Immunoassay marketplace reflects need
  for integration

June 2007
Feature Story

Anne Ford

Any home cooks who’ve found themselves staring at a cabinet full of one-trick-pony kitchen gadgets—electronic cappuccino whisks, avocado slicers, hot dog toasters—lunderstand the virtues of consolidation. Who needs a salad shooter, an ice crusher, and a smoothie maker when a blender will do the job of all three? (Let’s not even get started on egg cubers.)

While there’s not a lot of cappuccino-whisking going on in the average laboratory, that doesn’t mean there’s no need for consolidation. “We have seen a growing need for analyzers to consolidate testing, offer a broad testing menu, and have the capability to integrate with chemistry systems or automation lines,” says Douglas Creelman, Beckman Coulter product manager for immunoassay systems.

And that need isn’t going away anytime soon, chimes in Kyle MacGibbon, Abbott marketing manager: “We expect the trend toward integrated systems will increase in all segments of the marketplace.” No surprise, then, that many of the products profiled in this month’s instrumentation survey (Related article: Survey of Instruments: Automated immunoassay analyzers ) reflect this movement toward integration, even while others satisfy the needs of laboratories that seek immunoassay-only solutions.

At the American Association for Clinical Chemistry Annual Meeting and Clinical Lab Expo in San Diego July 15–19, attendees can preview a rack builder track connection feature from Olympus America and view the system on which it will be available: the FDA-cleared Olympus AU3000i immunoassay system, which at this time last year was just about to be launched in Europe and the United States. How has it performed since then? “The Olympus AU3000i is holding true to Olympus standards for system reliability, and is delivering phenomenal precision for newly released thyroid and fertility assays,” says Lorraine Damico, director of immunoassay marketing. Olympus will also preview an open-track solution that will “allow immunoassay and chemistry platform combination and lab automation optimization,” she says.

AACC attendees will also get a sneak peek at the Binding Site’s forthcoming high-throughput open system, a followup of sorts to the company’s DSX immunoassay analyzer. Marketing manager Gary Tremain says the system will “share the same benefits as our DSX open system, but will also provide lower operating costs and the greater processing capacity demanded by our larger customers.” Other developments at the Binding Site include the Farrzyme high-avidity anti-dsDNA kit, a nonisotropic, IgG-specific assay that Tremain calls “highly specific for lupus nephritis and systemic lupus erythematosus with renal involvement”; and the diaDexus PLAC test, an automated application on the DSX platform that the FDA has cleared for risk stratification for stroke and for atherosclerosis leading to adverse cardiac events.

One of the newest instruments in this month’s survey is Beckman Coulter’s UniCel DxI 600 Access immunoassay system. At CAP TODAY press time, it had been available for about a month. Creelman says, “The DxI 600 is a full-feature system for mid-volume labs —a segment which represents more than 45 percent of the immunodiagnostic testing market worldwide.” Aimed at laboratories that support 200- to 400-bed hospitals, the instrument has an hourly throughput of up to 200 tests, releases primary tubes in less than five minutes, and includes onboard aliquoting and refrigerated storage for 50-reagent packs. In addition, “it uses the same reagent pack as other analyzers in the family, a feature important to integrated health care networks,” Creelman adds. Also new from the company: Access inhibin A, an automated assay that quantitatively determines dimeric inhibin A levels in human serum and plasma. He calls it “the first of many high-value immunoassays expected from Beckman Coulter’s acquisition of Diagnostic Systems Laboratories.” In addition, a soluble transferrin receptor assay is due out later this year. Creelman says it will “allow labs to recapture send-out tests or automate previously manual assays, promising to further improve turnaround times.”

Beckman Coulter customers can also look forward to the UniCel DxC 880i, an instrument scheduled for launch in December. “The DxC 880i will combine our high-throughput DxC 800 chemistry and DxI 800 immunoassay systems,” Creelman says. And next year, “we plan to release other combinations of integrated platforms to meet the differing needs of testing facilities and allow for further workstation consolidation.”

Meanwhile, Abbott’s MacGibbon says the Architect ci16200, an integrated instrument that combines the company’s c16000 chemistry and i2000sr immunoassay systems, will be available in the third quarter of this year and will “provide high-speed integration to high-volume customers.” In that same quarter, Abbott aims to launch the Architect i1000sr, a low- to mid-volume immunoassay system that will use the same technology, reagents, and software as the other instruments in the Architect family. “The i1000sr provides numerous productivity benefits,” MacGibbon says, “such as continuous access to reagents and consumables and the innovative robotic sample handler, which allows customers to customize and prioritize certain sample-handling functions.” Eventually, the i1000sr will integrate with the c4000 chemistry system that’s now in development.

