College of American Pathologists
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  Coagulation analyzers—ready for routine and special assays


CAP Today




January 2011
Feature Story

Brendan Dabkowski

The companies in CAP TODAY’s coagulation analyzers product guide continue to develop systems that are easy to use, have more performance features, and—as personalized medicine moves forward—run increasingly specialized tests.

“In addition to routine testing needs,” says Tcoag marketing and product manager Kevin Mc­Glinch­ey, “coagulation laboratories continue to add more and more special coagulation assays to their testing menus.” As such, he says coagulation analyzers need to offer “a selection of methodologies and the flexibility that allow a laboratory to run all of these varied assays.” Diagnostica Stago’s director of marketing Bob Bachkosky says his customers are seeking assays related to personalized medicine applications and the development of new anticoagulants.

Two such in-demand tests are Stago’s STA Staclot DRVV Screen and STA Staclot DRVV Confirm lupus anticoagulant assays. Both tests are fully automated for use on the company’s STA family of hemostasis analyzers. New on the software side, says Bachkosky, is STA Coag ConneXion, an accessory for STA analyzers that provides expert rules for autovalidation, standardized data management, remote quality control, and comprehensive reports. Released in 2010 was Qualiris, a Web-based hemostasis proficiency testing program. It provides real-time peer group reports and monthly, biannual, and annual reports with quantitative and qualitative statistics. On the instrumentation side, still available are the Calibrated Automated Thrombogram, STA Satellite, STA-R Evolution Expert Series, Start, and STA Compact hemostasis system.

The latest at Tcoag—formerly Trinity Biotech—is the Destiny Max high-volume hemostasis platform, which was introduced in July 2009. The analyzer, says McGlinchey, performs chromogenic and immunoturbidimetric testing and allows users to choose optical or mechanical clot detection. The Destiny Max platform, he says, has a “unique design that allows the instrument to be linked to all the various track systems,” and it provides a closed-tube sampling technique that ensures proper volumes are pipetted and no microclots are aspirated. Also available for sale from Tcoag are the KC1, KC4, and Destiny Plus systems. (The company continues to support the Coag-A-Mate XM, Coag-A-Mate MTX, and MDA II systems.) McGlinchey predicts customers will demand of their coagulation analyzers complete traceability of results—which Destiny Max provides—as well as more automated features.

At Siemens Healthcare Diagnostics, the Innovance D-dimer assay, released in 2009, recently received FDA clearance for the exclusion of deep-vein thrombosis, reports Edi Rojas-Kenney, director of hemostasis, hematology, and urinalysis. The assay’s expanded use—it is also cleared for the exclusion of pulmonary embolism—is aimed at helping physicians provide timely diagnoses in high-risk and emergency care situations. It is available on the Sysmex CA-560, CA-1500, and CA-7000 automated coagulation systems as well as Siemens’ BCS XP platform. Rojas-Kenney notes customers are interested in how IT and informatics can improve laboratory efficiency, and this, in part, drove the development of an intelligent device management, or IDM, feature for the BCS XP system. IDM is an Internet-based service that allows company technicians to monitor system performance and operating status remotely and to correct potential problems.

Finally, available from Helena Laboratories are the Cascade M and Cascade M-4 coagulation analyzers, both of which were introduced in the early 1990s, and the AggRAM platelet aggregometer, released in 2005. The company, says global product manager of hemostasis/point of care Dave Pearman, will this year update its Cascade benchtop technology and expand its HemoRAM software, which serves the AggRAM. Helena will also this year launch a point-of-care coagulation analyzer with “a very broad coagulation platform,” he says. (Look for this in CAP TODAY’s May product guide to coagulation analyzers for use at the point of care.)

CAP TODAY’s guide to coagulation analyzers includes products from the aforementioned manufacturers and from American Labor/Lab ACM, Bio/Data Corp., Cepheid, Chrono-Log Corp., Instrumentation Laboratory/ Beckman Coulter, and LabiTec. Companies supplied the information listed. Readers interested in a particular product or system should confirm it has the stated features and capabilities.

Brendan Dabkowski is CAP TODAY associate editor.

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