College of American Pathologists
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  Immunoassay analyzers: an ever-expanding selection


CAP Today




June 2011
Feature Story

Brendan Dabkowski

Benchtop random-access analyzers for esoteric testing. Instruments that grow as test volume grows. Larger capacity, stronger connectivity, and more automation. Tools for interpreting and presenting results. There’s nothing simple about laboratory wish-lists for immunoassay analyzers, but the nearly 70 systems profiled—most familiar, a few new—embody many wish-list wants.

Attendees at next month’s American Association for Clinical Chemistry annual meeting (see story, page 5) will see Tosoh Bioscience’s AIA-900 automated immunoassay analyzer. The FDA 510(k)-cleared analyzer, which the company will launch at AACC, has a throughput of 90 tests per hour and is available in three model types, says Tosoh senior product manager Shanti Narayanan. Model types include a standard instrument and versions with nine- and 19-tray sorters. Tosoh clients can purchase the standard AIA-900 and later add either the nine- or 19-tray sorter to boost testing capacity, Narayanan says. Still available from Tosoh are the AIA-2000, AIA-360, AIA-1800, and AIA-600 II analyzers.

Also set for release at AACC is Inova Diagnostics’ Bio-Flash rapid-response, random-access benchtop analyzer. The chemiluminescent instrument adapts quickly to workflow demands, including stat testing, and performs specialized tests, says Inova instrumentation product manager Edward Bass. The Bio-Flash provides results in as little as 30 minutes, producing up to 450 results in one shift, he says, and its stable, onboard reagents and calibration curves eliminate batching and improve test turnaround times. Random-access processing allows single or multiple assays to be performed at any time on any sample.

Appearing for the first time in the immunoassay analyzers product guide is Dynex Technologies, which recently launched its Agility platform. The easy-to-use micro¬≠plate testing system provides “the streamlined workflow of closed, random-access technologies while retaining the menu breadth, openness, and cost-effectiveness of microplates,” says immunochemistry marketing manager Michael Rashed.

The latest at DiaSorin is the Liaison XL analyzer, which received FDA 510(k) clearance in January and will be available in Europe and stateside in 2012. The fully automated analyzer will be on display at AACC, where the company will provide demonstrations of the system’s “flash” chemiluminescence and paramagnetic microparticle solid-phase technologies, says Brian Lauber, MT(ASCP), senior marketing manager at DiaSorin. On the assay side, the company recently released its Liasion MMRV IgG panel for detecting IgG antibodies to measles, mumps, rubella, and varicella-zoster virus.

Immunodiagnostic Systems, too, has reinforced its immunoassay lineup, adding human growth hormone and insulin-like growth factor 1 assays to the test menu of its IDS-iSYS automated immunoassay system, which, says group marketing manager Dennis Djan, is now UL certified. In an effort to “address clinical niches that are often poorly addressed,” Djan says that IDS expects to offer more specialty immunoassays, focusing specifically on those related to growth disorders.

New to the U.S. market this year are Phadia’s 2500 and 5000 immunoassay instruments—both previously available only in Europe—which product manager Nicole Vosters says “fulfill the need for high-throughput, fully automated immunology testing brought about by the growing awareness of the clinical utility that allergy and autoimmune diagnostics bring to primary care physicians.” Both systems run the company’s ImmunoCAP-specific IgE blood tests and EliA autoimmune assays. The Phadia 2500 has a throughput of 1,500 ImmunoCAP and 950 EliA results per eight-hour shift, and the Phadia 5000 has a throughput of 3,000 ImmunoCAP and 1,900 EliA results per eight-hour shift, she notes. Also in the guide are the Phadia 100E, 250, and 1000 laboratory systems.

Finally, Siemens Healthcare Diagnostics in March launched its Dimension EXL 200 integrated chemistry system. Designed for low-volume clinical labs, the EXL 200 features the company’s LOCI advanced chemiluminescence technology, allowing for fast, sensitive immunoassay testing, says Dave Hickey, CEO of the company’s chemistry, immunoassay, automation, and diagnostics IT unit. Hickey says the system’s test menu has more than 90 percent of the critical methods that physicians order and includes a cardiac stat menu with high-sensitivity troponin I results available in 10 minutes. Other features include a sample transfer module, sample clot check, and pediatric testing capabilities. On the test side, the company’s Advia Centaur vitamin D total assay was CE-marked in January for use on the Advia Centaur and Advia Centaur XP immunoassay systems. The assay is under FDA review.

CAP TODAY’s immunoassay analyzers product guide includes instruments from the aforementioned companies and from Abbott Diagnostics, Alere, Awareness Technology, Beckman Coulter, The Binding Site, BioM√©rieux, Bio-Rad Laboratories, Diamedix, Grifols USA, Hycor Biomedical, Ortho-Clinical Diagnostics, Radiometer Medical, Randox Laboratories, and Roche Diagnostics. Readers interested in a particular product should confirm it has the statedc features and capabilities.

Brendan Dabkowski is CAP TODAY associate editor.

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