Last summer, Roche introduced the Cobas 6000 analyzer series, including the Cobas c 501 clinical chemistry analyzer, the Cobas e 601 immunoassay analyzer, and the integrated Cobas 6000 analyzer series (c 501/e 601 analyzers). Now available: the Cobas e 411, aimed at the low- to mid-volume immunoassay market. Product public relations consultant Lori McLaughlin says its key features include a large menu, a nine-minute turnaround time for critical care tests, and the ability to “operate independently, as a dedicated stat analyzer, or as part of a networked clinical laboratory environment.” At CAP TODAY press time, Roche was planning to launch a total mycophenolic acid assay “to help manage MPA therapy in renal and cardiac transplant patients,” McLaughlin says. “The assay can be used with the Cobas 6000 series and the Cobas Integra series.”

Inverness Medical Professional Diagnostics has just introduced the AIMS, or automated immunoassay multiplexing system. An open system, it’s “the first fully integrated system that allows the processing of microplate-based assays utilizing the proprietary Luminex x-MAP-based technology as well as traditional ELISA-based assays,” says Instrument product manager Jennifer L. Solimani, MT(ASCP). “The system was designed to allow customers the ability to launch into multiplex testing with full automation from the beginning. Its flexibility allows customers to upgrade current AtheNA systems and grow into the AIMS system over time as their menu and ours continue to expand. Having the ability to perform fully automated ELISA-based assays on the same platform makes this a true multi-methodology analyzer.” By the end of the year, she adds, “the system will be able to be configured as either a disposable tip or fixed probe instrument, allowing even more flexibility.”

Two companies, Hycor Biomedical and Phadia, anticipate software updates this year. Hycor senior product manager Alexander Draffan Jr. says updates of his company’s Hytec 288 Plus software “generally include improvements in workflow requested by customers and system performance improvements developed by Hycor.” The next update will take place in the fourth quarter of this year, he says, and “has as its focus the extension of the calibrator curve to include a zero calibrator in Europe, and later in the United States.” 2008 will bring a higher-throughput in-vitro allergy system from Hycor as well.

Phadia’s software update is scheduled for later this summer, “in support of our recently FDA-cleared EliA assays,” says associate product manager Nicole Lampas. The company plans to introduce improved ImmunoCAP Data Manager software for its ImmunoCAP 100, 250, and 1000 instruments. The assays in Phadia’s EliA series include those for cyclic citrullinated peptide (CCP), tissue transglutaminase (tTG) IgA and IgG, and gliadin IgA and IgG. Other EliA assays, specifically those for dsDNA; cardiolipin IgA, IgG, and IgM; and antinuclear antibody are under development for release in the United States. The EliA assays, Lampas points out, are fully automated on the ImmunoCAP 100 and 250 instruments, feature a turnaround time of 2.5 hours, are performed under master IgX curves, and require one monthly calibration.

Trinity Biotech marketing manager Marlene Jinks says the latest news from her company is the introduction of the TrinBlot system, which she calls “a revolution in the automation of Western blot testing.” The system comprises a processor and scanner. “Once the assays are processed, the scanner uses innovative three-dimensional technology to digitalize test strips directly from the processor reaction tray to the main system,” she says. “The software then detects test strip bands and precisely links them to specific reference strips for results.” Trinity has also introduced a family of autoimmune disease tests with quantitative and qualitative interpretation options.

Within the next month, Tosoh hopes to launch its intact parathyroid hormone test on all of its AIA systems: the AIA-1800, AIA-600II, and AIA-360. “This test is pending FDA clearance, and we expect to see it in the market by July,” product manager Shanti Narayanan says. The AIA-360 instrument itself, introduced in 2004, is a near-patient, 60-pound testing system with a full menu and a throughput of 36 tests per hour. “The intact PTH on the AIA-360 is ideal for surgical suites, dialysis clinics, and stat laboratories,” Narayanan says, further noting that “Tosoh offers a unique dry reagent system that is common on all the Tosoh platforms. Laboratories prefer to use the same reagent system on the large immunoassay analyzers and smaller backup analyzers. Few manufacturers offer this advantage.”

Finally, DiaSorin offers a bouquet of recently released assays for its Liaison analyzer, such as that for Borrelia burgdorferi, which just came out in April. The Liaison varicella-zoster virus IgG assay made its debut in February. Both feature a turnaround time of 90 results per hour and a 35-minute time to first result. “DiaSorin also has a new direct renin test supporting its renin-based treatment initiative, pending FDA approval,” marketing manager Julie Kordosky says. “It is exciting because no automated method currently exists, and hypertension affects 50 million Americans.”

CAP TODAY’s survey of immunoassay analyzers includes products from the manufacturers above and from Awareness Technology, BioMérieux, Bio-Rad Laboratories, Dade Behring, Diamedix, Grifols USA, Ortho-Clinical Diagnostics, Randox Laboratories, and Siemens Medical Solutions Diagnostics. Vendors supplied the information listed. Readers interested in a particular product should confirm that it has the stated features and capabilities.

Related Links

• Survey of Instruments: Automated immunoassay analyzers (PDF, 1,761 K)