For in vitro diagnostic use. System cobas pure integrated solutions IVD cobas® pure integrated solutions SYS_351 09 031 537 001 9 031 537 001 09031537001 9031537001 09031537001 cobas pure sample supply unit cobas® pure sample supply unit 07613336226964 Instruments Not Available Not Available 09 031 553 001 9 031 553 001 09031553001 9031553001 09031553001 cobas pure e 402 analytical unit cobas e 402 07613336226988 Instruments Not Available Not Available 09 031 529 001 9 031 529 001 09031529001 9031529001 09031529001 cobas pure c 303 analytical unit cobas c 303 07613336226971 Instruments Not Available Not Available cobas® pure integrated solutions is an automated analyzer, intended for running qualitative, semi- quantitative and quantitative clinical chemistry and immunochemistry assays as well as ion-selective measurements.Supporting informationcobas® pure integrated solutions is intended to be used by trained laboratory technicians.Target customers of cobas® pure integrated solutions are commercial and public clinical laboratories. en cobas® pure integrated solutions is an automated analyzer, intended for running qualitative and quantitative clinical chemistry and immunochemistry assays as well as ion selective measurements.Supporting informationIt is an IVD device intended to be used in combination with assays for screening, monitoring (aid in monitoring), diagnosis (aid in diagnosis) and prognosis; additionally, the device can be used to run companion diagnostic devices.The specific disorder and testing populations are covered by the applicable assays running on the instrument. The type of specimen to be used includes serum, urine, cerebrospinal fluid, supernatant, oral fluid, hemolysate, amniotic fluid, processed stool and plasma that are used for detecting and/or measuring analytes covered by the specific assays.The intended users of this device are trained laboratory technicians and trained field service engineers (professional use only). en

cobas^® pure integrated solutions

IVD

Simplicity meets Excellence

Today more than ever, the importance of accurate and timely diagnostics is clearly understood. The journey from blood collection to the final test result, however, requires the highest level of dedication, expertise and diligence of the laboratory staff.

To support you in this, Roche has developed innovative integrated solutions renowned for quality and excellence.

cobas^® pure integrated solutions is the newest member of the cobas^® family of systems which is designed to deliver excellence, while at the same time simplifying your daily work. cobas^® pure combines clinical chemistry, immunochemistry and ISE testing on a compact footprint, giving access to our broad menu of more than 230 parameters – including many unique high medical value assays – to labs who have to deal with limited space.

To simplify daily operation, cobas^® pure comes with new features that minimise the hands-on work for the operators, thus saving precious time.

To ensure simple and effective work for network organizations, cobas^® pure provides fully standardised results and operation to cobas^® pro integrated solutions – Roche’s latest analyser designed for larger labs.

Because simplifying any step of the journey can help deliver a fast and accurate diagnosis.

* Commercial availability of this product differs by country due to local regulatory approval timelines and/or local business strategy.

cobas^® pure integrated solutions - Simplicity meets Excellence

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Your time

Reducing hands-on time for the operators

Your space

Offering access to a broad assay menu on a compact footprint

Your team

Enabling reliable and simplified daily operation

Your future

Pioneering lab solutions and delivering greater medical value

Your time is precious

We help you use it wisely

In the lab, every minute counts - for you and your team, for the clinician and the healthcare institution, for the patient and their family.

Empower your clinicians to take action faster

Standards are being raised across health systems, as patient and clinician satisfaction and fast clinical decision making are becoming more prominent quality metrics. Choosing an analyser that supports short and predictable turnaround times at peak times is a key to meet these standards.

Get answers fast with short and predictable turnaround times.

cobas^® pure integrated solutions is designed to support fast and predictable turnaround times across all assays.

93 % of Roche immunoassays have a reaction time of 18 minutes or less, with STAT assays having just 9 min reaction time.²

To offer full transparency, cobas^® pure integrated solutions allows the operator to see the time to result per sample and per test as well as the time to last result on all ordered tests.

9 minutes

18 minutes

27 minutes

Benefit from reduced system preparation and hands-on time

Free up staff time with reduced hands-on maintenance efforts

With cobas^® pure integrated solutions, every effort has been made to reduce hands-on maintenance tasks to a minimum. The new and smart concept of self-operating maintenance executes maintenance tasks automatically in the background and reduces the manual burden of daily maintenance to 5 min.¹

Save time and costs with cobas^® AutoCal

The clinical chemistry module of cobas^® pure integrated solutions comes with a significantly simplified calibration concept - automated calibration. With cobas^® AutoCal, new reagent lots for the majority of clinical chemistry tests are calibrated automatically, without the need for manual calibration. This can lead to 56 % less calibration events, saving up to 105 hours of hands-on time yearly.*³

* For a common, daily routine workload, as compared to cobas^® 6000 analyser series (cobas® c 501 module, cobas® e 601 module) Mid Volume Commercial Lab

Your space is limited

We help you make the best of it

cobas® pure integrated solutions is designed to deliver true productivity for your lab and access to our complete Serum Work Area assay menu on a compact footprint of ~2 square meters

Consolidate clinical chemistry and immunochemistry on a single platform

One

sample tube for all CC and IM tests to handle

One

set of results to track

One

platform to manage and to be trained on

One

user interface to interact with

One

manufacturer to partner with

Three compact configurations*

Immunochemistry Configuration

Footprint 1.2 m²

cobas e 402 analytical unit

Serum Work Area Configuration

Footprint 2.0 m²

Clinical Chemistry Configuration

Footprint 1.2 m²

cobas c 303 analytical unit

*The width and depth dimensions shown here are the floor (footprint) dimensions⁴

Increase productivity with our improved reagent carriers in clinical chemistry and immunochemistry

Ready to use reagents

cobas^® pure uses the latest reagent generation from Roche - cobas® e pack green and cobas® c pack green. These reagents do not require any preparation, mixing, waiting or pre-opening. The operator can simply take them out of the fridge and load them directly onto the analyser.

