College of American Pathologists
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  Much ado about size, standardization, simplicity, and
  specimen transport


CAP Today




December 2008
Feature Story

Anne Ford

If it’s not one of the formal laws of physics, it should be: The likelihood that a machine will malfunction is in direct proportion to the number of people who operate that machine. Your office photocopier—you know, the one that everybody from the clean­ing staff to the CEO uses, that’s always blinking “Error”—is no exception. Neither, unfortunately, are hematology analyzers, particularly those in laboratories where the labor shortage has forced workers who haven’t received specialized training to operate them.

This widespread “increase in the practice of using laboratory generalists instead of department specialists,” says Beckman Coulter cellular analysis group vice president Cindy Collins, means that “with so many people rotating through hematology, analyzers will have to be more efficient and easy to use.” At the same time, of course, the twin pressures of a graying population and a greatly reduced pool of laboratorians show little sign of easing up. So, she predicts, “Analyzers that are true to Lean principles will be in demand, as pathologists and lab directors seek to manage competing demands.” The vendors in this month’s instrument product guide, which addresses hematology analyzers, offer several new or forthcoming analyzers designed to help do just that.

This year Sysmex America introduced the XE-5000 hematology analyzer, which extends the capabilities of its predecessor, the XE-2100. Where the XE-2100 offered measurement of immature granulocytes, immature platelet fraction, and reticulocyte hemoglobin fraction as individual add-on options, they are available standard on the XE-5000. “These parameters require no additional sample pretreatment and are available 24 hours per day,” says Ralph Taylor, vice president of marketing and clinical affairs. And “because they are available on multiple analyzer platforms, we provide standardization for hospitals and clinics that are associated under an integrated delivery network.” In addition, the XE-5000 includes a body fluid mode with measurement of total white cells and red cells. “The body fluid mode also provides a WBC differential— polymorphonuclear and mononuclear cells for all fluid types, not just cerebrospinal fluid,” he says. “This feature is unique to Sysmex.”

“We have also achieved an overwhelming response to implementation of the Sysmex Work Area Manager middleware,” Taylor continues. The Sysmex WAM, as it’s known, can be added to the company’s hematology systems, thereby facilitating the creation of standardized rules for patient reports and QC review and delta checking. He expects the number of WAM implementations to double in 2009, even as updates to the middleware are in progress.

Those Lean principles Collins spoke of? They’ve been incorporated, she says, into Beckman Coulter’s UniCel DxH 800 Coulter cellular analysis system, which, at CAP TODAY press time, was scheduled for imminent release. The system, Collins says, was “designed with quality, reliability, and scalability in mind” and features “high-definition sample processing and multi-angle light scatter that can generate 10 times more data than traditional hematology analyzers.”

She’s particularly proud of the UniCel DxH 800’s enhanced decision rules. The instrument’s decision criteria not only reduce the need for manual review but also eliminate the need for manual intervention during repeat or reflex testing. “This is accomplished with the specimen transport module, a magnetically driven transport system that contains no exposed moving parts for maximum operator safety, and that will automatically return specimens to the sample aspiration module for repeat testing without operator intervention,” she says. “And its Intelligent Quality Monitoring capability maximizes instrument uptime—and makes it more reliable for technologists operating the system.”

Also due for release at CAP TODAY press time, pending FDA clearance, was Abbott Diagnostics’ Cell-Dyn Emerald, a compact, three-part differential hematology analyzer that diagnostics public affairs representative Don Braak­man calls “a high-performance, affordable solution for small to mid-size clinical laboratories.” Among its features, he adds: low reagent consumption, automatic cleaning and shutdown features, one-button startup, and a full touchscreen monitor for simplified operation. The instrument weighs less than 20 pounds and produces CBC results in 60 seconds, and, Braakman says, reports those results “in an easy-to-read format with histograms representing white blood cells, red blood cells, and platelets.” Another instrument, the Cell-Dyn Emerald 22, is in development; the company intends that this five-part optical differential analyzer will feature a compact design and ease of use similar to that of the original Cell-Dyn Emerald. Abbott already offers the Cell-Dyn Ruby, a smaller system that, Braakman says, “features a patented, all-optical technology referred to as MAPSS, for high first pass acceptance/low manual review rates and advanced yet intuitive software.”

CAP TODAY’s hematology analyzer product guide includes instruments from the aforementioned manufacturers and from Horiba ABX Diagnostics and Siemens Healthcare 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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