College of American Pathologists
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  All eyes on broad test menus, integrated platforms


CAP Today




July 2008
Feature Story

Anne Ford

Anagrams are funny things. Rearrange the letters of some words or phrases, and an eerie truth sometimes emerges. “Slot machines” turns into “Cash lost in ’em.” “The Morse code” becomes “Here come dots.” To the delight of conspiracy theorists, “Elvis” = “Lives.” And, as laboratory equipment manufacturers appear to have intuited, hidden in the word “consolidate” is the telling phrase “Docs’ elation.”

That is, “the trend is platform consolidation,” says Patricia A. Shugart, MT, vice president of marketing for Carolina Liquid Chemistries. “Labs are looking to purchase instruments that will run the most tests on one platform.”

Why? Because, says Jeff McHugh, corporate vice president of Beckman Coulter’s Chemistry Systems Business Center, broader test menus make it possible for laboratories to reduce costs and improve patient safety at the same time. “Information generated from a lab accounts for only about five percent of total health care costs but influences 70 percent of health care decisions. So there is great value in a broad test menu that produces accurate results,” he says.

“Instrument purchasing decisions are increasingly moving towards integrated chemistry and immu­no­assay platforms,” McHugh adds. “Currently 10 to 20 percent of lab tests run on integrated platforms, but those numbers are expected to increase to 40 to 50 percent in the next few years.”

So, in this month’s survey of instru­ments, which covers mid- and high-volume chemistry analyzers, look for broader menus and combined chemistry and immunoassay testing, as well as other features designed to reduce costs, improve patient safety, and elate docs everywhere.

Just two months ago, Carolina Liquid Chemistries introduced to the U.S. market the BioLis 24i bench­top chemistry analyzer with upgraded soft­ware. At 32 in. wide and with a 100-test menu and a throughput of 400 tests an hour, the BioLis 24i can be used as a primary, special chemistry, or backup instrument. “This means that hospitals or physician offices can offer a wider array of testing on one platform, from your basic comprehensive metabolic panels to special cardiac testing,” Shugart says. The analyzer also performs special chemistries, from insulin and D-dimer to cystatin C and homocysteine. “These can all be loaded at one time and are stable for a minimum of 30 days,” she adds. “We have four placements since May. The consensus so far has been that they like the size, it delivers what we say it does, and it can offer a laboratory unrivaled revenue because of the stability and the way the reagents are packaged to eliminate waste.” In the future, look for specific proteins and infectious disease testing to move to the company’s chemistry platform.

Roche representatives say that in the two years since its launch, the Cobas 6000 consolidated clinical chemistry and immunoassay testing platform has done so well that Roche has introduced two additional configurations this year: the c 501|c 501 and the c 501|c 501|e 601. Both, say systems group marketing manager Ed Gilligan, cater to higher-volume laboratories. “We’re especially proud that the Cobas 6000 has gained such large-scale market acceptance in a short amount of time,” he says. “Part of that success is due to promises kept to customers to continue to expand our menu with diverse tests. We’re not sitting still.”

By way of evidence, Roche clinical chemistry group marketing manager Matt Manley points to the half-dozen assays Roche has introduced on the Cobas c 501 integrated clinical chemistry analyzer: U/CSF total protein, lithium, NAPA, phenobarbital, procainamide, and total mycophenolic acid. “In the near future, we plan to launch adulterants, EDDP, oral fluids, oxycodone, amikacin, quinidine, tobramycin, lidocaine, and cystatin C,” pending FDA review, Manley says. “And beyond 2008, Roche is planning to introduce more urine drugs-of-abuse assays, including adulterant tests, to further round out its panel.” To come in early 2009 is the stand-alone, automated Cobas c311 clinical chemistry analyzer. And in early 2010, Roche and partner OraSure Technologies are planning to launch fully automated oral fluid drugs-of-abuse tests (pending FDA review). “This technology is expected to initially include six assays and applications for Roche analyzers and other automated platforms that would then be capable of running both DAT urine and oral fluid tests,” says Manley.

Siemens Healthcare Diagnostics reports widespread customer satisfaction with the automation-ready Advia 1800 chemistry analyzer, fully launched in early 2007. Marketing manager Pamela Curtin says the company will soon introduce Advia 1800 connectivity to the VersaCell sample management device, which continuously loads and unloads sample tubes between analyzers. “Currently, the Advia 1800 chemistry analyzer and Immulite 2000/2500 immunoassay analyzers are available for connectivity,” Curtin says. “Sample tubes are moved efficiently between analyzers to maximize productivity and turnaround time. These VersaCell Combos will offer an affordable step to automation with faster routine and stat turnaround times, a comprehensive chemistry/immunoassay menu, and a decrease in operator interventions.” In the future, Siemens aims to release concentrated reagents for the Advia chemistry systems—specifically, 17 high-volume chemistry assays that, Curtin says, will double or triple the number of tests per reagent wedge.

Earlier this year, Beckman Coulter introduced the UniCel DxC 880i Synchron Access clinical system, the latest in a series of integrated workstations. The new system combines the company’s UniCel DxC 800 high-volume chemistry analyzer with its UniCel Dxl 800 high-volume immunoassay analyzer. Linking the two analyzers is the UniCel Closed-Tube Aliquotter, or UCTA, which functions as a single point of sample entry. “Flexibility is a driving force behind the UniCel DxC 880i,” McHugh says. “With the UCTA, a lab that already has the DxC 800 or the Dxl 800 can upgrade the system to the DxC 880i configuration.” The DxC 880i runs a combined chemistry and immunoassay menu of more than 150 tests, 120 of them onboard.

Finally, Randox Laboratories’ global product manager Julia Dunlop reports that the RX Imola—the newest clinical chemistry analyzer in Randox’s RX series—was launched in the U.S. market just a year ago. She calls its test menu “one of the best for analyzers of its size on the market,” adding that “Pyrex cuvettes, ready-to-use reagent bottles, and the ability to use onboard primary tubes help make the analyzer time- and cost-efficient.” Randox hopes to eventually introduce more specialized tests into the U.S. market as well.

CAP TODAY’s survey of mid- and high-volume chemistry analyzers includes products from the aforementioned manufacturers and from Abbott Diagnostics, Awareness Technology, Olympus America, Ortho-Clinical Diagnostics, and Teco Diag­nostics. Vendors supplied the information listed. Readers interested in a particular product should confirm that it has the stated features and capabilities.

Anne Ford is a writer in Chicago.

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