Laboratories have made known what they need from coagulation instruments, and diagnostics companies have heard you loud and clear.
“Automation of manual tasks will remain the driving force behind the design of coagulation analyzers and assays,” says Venita Shirley, MBA, MT(ASCP), Beckman Coulter’s hemostasis market manager. As testing volumes rise, customers continue to want “ease of use and a minimal number of manual steps,” she says. “Overall,” says Kevin McGlinchey, MT(ASCP), CLS(CG), Trinity Biotech hemostasis marketing manager, “automated coagulation analyzers need to offer multiple methodologies, have low operating costs, be easy to use, and produce accurate and reliable results.” Beyond that, adds Larry Wright, Diagnostica Stago instrument product manager, “there is a requirement for standardization across instrument platforms.”
These things and more are what the companies in this month’s instrumentation product guide are aiming to deliver.
New from Beckman Coulter/Instrumentation Laboratory is the ACL TOP 500 Closed Tube Sampling hemostasis analyzer, released in July 2008. “Equipped with LED-based clot detection that reads clot-based assays at 671 nm, and with a throughput of up to 240 tests per hour and the ability to operate continuously, 24/7, the ACL TOP 500 offers coag testing that is fast, efficient, and high-quality,” Shirley says. Designed for mid- to high-volume laboratories, the instrument reports prothrombin time results in three minutes and features software that can streamline numerous tasks. The analyzer “helps labs maximize labor resources, reduce turnaround time, and improve patient care,” she says, by providing clotting as well as chromogenic and immunoturbidimetric testing capabilities, with a complete menu of routine and specialty assays.
Trinity Biotech’s McGlinchey says developers of automated coagulation analyzers and methods will need to keep pace by introducing new technologies that can meet the needs of all coagulation labs, regardless of size. “There will be an increased need to supply a family of instrumentation that can create true standardization for a group of regional or national laboratories or a group of instruments in a single laboratory,” he says. To this end he offers up the company’s Destiny family of instruments, which includes the Destiny Plus and, for high-volume labs, the new Destiny Max. To be released early this year, the Destiny Max will offer users the ability to perform mechanical or optical clot detection and provide cap-piercing capability and a calibration system for PT and PTT, known as TriniVeriCal. The analyzer will have the capability to link to various automated lab systems and a complete test menu so it can meet the needs of routine and esoteric coagulation laboratories, McGlinchey says.
New from Diagnostica Stago is the Star Evolution Expert series analyzer for mid to high volume laboratories, which received FDA clearance in October 2008. The analyzer simultaneously tests for clotting, chromogenic, and immunologic assays, providing high throughput of routine and coagulation specialty assays, Wright says. Its features incorporate Windows XP software to optimize sample management and provide optimum security and complete traceability of patient results, he says. Also included: a comprehensive QC program, new dedicated certification/ accreditation features, and computer specifications as well as a built-in CD/DVD burner and USB ports.
Also new from Diagnostica Stago is the recently FDA-cleared Sta Satellite, an automated benchtop analyzer that simultaneously performs clotting, chromogenic, and immunologic assays. “The Sta Satellite offers complete automation to the low-volume coagulation laboratory,” Wright says. “It is an optimal choice for groups with satellite labs, enabling systemwide standardization with all of the analyzers of the Sta line.” It can run PT, APTT, fibrinogen, D-dimer, antithrombin, and heparin anti-Xa with 20 onboard sample positions and stat capability.
In conjunction with Instrumentation Laboratory, this year Beckman will offer Xpert HemosIL FII and FV (currently in development), “the first fully integrated, real-time PCR for FII G20210A and FV Leiden genotyping,” Shirley says. Beckman also plans to release this year a liquid heparin assay to simplify the monitoring of heparin therapy. Shirley’s predictions for the coag market’s future: Coagulation laboratories will not only screen for and diagnose thrombotic/bleeding disorders and monitor anticoagulant therapy, but they will be proactive in determining if individuals are predisposed for thrombophilia.
Bio/Data Corp.’s newest offering is specialized software for its PAP-8E platelet aggregation profiler, which was released in 2006. The software, introduced last year, adds “clinical trial-specific procedures, sample time bases, site validation and control functions, and hardened data collection” to the analyzer, says Bio/Data vice president William M. Trolio, CLS(NCA). The company also unveiled a performance verification kit for the PAP-8E, specimen collection kits, and study-specific agonists. Introduced in 2007 was the PDQ platelet function centrifuge, a companion product to the PAP-8E.
Finally, Helena Laboratories’ newest instrument is Cascade POC, which was introduced last year. (You will find this device not in this issue but in CAP TODAY’s May product guide to coagulation analyzers for use at the point of care and for self-monitoring.) The point-of-care analyzer uses disposable test cards and reads results by way of a photo-mechanical system based on a fibrin endpoint, says James Campbell, MT(ASCP), MPH, consultant to Helena’s point-of-care/hemostasis division. Cascade POC offers a fresh whole blood PT, a citrated whole blood/plasma PT, a citrated whole blood/plasma APPT, and a fresh whole blood Celite-equivalent ACT. Other test card systems in development for use on the Cascade POC are low-molecular-weight heparin, direct thrombin inhibitors, fibrinogen, and heparin/protamine titrations. A bar-code reader will be added.
CAP TODAY’s product guide (PDF, 1.1 MB) to coagulation analyzers, includes analyzers from the aforementioned manufacturers as well as Siemens Healthcare Diagnostics and American Labor. Companies supplied the information listed. Readers interested in a particular analyzer should confirm it has the stated features and capabilities.
Brendan Dabkowski is CAP TODAY associate editor.