Automated lab systems particularly systems for automation of chemistry and immunochemistry testing, is the major area of new product development activity in clinical diagnostics. While automated laboratory systems, including systems that automate all phases of the testing process, have been available for some time, new products continue to be introduced that provide additional options addressing a wider range of laboratories.

The New Jersey-based Ortho Clinical Diagnostics, for example, described its evolving Fusion series of chemistry/immunochemistry analyzers that features a combination of dry chemistry slide and microvolume wet chemistry technologies to perform a wide range of assays on an integrated platform.

The first system, the 5.1FS, will be ready for shipment starting in 2003, and will eventually accommodate up to 80 different chemistry and special chemistry assays. Throughput will exceed that of any of the available Vitros analyzers, or more than 900 tests per hour. Ortho also reported the development of the 5.2FS high-volume immunoassay system; and the 5.3FS that will offer combined high-volume chemistry/immunochemistry capabilities.

Another system, the 3.1FS, will be targeted at labs requiring medium-volume chemistry testing capabilities, and the 3.2FS will be designed for medium volume immunochemistry testing. The 3.3FS will be a combined chemistry/immunochemistry system targeted at smaller or mid-sized labs.

While Ortho historically has relied on the advantages of its Ektachem dry slide chemistry technology, which employs a separation layer that typically excludes many interfering substances, to maintain a position among the market leaders in the global clinical chemistry segment, recent trends have demanded more advanced capabilities. The MicroTip technology was introduced in response to those demands, and Ortho is counting on the combination of technologies, along with enhanced chemiluminescence immunoassay technology in the future, to remain competitive. The Ortho systems feature a workstation philosophy that focuses on maximizing the efficiency and cost-effectiveness of specific segments of lab testing, rather than on attempting to integrate and automate all processes in the clinical lab.

Bayer Diagnostics (Tarrytown, New York) also is investing aggressively to enhance its product offerings for lab automation. Bayer's Advia 1650 clinical chemistry system has been well received in the market place so far. For example, Bayer recently announced a contract with Novation (Irving, Texas), a major supply company serving 7,700 members of three purchasing organizations including VHA Inc., University HealthSystem Consortium and HealthCare Purchasing Partners International, to supply immunoassay and lab automation products.

More than 500 Advia 1650 instruments are in clinical use worldwide, including more than 50 in the U.S. The 1650 can be interfaced to Bayer's high-throughput Centaur immunochemistry system to provide an integrated workstation (the Advia Workcell), an approach that many labs are adopting in the face of worsening shortages of lab technologists. By using a high-throughput system such as the Centaur, with a stat turnaround time of 19 minutes and a test throughput of 240 tests per hour, labs can eliminate batch processing of samples, running all specimens as they are received and lowering average turnaround time. For example, the laboratory at 325-bed Swedish Covenant Hospital (Chi-cago, Illinois) installed the Advia 1650 and Centaur workstation configuration and reduced turnaround time for tests requested by the ICU by 47 minutes, and turnaround time for routine tests was reduced to 95 minutes.

Even some larger labs, such as one at the 805-bed Wake Forest University Medical Center (Winston-Salem, North Carolina) performing 3 million tests per year, have found that the workstation approach can be attractive compared to total lab automation because of the extended return on investment (typically over three years), complexity, long implementation time and laboratory information system (LIS) interface issues associated with total automation. The Wake Forest lab succeeded in eliminating two full-time equivalent (FTE) positions in the chemistry/immunochemistry section, reduced stat immunoassay turnaround time from 60 minutes to 40 minutes (for Troponin I), and reduced stat glucose turnaround time from 45 minutes to 34 minutes by installing an Advia 1650/Centaur workstation consisting of two linked 1650/Centaur systems. Total workstations were reduced from 4.5 to one. A new Advia model, the 2400, has just been added to the Bayer line that offers higher throughput for chemistry testing.

Other leading suppliers of chemistry/immunochemistry/hematology automated workstation products include Abbott Diagnostics (Abbott Park, Illinois), Beckman Coulter (Brea, California), Roche Diagnostics (Indianapolis, Indiana), Dade Behring (Deerfield, Illinois) and Olympus Clinical Instruments (Tokyo). Abbott is developing the Architect instrument line, with the i2000 immunoassay instrument now available and the c8000 chemistry analyzer having just received FDA clearance.

Abbott next will focus on developing a linked workstation (the ci8200) comprised of the i2000 and c8000 instruments, providing a throughput of 1,400 tests per hour. Beckman Coulter's Synchron LXi 725 is the company's newest offering, allowing chemistry and immunochemistry testing to be performed from the same primary sample tube. The LXi 725 offers closed tube sampling and automatic specimen aliquotting. Throughput is quoted at 1,440 chemistry and 100 immunochemistry tests per hour, with a menu of 146 tests. Other products that compete in the workstation/lab automation segment include the Modular Analytics, Roche/Hitachi and Roche/Sysmex lines from Roche Diagnostics; Dade Behring's StreamLab, and the OLA 1500, OLA 2500 and OLA 4000 systems from Olympus.

The advancement of lab automation in the clinical diagnostics industry is continuing to expand as more suppliers enter the market with expanded automation options, and as shortages of lab personnel and increases in test volume in the industry require labs to perform more tests with fewer technologists. There are only about 300 labs worldwide that have installed total lab automation systems capable of handling all aspects of the testing process, from loading of the specimen tube to result generation for all the major lab disciplines (chemistry, immunochemistry, and hematology), while a number of others have automated one or more sections of the lab. The trend toward increased use of automation is expected to continue, with most of the growth in workstation-based automation rather than total lab automation. Based on information presented at the AACC conference by a number of labs that have adopted the workstation approach, most facilities can expect to reduce the number of instruments in chemistry and immuno-chemistry by a factor of two, and to reduce FTEs by a similar factor.

- (Courtesy: BBI Group)