Easy begins here.COBAS® Portfolio of Real-Time PCR Systems

Easy-to-operate systems provide walk-away technology that delivers reliable results.

Easy begins with… COBAS® Portfolio of Real-Time PCR Systems

* The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is not available in the United States.

Walk-away technology that delivers reliable results

• Automated primary tube handling

• Ready-to-use bar-coded reagent cassettes minimize manual preparation and errors

• Single-room operation consolidates routine testing

• Modular/flexible system optimizes space and workflow

• Contamination controls ensure sample and data integrity

Advanced test performance

• Refined primer/probe chemistry improves specificity, sensitivity, and dynamic ranges

• Enhanced genotype/subtype inclusivity improves patient management

Start-to-finish capabilities

• Largest PCR manufacturing facility from research to in-house manufacturing

Locally-based field service offers excellent customer and product support

• 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

Roche is the global leader in molecular diagnostics and has developed the only real-time PCR system that unites primary tube handling with fully automated sample preparation, amplification and detection of RNA or DNA. The easy-to-operate system provides high throughput processing for a menu of important molecular tests including HIV, HCV, HBV, and CMV*. The system improves workflow efficiencies in your laboratory and reduces hands-on time.

Global Systems Support

Our Global Systems

Support organization of

more than 2,000 technical

and field experts serves

Roche customers in more

than 70 countries.

The fully automated solution For simplified, molecular testing

The only fully automated, real-time PCR system that unites primary tube handling and sample preparation with amplification, quantification and detection of RNA or DNA.

Easy begins with… cobas p 630 Instrument/COBAS® AmpliPrep/COBAS® TaqMan® System

Important advantages of the Roche integrated sample processing and detection system

• High throughput capacity: Run a total of 168 samples within an 8 hour shift or overnight with the docked system for continuous operation

• Task flexibility: 4 independent, onboard thermal cyclers allow up to 4 assays to run simultaneously

• Advanced assay performance: Excellent sensitivity, specificity, and broad linear range to minimize the need for repeat testing or dilutions

• Integrity of results: AmpErase enzyme and a closed-tube format optimizes contamination control

• Quantitation standards and internal controls are used throughout the entire process, from sample preparation to amplification, quantification and detection, to deliver reliable and accurate results

• Dependable self-monitoring operation: Clot detection and input-volume-surveillance ensure dependable results

• Ready-to-use reagents with self-sealing caps and bar-coded sample tracking ensure reagent consistency and simplifies workflow

cobas p 630 Instrument

• Complements the system: Automates pre-analytics and real-time PCR diagnostic testing for a menu of important molecular tests

Unique docking station streamlines workflow, maximizes productivity

• Prepared samples transfer automatically from the COBAS® AmpliPrep Instrument to the COBAS® TaqMan® Analyzer

• Enables continuous operation with no manual sample transfer

This automated system increases laboratory capability and productivity from sample preparation to real-time amplification, quantification and detection. The easy-to-operate system delivers reliable test results and reduces overall costs.

Easy begins with…COBAS® AmpliPrep/COBAS® TaqMan® 48 System

Simple to use, easy to integrate

• Fast results: Two independent thermocylers allows detection/amplification of DNA or RNA for up to 2 assays simultaneously

• Flexible lab productivity: Two independent thermal cyclers provide 48-sample capacity

• Advanced assay performance: Real-time PCR technology provides broad dynamic ranges, excellent sensitivity and specificity

• Enhances workflow: No user interaction required after prepared samples are loaded. The system provides PCR set-up and no post-PCR manipulations

• Reduces contamination risk: Closed-tube format and AmpErase enzyme reduce cross-reactivity and minimize testing errors

This semi-automated, closed-tube system makes molecular testing practical for everyday lab use. The system incorporates the COBAS® TaqMan® 48 Analyzer, which has a compact footprint.

Easy begins with…The High Pure System Viral Nucleic Acid Kit

The High Pure System Viral Nucleic Acid Kit

• Designed: Purification of viral nucleic acids from EDTA plasma or serum

• Purification procedure: Filler tubes allow for multiple samples to be processed in parallel

• Specimen input: 500 uL of EDTA plasma or serum

• Kit size: 48 sample preparation

• Sample preparation for TaqMan® 48 Analyzer: Each single sample preparation can be used with the COBAS® TaqMan® HIV, HCV, and HBV Tests

• Closed-tube processing and built-in Roche AmpErase enzyme

The High Pure System Viral Nucleic Acid Kit along with the COBAS TaqMan® 48 Analyzer empowers laboratories to provide physicians and their patients access to the convenience of real-time PCR with the innovation you expect from Roche.

