By Chris Demiris

imageAdvances in automation and assay technology at Roche Diagnostics now make it possible to integrate clinical chemistry and immunoassay tests into a Serum WorkArea. This article outlines the enabling technologies that support the implementation of a Serum WorkArea and presents two approaches for its creation: operational integration and functional integration. Roche’s new Modular Analytics E170 module is an example of how the same module can be incorporated into each of the integration approaches. Guidelines to help determine the best solution for individual labs are provided.

The Serum WorkArea concept
Healthcare facilities today are focused on increasing productivity and enhancing service to clients. In response to this, laboratories are looking for ways to improve efficiency through labor-saving systems and processes that expedite the delivery of test results to physicians.

Recent advances have enabled laboratories to achieve this goal. While automation has reduced manual tasks, streamlined processes and increased sample throughput, new assay technology is enabling almost all serum testing to be performed on two systems: the chemistry analyzer and the immunoassay analyzer.

This level of consolidation opens the possibility of a Serum WorkArea, where sample-handling procedures common to different tests and test systems are integrated. For laboratories of all types and sizes, the integration of chemistry and immunoassay into a Serum WorkArea provides an opportunity to further increase efficiency by eliminating the operator intervention of transferring sample tubes from one system to the next.

Making it a reality
In recent years, automated clinical chemistry and immunodiagnostic systems have become increasingly cost effective and efficient as test menus expand and labor-saving features are added. Until recently, differences in technology and sample processing methods have prevented integration. However, these obstacles recently have been surmounted by Roche’s Elecsys family of immunoassay analyzers, which employs a Roche/Hitachi five-position sample transport rack and interface. These technologies make the Serum WorkArea a reality for high-volume core labs and for medium-volume hospital labs and satellite facilities.

Advances in immunodiagnostics
The electrochemiluminescence (ECL) technology of the Elecsys system makes automated immunodiagnostics as simple and routine as automated clinical chemistry while maintaining a broad test menu and high sensitivity. ECL technology offers broad measuring ranges and low-end sensitivity, thereby reducing the need for dilutions and repeats. The ECL technology is also flexible enough to accommodate a wide range of analytes; thus, its menu includes anemia, fertility, cardiac markers, tumor markers, thyroids and infectious disease. For ease of use, a two-dimensional “program by loading” barcode with an encoded master calibration curve minimizes manual data entry and simplifies calibration which only requires two points.

The three immunoassay analyzers that comprise the Elecsys family offer a range of throughput options. Two of them, the Modular Analytics E170 and the Elecsys 2010, may be configured as part of a consolidated Serum WorkArea.

The newest Elecsys system is the high- to ultrahigh-throughput Modular Analytics E170 module which can serve as a standalone analyzer or as part of a modular system in combination with Modular Analytics clinical chemistry modules. A single E170 module can run 170 tests per hour, and up to four E170 modules can be combined for a throughput of 680 tests per hour. That’s with up to 100 assays onboard and six hours of walk-away time. The modular design means labs can start with a single module and expand capacity as workload increases.

The Elecsys 2010 with a throughput of up to 88 tests per hour is designed for medium- to high-volume laboratories. It can be incorporated into a Serum WorkArea with other Roche/ Hitachi systems or used as a stand-alone system.

The Elecsys 1010 is designed for stat testing in emergency rooms and clinics and for low-volume facilities.

The five-position sample rack
Automated clinical chemistry and immunodiagnostic systems provide the basis for serum sample testing, but the only way to successfully integrate these systems into a Serum WorkArea is through a common system-sample interface. Roche Diagnostics has addressed this requirement by developing a proprietary five-position sample rack. The Roche/Hitachi five-position rack allows samples to be transferred directly between instruments and transports samples between modules in the consolidated Modular Systems configuration, eliminating the need for operator intervention.

Two approaches to integration
Determining the optimal integration approach to creating a Serum WorkArea depends on whether a laboratory plans to configure the Serum WorkArea with stand alone systems, an integrated chemistry and immunoassay system or a combination of the two. After working with a variety of labs, Roche has developed two integration strategies.