No preparing

No mixing

No waiting

No pre-opening

Take out of the fridge

Load onto the analyser

Roche clinical chemistry portfolio

Roche immunochemistry portfolio

Industry’s leading onboard stability

Using space intelligently is about achieving the highest output within the existing space. The average onboard stability for the immunochemistry reagents is 110 days, with 98 % of the assays having an onboard stability of 4 months. The average on board stability for clinical chemistry is 137 days, with 57 % of the reagents having an onboard stability of 6 months.^5,6

Immunochemistry⁵

Up to 4 months onboard stability
≈ 3 times longer average onboard stability compared to previous generation systems

cobas® e pack green

Clinical chemistry⁶

Up to 6 months onboard stability
≈ 2 times longer average onboard stability compared to previous generation systems

cobas® c pack green

Your team is crucial to your lab's performance

We help them focus on the tasks that matter

Whilst the pressure to deliver continuously increases, keeping your team engaged and focused on value-adding tasks can be difficult but is of paramount importance for your lab’s success. The cobas® pure integrated solutions is designed to eliminate hurdles that may cause unnecessary stress.

Bring more confidence to your team with reliable results

Unplanned downtime and lack of confidence in results are some of the most stressful things that can happen in the lab. They shift attention to time-consuming, hands-on workarounds or sample reruns which can affect staff morale and motivation.

Additionally, they pose risks to the quality of results and the lab’s reputation. cobas^® pure integrated solutions is designed to deliver distinctive reliability through sound system architecture and confidence in the results through various safety features.

99 % uptime⁷of our existing portfolio of more than 75.000 analytical units globally

Reliable results¹

Disposable AssayTips/AssayCups

cobas^® pure immunochemistry analytical unit utilizes single-use disposable AssayTips and AssayCups to completely eliminate the risk of sample carry over.

Carryover evasion program

The sample probes on the cobas^® pure clinical chemistry analytical unit are rinsed inside and outside with deionized water each time after dispensing a sample. Additionally, for applications that are sensitive to sample carryover, a special wash can be programmed for an extra wash of reagent probes, sample probes and reaction cells with basic and acidic wash solutions.

Ultrasonic Mixing

The cobas^® pure clinical chemistry analytical unit features ultrasonic mixing for non-contact mixing of sample and reagent to eliminate the risk of carryover during this event.

Reliability

cobas^® pure integrated solutions is designed to deliver the reliability that Roche is known for. With more than 75,000 analytical units globally, the cobas family of solutions demonstrates a distinctive uptime* of more than 99 %.⁷Having a reliable analyzer means less interruption of services and less time spent on troubleshooting, thus higher productivity with more predictable turnaround times.

* Uptime: Percentage of the time when system is up and running vs. the time the system is not running due to unplanned incidents. Calculation:
(365 days/Mean time between repair visit) × (Mean time for repair visit + Travel Time)⁷

Enable your team to work more efficiently through standardised solutions

Lab standardisation enables you to do more work on fewer instruments, through consolidation of workflow, systems and reagents. Standardisation also provides efficient and compatible solutions for network cooperation.

Essential benefits of standardisation

Improved speed and accuracy of results

Same reagents and detection technology mean standardised reference ranges which improve the speed and accuracy of results.

Simplified training and staff allocation

Common user interfaces between our cobas^® systems simplify training and allow for flexible staff allocation as healthcare centers are consolidating into larger integrated health networks.

Optimised patient management

Consistent results over time and across different locations enable optimised patient management.

Same
reagents

Same
detection technology

Common
user interfaces

Same
reference ranges

Your future

We help you succeed through continuous access to innovations

Choosing the right solution and vendor to partner with is not a small undertaking - it is a choice that impacts your lab’s ability to fulfil performance and quality standards but also your ability to remain competitive. At Roche, we believe in the power of innovation to advance and improve diagnostics - for a better future of the patients and your lab.

Focused innovation of our assay portfolio

Extending evidence base

Extending the evidence base for existing assays through clinical studies to generate higher awareness and broader access to innovation.

New claims for existing assays

Generating new claims for existing assays for a wider range of application.

Discovery of new assays

Menu expansion in the areas of unmet medical needs to help clinicians improve outcomes for their patients.

Bring Personalised Healthcare to clinical practice

Supporting better patient care, contributing to health economics and empowering labs to play a greater role in medical decision making.

Delivering greater
medical value

Commitment to exceptional assay quality

Advanced assay design

Outstanding precision across measuring range
High sensitivity in areas where it matters
Wider measuring ranges, fewer dilutions and repeats

Consistent, standardised results

Consistent patient results across all platforms
Excellent lot-to-lot consistency
Assays standardised against reference method

Designed for convenience

Short and predictable assay turn-around times
Low sample volume
No reagent preparation required

Want to know more? Get in touch

cobas^® pure integrated solutions User Guide
Elecsys assay menu cobas pure – Analysis (source method sheets cobas e pack green).
cobas pure – AutoCal Estimated Time Savings – Internal Calculation.
cobas pure – footprint dimensions – Internal Document.
Elecsys assay menu cobas pure – Analysis (source method sheets cobas e pack green, CMP Database).
Clinical Chemistry assay menu cobas pure – Analysis (source method sheets cobas c pack green).
Roche Diagnostics Internal Reporting Data On File – GCS reporting / Product reports Q1/2020, CPS Finance Report from Tableau, ICB Q1 2020.

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cobas^® pure integrated solutions

Simplicity meets Excellence

We help you use it wisely

Empower your clinicians to take action faster

Get answers fast with short and predictable turnaround times.