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cobas^® i 601 analyzer

IVD

Enter a new dimension in mass spectrometry

With the cobas® Mass Spec solution, which includes the cobas® i 601 analyzer and the Ionify® reagents line, you can step away from tedious and complex manual mass spectrometry workflows and experience the simplicity and convenience of a streamlined end-to-end solution.

From sample preparation to result interpretation, Roche will be consolidating four technologies onto a single platform—ISE, clinical chemistry, immunochemistry, and mass spectrometry—maximizing efficiency and delivering enhanced medical value. Our solution is designed to enable smart testing through seamless physical and digital connectivity with other analytical units.

A broad assay menu of Ionify reagents is in development, complementing the clinical chemistry and immunoassay portfolio available on cobas pro integrated solutions. The assays include ready-for-use test kits with consistent performance and traceability to reference methods.

Enhance your lab’s capabilities by complementing existing methodologies and expanding services to new patient populations and disease areas with mass spectrometry.^1-3 The cobas i 601 analyzer allows you to streamline current workflows that require dedicated and specialized staff.

Contact us to discover how mass spectrometry can seamlessly integrate into your routine laboratory, enabling broader access to this transformative technology.

Benefits at a glance

Full automation—saving hands-on time

A total automated solution from sample preparation to result interpretation saving hands-on time for your operators.

Convenient and continuous sample loading
Random access processing: No waiting, sorting, or re-engineering required
Automated sample preparation from biological sample to purified analyte
Automated analyte separation: Automatic onboard mixing with 8 system reagents onboard and 8 channels of LC columns with efficient automated cleaning
Automated detection and quantification of analytes: Triple quadrupole mass spectrometer with electrospray ionization (ESI) technology
Automated result validation and reporting: Data processing, analyte quantification, result validation, reporting, and flagging

Seamless integration—improving productivity

Fully integrated* into routine clinical chemistry and immunochemistry testing, as well as laboratory automation, this solution enhances productivity in your lab.

Designed to meet your laboratory’s needs, the cobas i 601 analyzer is part of cobas pro integrated solutions and will work in combination* with cobas® ISE neo, cobas® c 503, and cobas® e 801 analytical units. It is also designed to integrate into pre- and post-analytics and IT solutions.

*At launch, cobas i 601 analyzer is available in a single configuration <cobas pro SSU | i 601>. All other configurations will be available at a later date.

High throughput—delivering fast turnaround times

The cobas i 601 analyzer has a high throughput with up to 100 injections per hour to fit the needs of your routine laboratory. This is made possible through its design features focused on automation, helping you deliver faster and more predictable turnaround times.

Broad assay menu—consolidating into one system

cobas i 601 analyzer offers a broad in vitro diagnostics menu of Ionify® reagents with more than 60 assays under development in the area of steroids, vitamin D, therapeutic drug monitoring, as well as drugs of abuse testing. They will be consolidated into multi-analyte, RFID-labelled reagent cassettes, which can be easily loaded and automatically registered into the system with 48 reagent channels.

Minimum downtime—reducing maintenance efforts

The cobas i 601 analyzer is designed to optimize operational efficiency and ensure seamless performance through a range of advanced features, including:

Automating the majority of maintenance tasks
Minimum daily operator intervention
Easy to perform, even for non-mass spectrometry experts
Step-by-step guidance for the operators
Continuous system monitoring to speed up troubleshooting and reduce time to repair

Traceability to reference methods—enabling consistent results

The cobas i 601 analyzer, Ionify reagents, methods, and workflows comply with the In Vitro Diagnostic Medical Device Regulation (IVDR). All assay designs, including pre-analytic and analytic protocols, data acquisition, and calibration and quality controls, provide an unbroken traceability chain to reference measurement procedures. This solution ensures quality performance, enabling consistent results across laboratories and supporting better patient care.

Simplified reagent handling—ensuring safety and ease of use

With standardized, ready-for-use reagent packs, cartridges, and system reagents, the cobas i 601 analyzer minimizes hands-on time. This design reduces operator contact with hazardous materials, enhancing both convenience and safety.

Integrating mass spectrometry into routine testing

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If you could envision the clinical laboratory of the future, what would it look like? The cobas® Mass Spec solution brings us closer to realizing that vision, enhancing support for physicians and, ultimately, benefiting patient care. Join us on this journey and discover new possibilities for your lab.

Show video transcript

If you could dream up a clinical laboratory of the future, what would it look like? The lab design, integration, and automation have always been central to Roche Diagnostics. Streamlined layouts, simplification of equipment and processes, complete automation. Over the years, we have pioneered the integration of all disciplines into the core lab. And more importantly, we connected the data. Finally, all the walls of the lab disappeared. Well, not quite.

Despite all these efforts, there is still one room that is separated from all the rest. Mass spectrometry. The advantages of mass spec are clear: superior sensitivity and specificity. Testing of metabolites and additional sample types, thus expanding the menu. But above all, it’s the quality of results that offers a competitive advantage. But to what cost?

