College of American Pathologists
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  What’s new and what’s next for coagulation analyzers


CAP Today




January 2010
Feature Story

Brendan Dabkowski

As the decade was coming to an end, marketers of coagulation analyzers released last year new products to help hematology laboratories automate processes and better serve patients for years to come.

“Instruments that automate complex testing steps and provide a test menu with sensitive assays that feature robust reagent stability will drive the future of hemostasis testing,” says Venita Shirley, Beckman Coulter’s hemostasis market manager. Kevin McGlinchey, hemostasis marketing manager at Trinity Biotech, concurs. The universal trend of needing to do more with less “creates an increased need for automation at every stage of the laboratory testing process,” and new high-volume hemostasis analyzers must address this need, he says.

One instrument doing so is Trinity Biotech’s Destiny Max hemostasis analyzer, which is suited for high-volume routine and specialty testing laboratories. Released in July 2009, the multipurpose automated random-access analyzer performs mechanical, optical, chromogenic, and immunoturbidimetric analysis, McGlinchey says. Destiny Max provides cap piercing and complete traceability of results, and it comes with an intuitive touchscreen and easy-to-use software. The company also offers a calibration product called TriniVeriCal, which normalizes the prothrombin time and partial thromboplastin time ranges from one analyzer to the next or from one hospital to another, he says.

Among Instrumentation Laboratory/Beckman Coulter’s latest offerings is the ACL TOP 700 LAS analyzer, which automates hemostasis testing, Shirley says. Launched in April 2009, the ACL TOP 700 features a “point-in-space” arm that samples directly from the automation line as well as a standard sample arm. The instrument offers priority sample management, allowing labs to obtain PT results in three minutes. It has a throughput of 360 PTs per hour, onboard sample capacity of 90, and reagent capacity of 60 and handles up to 500 test applications. The analyzer, Shirley adds, comes with intuitive software and a reagent management system that uses a two-dimensional bar code to import lot-specific values, including calibration, assayed control, and PT international sensitivity index values.

Also new are the HemosIL liquid heparin monitoring system and Xpert HemosIL factor II and factor V test, both of which are marketed by Beckman Coulter. The liquid heparin monitoring system simplifies the process of measuring different types of heparin, says Shirley, while the factor II and factor V test provides factor V Leiden and factor II prothrombin G20210A results in 30 minutes.

This month Bio/Data Corp. is upgrading its eight-channel Platelet Aggregometer, the PAP 8E, with new software, says William M. Trolio, vice president of Bio/Data. The enhanced software will allow the aggregometer to better measure platelet aggregation in samples previously flagged as compromised. And in February, Bio/ Data will release an instrument performance verification kit and QC package for light transmission aggregometry, or LTA. The package, called LTA Check, will verify and document analyzer performance before the instrument is used for patient testing, he says.

Siemens Healthcare Diagnostics introduced last year the Innovance D-dimer assay, which is available on the BCS/BCS XP as well as the Sysmex CA-560, CA-1500, and CA-7000 automated coagulation systems. The assay, says Jackie Hauser, the company’s senior marketing manager for hemostasis, allows “labs of all sizes the opportunity to efficiently perform D-dimer testing in their coagulation departments.” It recently received clearance for diagnostic exclusion of pulmonary embolism, she adds.

Siemens also released in 2009 its Innovance antithrombin assay, which adds to laboratories’ arsenal of thrombosis-risk tests. Through its partnership with Sysmex Corp., Siemens is readying for market the CS-2000i and CS-2100i systems, which are designed to maximize efficiency, minimize costs, and save technologists’ time, while focusing on preanalytical sample integrity. Both systems, says Hauser, will be offered with and without a cap-piercing option.

American Labor/Lab ACM released in December the CoaData 2004 and CoaData 4004 systems. The 2004 is a two-channel analyzer, while the 4004 is a four-channel analyzer.

Finally, Chrono-Log Corp. continues to market its Whole Blood-Optical Lumi-Aggregation System 700, which was introduced in 2005. According to sales coordinator Kathy Jacobs, the device measures platelet aggregation and secretion simultaneously in four samples at a time.

CAP TODAY’s coagulation analyzers product guide includes instruments from the aforementioned manufacturers, as well as from Cepheid, Diagnostica Stago, and Helena Laboratories. 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.