Coagulation analyzers:
New analyzers, assays, controls, and PEP

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Anne Ford

January 2014—With the new year come fresh offerings from coagulation analyzer manufacturers, of which at least two have launched entirely new testing systems.

Instrumentation Laboratory’s ACL AcuStar hemostasis system has been “met with great enthusiasm for its speed, accuracy, and comprehensive line of high performance chemiluminescent assays,” says Venita C. Shirley, director of marketing for commercial operations in North America. The system, which she terms “the first hemostasis analyzer to incorporate chemiluminescence technology,” features the HemosIL AcuStar anticardiolipin (IgG and IgM) and anti-β2GP-I (IgG and IgM) assays for antiphospholipid syndrome.

Also new from the company are the HemosIL protein S activity and factor VIII assays. The first, a second-generation assay, offers increased onboard stability of eight hours on ACL TOP systems, while the second is a factor VIII-deficient plasma that features 24-hour stability. In addition, “Instrumentation Laboratory is working toward the release of several new assays in the United States,” Shirley says. Those include HemosIL VWD:RCo Activity and HemosIL HIT-Ab(PF4-H), both already available in Europe and Canada.

Fresh from Diagnostica Stago: the STA Compact Max benchtop analyzer, “suitable for use in routine and specialty hemostasis testing,” says marketing director Hamid Erfanian. “It combines powerful and proven viscosity-based clot-detection technology with easy-to-use expert module software.” Innovative features of this new instrument’s software, he adds, are multi-dilution management for factor assays; electronic lot conversion; autoverification rules; automatic management of dilutions, reruns, and reflex testing; advanced USB export capabilities; and customizable database queries.

This launch, Erfanian says, will be followed in the first quarter of this year by the STA-R Evolution Plus, a high-volume instrument-software combination that will perform simultaneous clotting, chromogenic, and immunological assays. In a manner similar to the new STA Compact Max, “the STA-R Evolution Plus provides enhanced software capabilities to allow users to manage patient results with autovalidation, delta check, and the ability to incorporate expert rules to perform multi-dilution factor testing,” he says. “QC management features include Levey-Jennings graphs and value tables as well as Westgard rules and instant access to up to 500,000 archived patient results.”

He adds that early 2014 should also see the launch of the STA Coag Control N and ABN Plus 24-hour controls for use with Stago’s clotting assays for prothrombin time, activated partial thromboplastin time, fibrinogen, and thrombin time, with added values for the chromogenic antithrombin assay. Finally, forthcoming for research use only are the STA–Apixaban calibrator and controls, which Erfanian calls “highly specific, automation-ready products for determining the apixaban concentration in plasma,” as well as dabigatran calibrators and controls for measuring direct thrombin inhibitors using the Ecarin Chromogenic Assay.

Bio/Data, meanwhile, marks the new year with not an introduction but a reintroduction—that of its non-activated partial thromboplastin time reagent, known as UPTT. “UPTT is used to perform required tests for evaluating hemocompatibility on medical devices that have in vivo contact with blood, regardless of how short the contact interval is,” explains William M. Trolio, vice president and CSO. He adds that the UPTT has been formulated to meet an ANSI/ISO biocompatibility guideline specifying that a test with established sensitivity to the degree of activation of the intrinsic coagulation pathway be used in the development and pre-approval clinical tests of a medical device.

In his view, three paradigm shifts are underway in platelet studies. “Studies of platelet structure and function at the molecular and sub-molecular level are yielding new insights that may point the way to longer term storage of functional platelets for transfusion and improved applications for PRP therapy,” he says. “In addition, potential targets for new therapeutic agents are being identified and studied. The search for new antiplatelet agents that can be tailored to individual needs and whose effect can be reversed follows along the same trajectory.”

Finally, Siemens has developed an education solution it calls the Personalized Education Plan, or PEP. “For example, this past year we introduced on-demand webinars related to coagulation testing, and this series will continue with new topics in the coming months,” hemostasis marketing director Jackie Hauser says. “We are also adding new instrument-based courses that integrate online and in-person training to help operators achieve the necessary competencies to ensure laboratory quality. In addition, PEP Administrator is available to support customer compliance needs by providing the visibility, administration, and reporting tools to ensure educational competence, quality, and compliance verification throughout the entire organization.”

CAP TODAY’s guide to coagulation analyzers includes products from the aforementioned manufacturers and from American Labor/Lab A.C.M., Chrono-Log, Helena Laboratories, and LABiTec. Companies supplied the information listed. Readers interested in a product should confirm it has the stated features and capabilities.n
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Anne Ford is a writer in Evanston, Ill.