College of American Pathologists
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  Plenty that’s new and improved in
  coagulation market




CAP Today



January 2008
Feature Story

Anne Ford

How is operating a coagulation analyzer like riding a bike?
It isn’t. At least, it isn’t always. Give a kid a Schwinn and enough free time, and once she figures out how to pedal without falling over, she’ll know how to do it forever. But training a laboratory technician on Analyzer A doesn’t always mean she’ll remember all its bells and whistles after she’s spent a month or two working with Analyzer B down the hall.

That’s why, says Jackie Hauser, U.S. hemostasis marketing manager for Siemens Healthcare Diagnostics, “the analyzers need to be easy to operate and maintain,” especially “with so much cross-training in labs striving to do more testing with fewer techs.” That same more-testing-fewer-techs combination leads Larry Wright, Diagnostica Stago’s U.S. systems product manager, to note that “the lab, with more generalists and fewer specialists, is more dependent on the manufacturer for technical support and rapid availability of service for the instruments.” Balancing that emphasis on ease-of-use and support with perpetually evolving instrument menus and capabilities is the aim of the six vendors in this month’s instrumentation survey, which focuses on coagulation analyzers.

To complete its Destiny family of instrumentation, Trinity Biotech will be launching the high-volume Destiny MAX analyzer this year. “The most important aspect of this analyzer introduction,” says Kevin McGlinchey, MT(ASCP), hemostasis marketing manager, “is that we will now be able to offer a complete testing solution and standardization for any size laboratory or health system. And the unique design of the analyzer will allow us to easily connect to laboratory automated systems.” He adds that the instrument will use the same consumables and reagents as the other analyzers in the Destiny series, and that the instruments in the series “offer the ability to perform mechanical, optical, chromogenic, and immunoturbidimetric testing on the same platform while using half the amount of patient sample and reagents to perform routine coagulation tests.” The Destiny MAX will also incorporate some of the features of the company’s MDA analyzer, among them waveform analysis, the use of blue dyes to confirm probe aspirations, use of multiple wavelengths, and factor parallelism

Meanwhile, Helena’s point-of-care/hemostasis division manager Jim Campbell, MT(ASCP), MPH, announces that his company is on the verge of releasing a new coagulation system, the Cascade POC. “Initial tests on the system will be PT—both fresh whole blood and citrated whole blood—PTT, ACT, and low-molecular-weight heparin,” he says. The system will feature single test cards that use 30 to 35 µL of sample. “There are a number of other tests to follow in 2008, including measure of direct thrombin inhibitors and fibrinogen,” Campbell says.

Other new coagulation analyzers on the horizon include an addition to Beckman Coulter and Instrumentation Laboratory’s ACL TOP instrument family. “This instrument is similar to the ACL TOP CTS but will have a smaller footprint,” says Venita C. Shirley, Beckman Coulter hemostasis instruments marketing manager. The new analyzer, which Shirley expects to be available early this year, follows on the heels of the ACL TOP CTS launch in 2007. Able to report as many as 360 tests an hour, the CTS instrument can report first results in three minutes, features control material with 24-hour room temperature stability, and allows the user to program QC at any hourly interval. The CTS’ ease of use makes it especially attractive to understaffed laboratories, Shirley says. “The instrument can tell the operator what is required to run any test, routine or specialty. This feature allows operators with a minimal amount of training to become highly efficient.” In addition, Beckman Coulter is working with Instrumentation Laboratories to develop what Shirley calls “a complete automation solution for coagulation testing.”

“Some coagulation instruments have been adapted to automation lines, but the reality is that the interface of the instrument on the line prolongs the lab’s turnaround times instead of reducing them,” she says. “We have in development an automation solution that prepares a sample in accordance with the CLSI guidelines and an instrument that will process these samples in a manner that improves turnaround times while maintaining the lab’s quality of results.” Forthcoming from Siemens this year is at least one assay for the company’s CA-560, CA-1500, CA-7000, and BCS XP analyzers: the Innovance D-dimer, which will eventually replace Siemens’ Advanced D-dimer assay for assessing venous thromboembolic disease. “The assay is being developed to have excellent negative predictive value for deep vein thrombosis and pulmonary embolism,” Hauser says. “Also, this year we will be releasing Berichrom heparin calibrators and controls. These products will help laboratories improve their unfractionated heparin and low-molecular-weight heparin therapeutic monitoring, and have applications across our instrument base.”

“Easy to use, dependable, and reliable” are the watchwords at Diagnostica Stago, Wright says. He calls his company’s STA-R Evolution “the only coagulation analyzer that has the capability to connect to the majority of laboratory automation systems,” adding that it eliminates programming error via automatic uploading of the PT ISI, lot number, and expiration date in the reagents’ bar code. The STA-R Evolution also stores two calibration curves simultaneously, allowing users to manage several batches of reagents, and features 200 user-defined assays. Looking to the future of the market, Wright says, “There is a great deal of interest in using the heparin activated factor X test to monitor patients on heparin, both unfractionated and low molecular weight. A reliable measurement for monitoring heparin therapy, the heparin anti-Xa assay demonstrates more rapid achievement of anticoagulation goals, with fewer blood draws and dosage adjustments.” Finally, Michael Shiflett, president of American Labor, summarizes the state of affairs in the market by emphasizing that “the coagulation and hemostasis field continues to be one of phenomenal growth and potential for new and innovative test platforms.” However, he cautions, “There are still vast numbers of smaller and less demanding doctors’ offices, clinics, and small laboratories trying to deal with simple day-to-day decisions on how to get the quickest PT results for their patients—at a cost they can still make money at.”

CAP TODAY’s survey of coagulation analyzers includes systems from the aforementioned manufacturers. Vendors supplied the information listed. Readers interested in a particular analyzer should confirm that it has the stated features and capabilities.

Anne Ford is a writer in Chicago.