College of American Pathologists
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  In coagulation, the push continues for more
  and better


cap today



January 2007
Feature Story

Anne Ford

In the view of Venita C. Shirley, Beckman Coulter marketing manager for hemostasis instruments, three of the most important questions that laboratories must answer about patients relate to coagulation: “Are they bleeding? Are they going to clot? Or are they okay?”

“If you look at the different disciplines in the lab—the chemistry, the hematology,” she adds, “they get tons and tons and tons more samples than the coag lab, but if you look at what results are the most important, the critical results are really the ones coming from coag.” Thats why, she confesses, “I get pretty excited about it.” This month’s instrumentation survey, which focuses on coagulation analyzers, offers much for coag customers to get excited about as well.

At Dade Behring, the word is “connectivity.” To consolidate high-volume coagulation and clinical chemistry testing, in the third quarter of 2006 the company introduced an automated connection between its Sysmex CA-7000 analyzer and StreamLab analytical workcell. Marketing manager Jackie Hauser reports: “The StreamLab system features an open-architecture design, which provides customers with the ability to connect multiple Dimension chemistry systems, third-party immunoassay systems, and a high-speed coagulation system.” This open architecture, she says, lets customers “build a configuration customized to meet the unique needs of their own laboratory, and provides effective and economical solutions for space limitations, high test volumes, limited staff, and budget constraints.” In addition, Dade Behring plans to introduce a middleware product with coag analyzer connectivity; the product “may assist the lab in automating result verification as well as simplifying QC processes.” The company manufactures the recently introduced BCS XP specialty analyzer system, which offers clotting, chromogenic, and immunologic methodologies, as well as user-customizable software features and a research-use-only endogenous thrombin potential assay.

Two companies offer, or will offer, lupus assays. Diagnostica Stago plans to introduce its STA StaClot DRVV screen and confirm test soon; the company’s StaClot LA assay, which uses the hexagonal phase phospholipids, is already available. And Beckman Coulter provides two lupus assays: the HemosIL silica clotting time, or SCT, screen and confirm kit and the HemosIL LAC screen and confirm kit. The SCT assay uses phospholipids sensitized to lupus anticoagulant to activate the intrinsic pathway, while the LAC assay uses diluted Russell’s viper venom to activate the common pathway. Those differing functionalities, Shirley says, are a response to the International Society on Thrombosis and Haemostasis lupus anticoagulant guidelines, which recommend that laboratories use more than one test before excluding a lupus anticoagulant.

Also forthcoming from Diagnostica Stago is the STA Liatest FM, a research-use-only automated quantitative assay for soluble fibrin monomer complexes, or SFMC. “This is the first and only automated test for SFMC in the U.S.,” says product manager Karen Wrona. “It is in the final stages of development.” Additional research-use-only parameters include ELISAs for thrombin activatable fibrinolysis inhibitor and antiphospholipid antibodies. Another research-use-only Diagnostica Stago offering: the Calibrated Automated Thrombogram, or CAT, assay, which the company distributes in the United States on behalf of Biodis. “The CAT utilizes the latest in a series of technological breakthroughs for the measurement of thrombin generation in plasma,” Wrona says. The company also distributes Biodis’ Rotem, a whole blood thromboelastograph that provides what Wrona calls a “comprehensive diagnosis of hemostatic disorders.” 510(k) submission for the Rotem is pending. Diagnostica Stago is the maker of the recently introduced STA-R Evolution analyzer for large-volume laboratories, which Wrona calls “unique in its ability to connect to all existing lab automation and/or robotic lines.”

Last year saw three new analyzers from Beckman Coulter, namely, the Elite, Elite Pro, and ACL Top CTS. Shirley calls the latter “the biggest one of the bunch.”

“It’s a high-end instrument designed for the high-volume laboratories,” she says.

The analyzer has a cap-piercing option, and while cap-piercing has been available for some time, “it’s not been reliable,” in Shirley’s view. “We waited [to offer cap-piercing] until we had the technology that allows it to be reliable and robust. The ACL Top CTS also offers our customers connectivity to sample processing automation with Beckman Coulter’s laboratory automation.”

Meanwhile, the Elite is aimed at low-volume laboratories, while the Elite Pro serves labs with low to moderate test volumes. “The Elites are the first instruments of their class to offer reagent bar coding,” says Shirley. In addition, “they feature LED clot detection technology, which actually measures at a wavelength past the area where interference causes problems. Interference usually will cause problems below 600. So we read out past 600, and because of that our customers are able to report out results.”

Brooke McCutchan, MT(ASCP), Trinity Biotech hemostasis marketing manager, reports that 2007 will bring an addition to the company’s Destiny hemostasis instrument family. The new instrument will be the largest of the Destiny platforms and will feature cap-piercing and enhanced software. The most recently introduced Destiny instrument, the Destiny Optical, was launched in the second quarter of 2006. “It is an optical-only system that promotes half-volume testing and a comprehensive test menu, including automated D-dimer, and offers a throughput of 107 PT per hour,” McCutchan says.

CAP TODAY’s survey of coagulation analyzers includes systems from the aforementioned manufacturers and from American Labor/Lab ACM, Thermo Scientific, and Helena Laboratories. 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.