Operational integration
Operational integration is defined as a Serum WorkArea achieved by integrating Cobas Integra or Roche/Hitachi clinical chemistry systems and Elecsys immunoassay analyzers using the Roche/Hitachi five-position sample rack. The five-position rack provides a common sample-system interface, simplifies sample transport and allows sample tubes to move from one analyzer to another without any manual re-sorting. For even greater convenience, samples can be transported by a conveyor belt. The rack is compatible with the Elecsys 2010 System, Cobas Integra 800 analyzer and Modular Analytics, including the Elecsys E170 module. Roche’s Task Targeted Automation (TTA) systems can be added for sample decapping, sorting, aliquoting and archiving. For laboratories that already use Roche/Hitachi or Cobas chemistry analyzers, operational integration is relatively simple.

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Operational integration with the Roche/Hitachi five-position rack improves productivity by minimizing operator involvement in sample transport.

Operational integration benefits

Uses existing analyzers
Easily right-sized to meet sample capacity and throughput needs
Can replace or add, upgrade or replace analyzers to accommodate changes in throughput or assay requirements
Can add TTA as required for pipetting, diluting, sorting and archiving
Cost control; solution grows with needs

Functional integration
Functional integration of the Serum WorkArea is defined as the physical integration and consolidation of clinical chemistry and immunodiagnostics onto one platform with one single-operator interface. This is achieved using Modular Systems, which use a bi-directional sample transport system. With this approach, there is no operator intervention in sample transport. Immunoassay and clinical chemistry tests are performed in one pass across a menu of close to 130 chemistry and immunoassay tests. If desired, pre-analytic and post-analytic sample processing can be automated, and/or TTA can be employed for automated sample decapping, sorting and archiving.

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Functional integration allows integrated linking of pre-analytic, chemistry and immunoassay modules for one-pass sample processing.

Functional integration benefits

Highest level of efficiency and productivity
One-pass sample processing improves productivity by eliminating labor-intensive and time-consuming sample splitting and transfer steps
Adapts easily to changing sample capacity; easy-to-install modules can be added as required
Pre-analytical module adds fully automated centrifuging, decapping, aliquoting, sorting and archiving capabilities
Demonstrated labor savings and improved turnaround time
Reduced training and systems costs
Choosing the right integration approach for your lab

The most obvious benefits of functional integration are increased efficiency and productivity gained by eliminating manual sample handling and processing. (For example, using Modular Systems, the core clinical laboratory at the University of Chicago increased its workload by 30 percent in 18 months without adding staff.) Modular Analytics modules are operated by one user and from one LIS interface. This reduces system training, operating costs and offers the flexibility to optimize workflow by routing samples to various modules. In addition to efficiency gains, laboratories may realize improvements in turnaround time, because samples are directed automatically to the appropriate chemistry or immunodiagnostics module.

While integrating systems is a common goal of many laboratories, no single approach works for every lab. Before determining which approach to take, the laboratory’s characteristics, goals and requirements should be thoroughly evaluated and understood. To help its customers reach this level of understanding, Roche Diagnostics performs a “work area process analysis,” the basic parameters of which are listed below.

• Staffing resources
• Throughput requirements
• Types of samples
• Tube sizes
• Sample arrival rate
• Stat requirements
• Aliquots
• Test location by analyzer
• Sample preparation methods
• Post-analytic processes
• Laboratory goals (i.e., improve turnaround time, consolidate testing, reduce training requirements)

Other considerations in planning a Serum WorkArea include the lab’s floor plan, the types of analyzers used and the desire to incorporate them. It should also be noted that operational integration could be viewed as a stepping stone toward functional integration. By choosing operational integration, the option for functional integration at a future date remains open.

Chris Demiris is marketing mangager of immunoassay systems at Roche Diagnostics in Indianapolis.

For more information, select Reader Service Number 260 on the Reader Service Card, or contact Roche Diagnostics at 1-800-981-8863 or