Mass spec is extraordinarily complex, not only in technology but also in operation. It requires highly qualified personnel and continuous training. Due to the lack of integration and automation, large testing volumes are not possible, and standardization is an issue as well, not only between laboratories but also between individual instruments. So if you were to dream of the future of clinical mass spectrometry, it would look something like this. A device with fast turnaround time, high throughput, fully automated, connected to LIS, robust with standardized ready-for-use reagents, and all this fully integrated into the core lab, just like a cobas clinical chemistry analyzer. In short, it would look like…this!

The cobas Mass Spec solution. It’s a fully integrated sample-to-results solution. It has the same sample supply like all cobas pro units, including the STAT-sample port. The same cassettes design as the cobas immunochemistry analyzers, with ready-for-use reagents that can be exchanged at any time, without interrupting the routine. Only very few manual tasks remain, like for example loading samples, reagents, and consumables or waste disposal, but from here on the instrument will do most of the work fully automated, like ensuring the purity of the sample during the sample preparation process by the magnetic bead-based procedure. Samples will then be automatically transported to the Liquid Chromatography Unit. Multiple streams guarantee a high throughput. The columns come in specific cartridges: ready to use and with RFID labeling. The Mass Spec-Detector. From here the data will automatically be processed and the results will be validated, using sophisticated algorithms and then sent to the LIS. In the near future, there will be a comprehensive portfolio of assays, more than 60 parameters launched in two staggered waves.

Of course, the cobas Mass Spec solution is like all the other Riche instruments in the core lab designed to run 24/7. But the best thing is the flexibility of configuration. Choose yours according to your specific needs. And finally, the cobas Mass Spec solution is fully integrated into the core lab and cobas pro integrated solutions, together with immunoassay and clinical chemistry analyzers and ISE. So, in the near future, with cobas Mass Spec solution, all the walls will be gone and your dream of the laboratory of the future will have become reality for you physicians and ultimately for your patients.

Overview

Ordering Information

Explore the cobas i 601 analyzer

cobas® i 601 analyzer

Easy-to-use, fully automated, integrated, and standardized end-to-end solution bringing mass spectrometry to routine testing environments. It is part of cobas® pro integrated solutions, featuring a consistent design and user-friendly interface—reducing the need for extensive staff training.

Sample supply unit

Sample loading and unloading in a five-position rack with a capacity of up to 300 samples, allowing for continuous loading. STAT port for emergency samples.

Sample buffer

Designed to offer a true random access buffer for samples. Holds up to 25 five-position racks (125 samples). Positions can also be dedicated for STAT rack handling.

Sample preparation unit

Purification of the analytes occurs through paramagnetic particle-based sample preparation procedures, allowing automated testing in random access mode. The reagent manager consists of 48 positions in a cooled reagent rotor, enables the loading of reagent cassettes on the fly, and features an RFID reader.

Liquid chromatography unit

The system enables the separation of analytes via columns in ready-for-use cartridges with RFID labels. It incorporates both HPLC and rapid liquid chromatography (LC) technologies to cover different selectivities. Automatic onboard mixing of mobile phases and eight parallel channels of LC columns supports high throughput—up to 100 injections per hour—and allows for random access testing. Additionally, most system reagents can be loaded on the fly to maintain uninterrupted operation.

Mass spectrometry unit

Detection and quantification of the analytes occur in a triple quadrupole tandem mass spectrometer with electrospray ionization (ESI) technology.

Testimonials

Introducing cobas i 601: An expert’s opinion

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Introducing cobas i 601: An expert’s opinion

Prof. Michael Vogeser presents the scientific findings from his prototype study. Discover how this advanced technology could enhance clinical laboratory practices.

Unlocking clinical applications of mass spectrometry

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Unlocking clinical applications of mass spectrometry

Prof. Michael Vogeser explores how the benefits of a fully automated mass spectrometry solution will translate into improved patient care.

Revolutionizing mass spectrometry with the fully automated cobas i 601 analyzer

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Revolutionizing mass spectrometry with the fully automated cobas i 601 analyzer

Automation expert, Dr. Mads Nybo, discusses the impact of faster turnaround times, reduced manual work, and a broad assay menu on patient care.

Breaking barriers in therapeutic drug monitoring with cobas i 601 anaylzer

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Breaking barriers in therapeutic drug monitoring with cobas i 601 anaylzer

Dr. Pieter Vermeersch explores the clinical impact of automation on therapeutic drug monitoring and endocrinology.

Advancing clinical mass spectrometry with the cobas Mass Spec solution

Learn more about the impact of standardization on the speed and accuracy of results with Prof. Robert de Jonge.

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Contact us

Do you have questions about our products or services? We’re here to help. Contact a Roche representative in your region.

References:

Grebe SK, Singh RJ. LC-MS/MS in the Clinical Laboratory - Where to From Here?. Clin Biochem Rev. 2011;32(1):5-31.
Hristova J & Svinarov D. Enhancing precision medicine through clinical mass spectrometry platform. Biotechnology & Biotechnological Equipment. 2022;36(1):107-117.
Ketha SS, Singh RJ, Ketha H. Role of Mass Spectrometry in Clinical Endocrinology. Endocrinol Metab Clin North Am. 2017;46(3):593-613.

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cobas^® i 601 analyzer

Enter a new dimension in mass spectrometry

Benefits at a glance

Integrating mass spectrometry into routine testing

Overview

Ordering Information

Technical Documents