiest molecular system I’ve ever worked with. After a minimal training I could complete my runs successfully. The software is a perfect guide during loading, a great help highlighting important issues of the run and informing me on each step in the procedure.”

“[C]omplete automation of DNA testing for HPV and CT/NG has a lot of advantages such as standardization, reproducibility, lack of contamination, less hands-on time. Roche’s fully automated cobas® 4800 System is very helpful and can be easily integrated in the work flow of laboratories that must perform a high number of routine tests.”

Linda Poort, Laboratory Technician

VU medisch centrum, Amsterdam, The Netherlands

Dr. Mateos Lindemann, Laboratory Director

Hospital Ramón y Cajal, Madrid, Spain

System specifications and technical details

Power supply

Power consumption ≤600 W

Voltage 110-120VAC

220-240VAC

Frequency 50/60 Hz ± 5%

Delayed-action fuse 115 VAC: 6.3 A

230VAC:3.15A

Power interruption ≤10 ms (for interruptions exceeding this limit, a UPS is recommended)

Interface

Instrument to PC USB

Dimensions

Instrument dimensions (with full cover)

Width: 1664 mm Height: 903 mm Depth: 1010 mm

Net weight ~150 kg

Power supply

Power consumption 1500 VA

Voltage 200-240VAC

Frequency 50/60 Hz

Dimensions

Instrument dimensions (with full cover)

Width: 574 mm Height: 497 mm Depth: 588 mm

Net weight ~55 kg

Environmental requirements

Temperatures allowed during operation 15°C to 32°C

Relative humidity allowed during operation Maximum: 80% at 32°C, no condensation Minimum: 30% at 15°C to 32°C

cobas x 480:

cobas z 480:

Contact a Roche Molecular Diagnostics representative in your market or visit http://molecular.roche.com

COBAS, LIFE NEEDS ANSWERS, AMPERASE and LIGHTCYCLER are trademarks of Roche. Excel is a trademark of Microsoft Corporation.

©2009 Roche Diagnostics Systems, Inc.

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