College of American Pathologists
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  Vendors toil and tinker to refine chemistry analyzers


CAP Today




July 2011
Feature Story

Brendan Dabkowski

The work of a Broadway director is a behind-the-curtain affair. With a steady hand, encouraging words, and creative foresight, she smooths production wrinkles, calms jitters, and transforms dress rehearsals into applause-worthy performances.

And just as directors tackle numerous challenges in pursuit of critical acclaim, makers of mid- and high-volume chemistry and chemistry/immunoassay analyzers (the focus of this month’s product guide, PDF, 260 KB) toil behind the scenes, addressing their customers’ requests and changing needs in pursuit of client satisfaction.

Stepping into the spotlight at Carolina Liquid Chemistries are the CLC 480 and 720 chemistry analyzers. Both systems, which are pending FDA 510(k) clearance, will appear this month at the Clinical Lab Expo, part of the American Association for Clinical Chemistry annual meeting, says vice president of marketing and sales Patricia A. Shugart. The CLC 720, designed for mid- to high-volume laboratories, has a menu of 90 assays and processes more than 550 tests per hour. It operates quietly, consumes little water, generates little heat, and runs on Windows software, Shugart says.

Carolina’s CLC 480 is a benchtop system for the stat lab, special chemistry (rheumatoid factor and specific proteins) lab, physician office lab, or small hospital. It processes 400 tests per hour and can run the basic panels as well as drugs of abuse and about 80 chemistries, Shugart says. “Our goal is to be able to have a vitamin D on it, but we are still fine-tuning the application,” she adds.

Beckman Coulter bases its chemistry and chemistry/immunoassay systems on in-depth customer consultation, says director of customer relations Jim Rigo. Through such consultation, he says, the company has learned that its customers want products with enhanced remote diagnostic capabilities and broad onboard test menus and that are highly scalable. Enter the company’s AU680 chemistry system, which is intended to help mid- to high-volume laboratories improve test turnaround time and overall productivity. The system can run 1,200 assays per hour and has an onboard capacity of 63 different tests. Triple-reagent dispensing allows the AU680 to perform assays requiring up to three types of reagents, Rigo notes.

Preparing for its debut is Beckman’s AU5800 clinical chemistry system series, which is geared toward very-high- to ultra-high-volume labs and can process up to 8,000 tests per hour. The company will sell the AU5800 series in four scalable models, which are expected to be available in the fourth quarter of this year. The AU5800 will make a cameo at AACC, Rigo says.

Set for full-scale launch at AACC is Randox Laboratories’ RX Suzuka clinical chemistry analyzer (not yet in the CAP TODAY product guide), which processes up to 1,200 tests per hour. The fully automated, discrete, random-access clinical chemistry system has 10 stat positions for urgent samples and runs up to 44 tests and three ion-selective electrodes at the same time, says marketing manager Chris Henry. A built-in inventory management system automatically calculates reagent volumes and the number of tests available, alerting users to shortages. The system also has cooled reagent carousels and 50 cooled control and calibrator positions that allow control material to remain onboard without compromising stability. Because large test menus are the “order of the day,” says Henry, the RX Suzuka’s list of assays is extensive, covering autoimmune, metabolic and bone profiles, cardiac, diabetes, electrolytes, and more.

Large test menus are a priority too at Siemens Healthcare Diagnostics. Joining the company’s Advia chemistry menu, which includes more than 100 tests, are new assays that measure ferritin, beta-2-microglobulin, and alpha-1-acid glycoprotein, says Dave Hickey, CEO of the chemistry, immunoassay, automation, and diagnostics IT business unit. (The ferritin and beta-2-microglobulin assays are not yet for sale in the United States.) In addition, he says, many of the Syva Emit II Plus, Syva Emit 2000, and Emit specimen validity assays for testing drugs of abuse and therapeutic drugs are now available on the Advia 1800 and 2400 chemistry analyzers. And the company recently released software updates for these analyzers—version 2.01xx for the 1800 and 4.01xx for the 2400—which include calibration, quality control, and reagent management enhancements. Other enhancements include functionality for communicating with laboratory automation systems, immediate test result reporting, test utilization statistics, and the company’s RealTime Solutions remote diagnostic monitoring service.

With an eye on balancing workload and improving sample management, Siemens is linking more of its products to its VersaCell sample-management device, which continuously transfers sample tubes between analyzers. The company’s Dimension EXL with LM, Dimension EXL 200, and Dimension RxL Max systems now connect to VersaCell. “The new connectivity options create specific, needs-based workstations, combining two Dimension EXL systems or the Dimension EXL system with an immunoassay platform,” Hickey says.

Finally, Roche Diagnostics’ Cobas 8000 modular analyzer series has received FDA 510(k) clearance. The next-generation high-volume integrated platform includes the Cobas c 701 and Cobas c 502 clinical chemistry modules. The entire system has 24 unique modular configurations and can process up to 9,800 tests per hour.

CAP TODAY’s guide to mid- and high-volume chemistry and chemistry/immunoassay analyzers includes products from the aforementioned companies and from Abbott Diagnostics, Awareness Technology, The Binding Site, and Ortho-Clinical Diagnostics. Readers interested in a particular analyzer should confirm it has the stated features andcapabilities.
Brendan Dabkowski is CAP TODAY associate editor.

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