College of American Pathologists
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  Immunoassay: all eyes on efficiency, connectivity


CAP Today




June 2009
Brendan Dabkowski

CAP TODAY’s lineup of immunoassay analyzers, already 53 strong in 2008, has become even larger, thanks to companies that work hard and fast to give laboratories what they need. Of the 62 analyzers, 10 are appearing in this product guide for the first time and were released not long ago or will be soon.

“Laboratories are being squeezed from all sides to work more efficiently, with less labor. Doing more with less is definitely the marching order of most clinical laboratories,” says The Binding Site’s marketing manager Gary Tremain, who adds that laboratory professionals now request automation applications even for low-volume tests.

And, says Jean Metzar, director of global marketing, Centaur Systems, for Siemens Healthcare Diagnostics, the recession has only added to the pressure to be aggressive about efficiency and productivity. “The need to decrease labor, streamline processes, and improve workflow has resulted in increased demand for immunoassay systems with extensive menus, lab automation connectivity, and high-value software capability.” Siemens has seen a fast-growing interest in its Internet-based services and informatics solutions in labs of every type and size, she says.

The Binding Site’s ASP1200 IFA analyzer, new to the U.S. market as of last December, is one of the many solutions you will see in the survey. It automates immunofluorescence assay (IFA) slide processing, and when labs process multiple batches of slides, it “becomes a force multiplier for lab efficiency by redirecting labor to more productive, higher-level tasks and removing tedious, low-level repetitive operations,” Tremain says. The instrument frees up almost two hours of operator time in a typical IFA run. This summer, The Binding Site will introduce re-agent bar-code reading to its DSX automated system. This is the feature requested most by the company’s customers, he says.

Siemens’ Immulite 2000 XPi immunoassay system offers programmable auto-start, automated daily maintenance, automated sample rack loading and unloading, and a broad test menu, says Mark Smith, senior marketing manager of global marketing for Immulite systems. It is scheduled for U.S. launch later this year. Other changes this year for Siemens, he adds, include offering Advia Centaur XP immunoassay system connectivity to the StreamLab analytical workcell and VersaCell scaled automation solutions and a menu expansion (including automated infectious disease assays) and software enhancements for the Advia Centaur CP immunoassay system.

Radiometer Medical will introduce its AQT90 analyzer at next month’s American Association for Clinical Chemistry Annual Meeting and Clinical Lab Expo in Chicago. Designed for mid- to high-volume laboratories, the cartridge-based analyzer offers a small footprint, rapid startup, and fast measurement time, says Cindy Wuertz, RN, MBA, Radiometer’s marketing manager for acute care. The AQT90, to be released this summer, performs up to 30 tests per hour, with no sample preparation required—each sample is automatically mixed and measured. At release, the AQT90 test menu will include troponin I, myoglobin, CK-MB, and βHCG. Parameters in development include CRP, D-dimer, BNP, and troponin T.

Tosoh Bioscience’s senior product manager Shanti Narayanan says her company’s AIA-2000 automated immunoassay analyzer will be on display at the AACC meeting and is scheduled for U.S. release in August. The system offers a full test menu, with a throughput of 200 tests per hour. Similar to other AIA analyzers, the AIA-2000 uses the company’s unit-dose test-cup technology. “The AIA test cups come in dry reagent format and work with every Tosoh AIA system,” Narayanan says. “Since the reagents are interchangeable between different Tosoh AIA systems, transition is seamless, ensuring consistent results and efficient, economical operation for the laboratory.”

Beckman Coulter has three new integrated immunoassay/chemistry systems in its lineup: the UniCel DxI 660i, UniCel DxI 680i, and UniCel Synchron Access. All three analyzers receive samples from a single point of entry, and samples are automatically aliquoted and routed for analysis across both aspects of the platform, says Jeff McHugh, corporate vice president of the company’s chemistry systems business center. The i class systems offer a menu of more than 150 different tests, ranging from cardiac and tumor markers to tests for renal function and diabe-tes. Customers who already have UniCel DxC chemistry and UniCel DxI immunoassay systems in their labs can upgrade to an i class integrated system by adding the UniCel closed-tube aliquotter and supporting software, he says.

