College of American Pathologists
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  Immunoassay analyzers: here and on the horizon


CAP Today




July 2012
Feature Story

Brendan Dabkowski

Take a peek at the products in this month’s immunoassay analyzers guide and you’ll see three newcomers and numerous expanded test menus. Read between the lines and you’ll see companies’ increased focus on flexibility and scalability.

“Laboratories are looking for total quality solutions that can meet their demands” and that are scalable and flexible, says Abbott Diagnostics’ marketing representative Shar Batley. Also fixing on flexibility is Dynex Technologies. “We have definitely seen an increase in the requests of labs to work more directly with the instrument manufacturers and then add assays and increase sample volumes after the instrument choice has been made,” says marketing manager Michael Rashed.

Attendees at this month’s American Association for Clinical Chemistry annual meeting can check out Dynex’s Agility immunoassay microplate processor. The FDA 510(k)-exempt open system processes up to 12 assays and plates in a single worklist and features separate sample and reagent pipettors, along with a transport arm, allowing several microplates to be processed simultaneously, Rashed says. Designed for large-capacity labs, the system holds 200 samples onboard, and all reagents and consumables can be loaded in bar-coded carriers to track inventory and lot-specific assay information.

Appearing for the first time in the immunoassay analyzers guide are Bio-Rad Laboratories’ PhD Ix immunoassay system and PR4100 Microplate Absorbance Reader. Launched in April, the PhD Ix features EIA and IFA processing and in-well dilutions to 1 μL of sample, says senior product manager Mary Borick, MT(ASCP). The system can be programmed to instantly create worklists from lab information system test orders, automate assays, track actions via audit trails, and apply the digital signatures of users with supervisor-level authority. The PR4100, introduced in March, is a 96-well absorbance reader that measures optical density in liquid media. The system includes sample plate maps for 105 predefined Bio-Rad methods and sample identification input via an optional handheld bar-code scanner, Borick says. The reader allows users to validate assays and interpret and print results and export them to an LIS. Custom methods can also be programmed into the software.

Siemens Healthcare Diagnostics, in May 2011, received FDA clearance for its Immulite 2000 XPi immunoassay system, says Marc Redman, vice president, chemistry and immunoassays, diagnostics division. Designed for medium- to high-volume labs, the analyzer offers a broad test menu, automatically loads and unloads sample racks, and connects with the company’s VersaCell system, which can connect two standalone instruments in flexible configurations. Also new from Siemens is a vitamin D assay for the Advia Centaur XP immunoassay system. Siemens continues to enhance its systems’ test menus, says Redman, adding that AACC attendees will be able to explore the company’s full spectrum of assays via interactive touchscreens.

Another vendor expanding its test offerings is Tosoh Bioscience. The company has added a homocysteine assay—recently cleared by the FDA—to all of its automated immunoassay platforms, says senior product manager Shanti Narayanan. Those platforms include the AIA-900, AIA-2000, AIA-360, AIA-1800, and AIA-600 II analyzers.

The Binding Site, too, recently strengthened its immunoassay product line, adding albumin, C3, C4, haptoglobin, and prealbumin to the menu of its SPAplus analyzer. Several more tests will be available later this year, says product manager Maureen Zetlmeisl.

Awareness Technology will introduce new immunoassays for TORCH, autoimmune, and infectious diseases at AACC, says company president Mary Freeman. Later this year, Awareness will release an automatic dual-function benchtop open analyzer with a single-reader module that combines photometric and chemiluminescent assay capabilities. Because Awareness serves low-throughput labs, Freeman says, the company is cognizant of the “increase in the commercial availability of assays and instruments that do not require large batches or fresh calibration curves with each run, and assays supplied in smaller package sizes.”

Still a staple at Abbott is the Architect family of immunoassay analyzers, all of which, Batley says, have identical software and use Chemiflex technology—a combination of refined chemiluminescence detection along with flexible assay protocols—to enhance assay performance. In addition to its immunoassay solutions, Abbott is showcasing at AACC its OneLab informatics platform, slated for release in the United States next year, and Accelerator a3600 and p540 automation solutions, “which will be coming soon as well,” Batley adds.

Launched last year was Inova Diagnostics’ Bio-Flash rapid-response chemiluminescent analyzer. The system provides the first test result in 30 minutes and additional results each minute thereafter, processing up to 450 samples in one shift, says instrumentation product manager David Moore. Onboard reagents, with calibration curves that are stable for an entire lot, help reduce the need for send-out tests. True random-access processing eliminates reagent waste and the need for isotype batching, he adds.

Finally, Beckman Coulter continues to offer its Access 2, UniCel Dxl 600, and UniCel Dxl 800 scalable immunoassay analyzers, says senior marketing manager Jim Rigo. Beckman continuously modifies its analyzers based on customer suggestions, Rigo says. “Our customers are always looking for expanded test menus.” Recent improvements to the products are automatic sample rerun, faster startup response, and accelerated data query functions.

CAP TODAY’s immunoassay analyzers product guide includes instruments from the aforementioned companies and from Alere, BioMérieux, Diamedix, DiaSorin, Grifols USA, Hycor Biomedical, Immunodiagnostic Systems, Ortho-Clinical Diagnostics, Radiometer Medical, Randox Laboratories, Roche Diagnostics, and Thermo Fisher Scientific. Readers interested in a particular product should confirm it has the stated features and capabilities.

Brendan Dabkowski is CAP TODAY associate editor.

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