College of American Pathologists
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  Powerful possibilities for low-volume laboratories


CAP Today




October 2008
Feature Story

Anne Ford

When Apple released the iPhone 3G this summer, it was a veritable Christmas in July for gadget geeks. Like the original iPhone, the already-über-popular 3G combines the abilities of an MP3 player, a cell phone, a camera, and an Internet browser with a sleek, simple interface. Perhaps most impressive, in combining these technologies in an easy-to-use format, Apple sacrificed comparatively little of each technology’s functionality. With either version of the iPhone (and reasonably dexterous fingertips), you can read the online New York Times nearly as easily as you can on a desktop computer, and listen to a tune even more easily than you can on a CD player. In short, it’s the top contender for title of “Smartest Smart Phone” (at least until Google’s similarly equipped T-Mobile G1 phone hit the market this month—but that’s another story).

That marriage of an easy-to-use interface with full or near-full functionality is a winning combination in the laboratory, too. That includes chemistry analyzers for low-volume laboratories. “Any offering in this area will need to be very simple to use, but will need to have results that match what physician office laboratories are getting from the reference labs and the hospital labs that they are currently using,” says Dennis Taschek, Alfa Wassermann vice president for reagents and instrument technologies. In other words, customers just aren’t willing to sacrifice functionality for convenience. Watch for this and other trends in this month’s instrumentation product guide (pages 22–42), which covers chemistry analyzers aimed at labs with lower testing volumes.

Horiba ABX’s upcoming offerings for this market include a smaller benchtop chemistry analyzer scheduled for launch next year. Chemistry product manager Chuck Rebisz says: “The new, smaller-model analyzer will feature a large menu of plug-and-play cassettes and an easy-to-use touchscreen validation station similar to that of our existing ABX Pentra 400 analyzer. It will also feature open channels for customer-specific applications.” Also to come from Horiba is a middleware product that will manage quality control and patient sample data transmitting from any of the company’s hematology and chemistry analyzers. “Many POL offices do not want to spend the dollars for an LIS but understand the value of having a middleware that connects their hematology and chemistry analyzers and hands the data off to an EMR system,” Rebisz says.

Available since March from Response Biomedical Corp. is the RAMP 200 for cardiac markers, which director of clinical support Marcia L. Zucker, PhD, calls “a modular system allowing the user the flexibility of having an instrument that can perform two, four, or six individual assays simultaneously,” whether those assays are multiple tests for a particular patient or individual tests from multiple patients. “This allows clinicians to define their own cardiac panels specific to their patients’ conditions.” Customers should note that, at the moment, the system is also marketed by 3M Health Care as the 3M Rapid Detection system for influenza A and B testing. In addition, as of next year, Roche Diagnostics will be marketing it (and the rest of Response’s cardiac marker product line) under the Roche brand.

Pending FDA approval, Randox Laboratories will, in the coming months, release its Rx Monza semiautomated clinical chemistry analyzer into the U.S. clinical market. “Its design and specifications put it top of its league,” says global product manager Julia Dunlop. “With a growing testing menu designed to mimic the capabilities of automated equipment, it is set to be an ideal analyzer for low-volume testing.” She notes that while the Rx Monza’s “possible applications are numerous,” its “clinical usage lies within the field of research, small-volume testing, backup support, or esoteric test analysis.” In addition, Randox is busily expanding the test menu on its Rx Daytona clinical chemistry analyzer, a smaller platform that is expected to soon offer more than 20 new or improved tests, including cystatin C, ceruloplasmin, drugs of abuse, and haptoglobin (FDA approval pending, of course).

Carolina Liquid Chemistries reports that it is planning to introduce the ability to run an LIS and the company’s BioLis 24i analyzer on one computer, along with three additional interfaces to other lab equipment. Patricia A. Shugart, MT, vice president of marketing, expects the new option to be especially helpful for the low-volume user who needs but can’t afford an LIS. “Our team of technologists has been working with innovative LIS companies to help bring this concept to market,” she says. “Our technical consultants will work with the laboratory to determine which LIS is the correct fit for its particular situation.” She invites low-volume laboratories to the company’s demonstration center to see for themselves how the new function works. In the meantime, Carolina has already begun including a water system with the BioLis 24i; the system “eliminates the need for the low-volume user to purchase water cubes, pay for shipping, and find storage space,” Shugart says.

“A keen interest in platform consolidation, cross-portfolio standardization, broad menu capability, and advanced automation”—those are the major trends in the low-volume chemistry analyzer market, says Diane Bandy, MT (ASCP), Siemens Healthcare Diagnostics chemistry/immunoassay systems marketing manager. As of last year, the company’s Dimension Xpand Plus integrated chemistry system (aimed at clinical labs performing fewer than 250,000 tests annually) features the QCC PowerPak efficiency enhancement package, which bundles automated calibration and control processes with expanded data storage.

Finally, Alfa Wassermann offers the Alfa S40 clinical chemistry system, a small-footprint analyzer that includes LIS connectivity. Hitachi manufactures it exclusively for Alfa Wassermann, and the companies plan to continue their partnership “to develop the next-generation system for low-volume sites,” Taschek says.

CAP TODAY’s survey of chemistry analyzers for low-volume labs includes products from the aforementioned manufacturers and from Abaxis, Abbott Point of Care, Beckman Coulter, The Binding Site, Medica Corp., Nova Biomedical, Ortho-Clinical Diagnostics, Polymedco, Roche Diagnostics, SDI Biomed, and Vital 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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