New at OrthoClinical Diagnostics is the Vitros 3600 immunodiagnostic system and Vitros 5600 integrated system. Both analyzers help labs address peak workloads and shorten turnaround times, says Betsy S. Hanna, vice president of clinical laboratory worldwide marketing. The Vitros 3600, which was cleared by the FDA in December 2008, sports a test menu of 47 immunoassays covering cardiology, oncology, endocrinology, infectious disease, thyroid, metabolic conditions, and anemia. The Vitros 5600, which received FDA clearance in October 2008, provides a sample-centered processing approach, intelligent sample handling, and dry chemistry technology, Hanna says. Both instruments have no water or drainage requirements, she notes, which helps minimize waste and allows for more flexibility in choosing where to put them. On the test side, the company’s Vitros anti-HIV 1+2 assay is pending FDA approval on both systems. (The Vitros 5600 is not part of the listing that starts on page 19.)

Also new to the market is the IDS-iSYS from Immunodiagnostic Systems and the AtheNa from Inverness Medical Professional Diagnostics.

AACC attendees will be able to preview next month Roche Diagnostics’ Cobas 8000 analyzer series, currently in development, which is “designed to bring next-generation consolidation to the high-volume testing lab,” says Ed Gilligan, group marketing manager for centralized diagnostics systems. The 8000 series’ immunoassay module is the Cobas e 602 analyzer (not yet in the CAP TODAY listing), a system offering “up to 170 tests per hour, 25 onboard reagents, and electrochemiluminescence technology for a broad measuring range and excellent low-end sensitivity.” The 8000 series is designed to include two clinical chemistry modules. The three individual modules can be configured with up to four modules per core unit, allowing for more than 19 combinations, he says. The 8000 series uses the same operator interface and standardized re-agent cassette concept as other Roche Modular platform analyzers and will have a peak throughput of 8,400 tests per hour and a maximum of 270 reagents onboard.

To open up laboratory floor space for mid-volume labs, Roche has introduced an equipment setup called the LEAP configuration. The automation solution combines the Cobas 6000 analyzer series, Modular Pre-Analytics Evo model C, and Roche middleware in three standard configurations that take up 86 square feet. The arrangement connects front-end automation to integrated analytics and middleware to achieve a single point of entry for up to 95 percent of a lab’s routine clinical chemistry and immunoassay testing, Gilligan says. Later this year or in early 2010, the company will add stat assay capability to its Cobas e 601 analyzer—introduced in 2006—for a nine-minute turnaround time.

Finally, Randox Laboratories will later this year unveil its Evidence MultiStat system. The fully automated benchtop system’s test menu includes cardiac and drugs-of-abuse toxic-screen arrays, says David Ferguson, Randox’s biochip customer support manager. The tests are run on a biochip platform, he says, which allows multiple analytes from a single patient sample to be assessed simultaneously. The company plans to add stroke, metabolic, cancer, diabetes, fertility, and thyroid arrays to the menu. Randox released this year additional markers for its fully automated Evidence analyzer and semiautomated Evidence Investigator system. This includes further cytokine, cerebral, drugs-of-abuse, and antimicrobial markers and DNA arrays, including for colorectal cancer.

CAP TODAY’s product guide for automated immunoassay analyzers includes systems from the aforementioned manufacturers and from Abbott Diagnostics, Awareness Technology, BioMérieux, Bio-Rad Laboratories, Diamedix, DiaSorin, Grifols Quest, Hycor Biomedical, Olympus America, Phadia, and Trinity Biotech. Companies supplied the information listed. Readers interested in a particular product should confirm that it has the stated features and capabilities.

Brendan Dabkowski is CAP TODAY associate editor.