Laboratories can select among the portfolio the configuration that is suitable for their individual workflow and throughput needs.

Easy begins with…Configuration flexibility and customizable solutions

Result integrity and data security

• Sample tracking from start-to-finish reduces errors and saves time

• Automatic archiving and backup of data

Flexibility and simplicity

• Offers the flexibility of integrated sample processing and detection systems with multiple system manage-ment, including system maintenance and sample and reagent level

• Reagent lot tracking allowing kits to be used for multiple runs

• Easy-to-use graphical user interface

• Easy-to-read display of system and sample status

• Customized reports

• Software guides through maintenance procedures

Connectivity

• Capability for bidirectional interfacing to laboratory information systems

• cobas p 630 Instrument can link to and support up to three COBAS® AmpliPrep Instruments

• One COBAS® AmpliPrep Instrument supports any combination of three COBAS® TaqMan® Analyzers or COBAS® TaqMan® 48 Analyzers

AMPLILINK Software user interface is a Windows®-based application that manages operation and maintenance of the complete system. AMPLILINK Software is designed to deliver maximum flexibility, efficiency and integrity to your lab’s workflow – from sample input through results output.

AMPLILINK 3.3 Client

Laboratory Info System (LIS)

COBAS® TaqMan® 48

Analyzer

COBAS®

TaqMan®

Analyzer

COBAS® AmpliPrep Instrument (up to 3)

AMPLILINK 3.3 Server

cobas p 630 Data Station

AMPLILINK 3.3 Client

cobas p 630 Instrument

Global Surveillance Program for better diagnostics, prognostics, and disease management

• Integral part of Roche Molecular Diagnostics’ product development: including research and development, regulatory submission, and post-launch support*

• Input from the program has improved the design and development of products

• Roche continues to broaden its own database: currently expanding sample acquisition in Europe, South America, Africa and Asia†

• Facilitates epidemiological investigations: helps to identify trends responsible for the spread of infection, builds on current collaborations and the pursuit of new ones

* These products are not available in all countries. Please contact the Roche Diagnostics representative in your country.† Young KKY, Roche Viral Surveillance Program. Data on files, Roche Molecular Diagnostics.

Roche’s Global Surveillance Program is designed to make a positive, lasting impression on the field of molecular diagnostics in many ways. Roche’s Global Surveillance Program monitors viral sequence changes and supports continuous improvement of PCR assays.

† Available in the United States as research use only.§ These products are not available in all countries.

Please contact the Roche Diagnostics representative in your country.

Product Catalog Number

COBAS® TaqMan® 48 Analyzer 03279332001

COBAS® TaqMan® Analyzer 03121453001

COBAS® AmpliPrep Docking Station 28127387001

COBAS® AmpliPrep Instrument 03051315001

cobas p 630 Instrument 05527503001

COBAS® AmpliPrep/COBAS® TaqMan® HBV Test (CE-IVD) 03587819190

COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0 (CE-IVD) 04894570190

COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0 (FDA-IVD) 05027012190

COBAS® AmpliPrep/COBAS® TaqMan® HIV Qual† RUO 05035724190

COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test§ (FDA-IVD) 03542998190

COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 (CE-IVD) 05212294190

COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 (FDA-IVD) 05212308190

COBAS® AmpliPrep/COBAS® TaqMan® HCV Test (CE-IVD) 03568547190

COBAS® AmpliPrep/COBAS® TaqMan® HCV Test (FDA-IVD) 03568555190

COBAS® AmpliPrep/COBAS® TaqMan® CMV Test (CE-IVD) 04902068190

COBAS® TaqMan® HIV-1 Test, v2. For use with the High Pure System† (CE-IVD) 05923468190

COBAS® TaqMan® HBV Test For use with the High Pure System (CE-IVD) 03500756190

COBAS® TaqMan® HBV Test For use with the High Pure System§ (FDA-IVD) 03577163190

COBAS® TaqMan® HCV Test, v2.0 For use with the High Pure System (CE-IVD) 04861817190

COBAS® TaqMan® HCV Test, v2.0 For use with the High Pure System (FDA-IVD) 05989060190

COBAS® TaqMan® MTB Test§ (CE-IVD) 04803531190

COBAS® TaqMan® CT Test, v2.0† (CE-IVD) 05055202190

Instrument and Test Ordering InformationFor more information about Roche Diagnostics products, please contact the Roche Diagnostics representative in your country.

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