College of American Pathologists
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  POC coag technology path: simple to savvy


CAP Today




May 2011
Feature Story

Brendan Dabkowski

Smart businesses stick to the principle that the customer is always right. For manufacturers of point-of-care coagulation test systems, whose customers are often now individual patients, keeping that principle top of mind is imperative. Offering test systems that help ensure customers/patients are right—that is, in obtaining accurate coagulation status—protects lives.

“With the tremendous influx of patient self-testers, the patient is becoming the customer, in many cases, and the technology and delivery systems have to change to address that,” says Tim Huston, Roche Diagnostics’ director of marketing for professional diagnostics-physician office laboratory. Roche released in November a patient self-testing module of its Web-based CoaguChek Link application. The application enables anticoagulation patients enrolled with CoaguChek Patient Services, an independent diagnostic testing facility, to connect with their physicians to manage warfarin therapy and report and track prothrombin time/INR test results, Huston says. Patients can also use the self-testing module to order test supplies and update their online profiles. This summer, Roche will release an enhanced version of the clinic module of CoaguChek Link, which provides clinicians access to all of the necessary patient data in one place. With this tool, they can receive patient test results in real time, review the results online, and make dosage adjustments as necessary.

Roche launched last July its CoaguChek XS Pro system, which is designed for professional use. It measures PT/INR values in less than one minute with an 8-µL drop of capillary blood from a fingerstick. An integrated bar-code scanner allows for quick patient and operator identification, Huston says. Also available are the CoaguChek XS Plus system and CoaguChek XS system, the latter of which has a model available for patient self-testing, Huston notes.

The latest from Abbott Point of Care is the CoaguSense PT/INR monitoring system, which can be used in patients’ homes with a doctor’s prescription as well as in physician offices. Released in April 2010, the portable meter uses fresh capillary whole blood, non-anticoagulated venous whole blood, or recalcified citrated plasma, and directly detects clotting endpoint, says product manager Doug Gavin. Testing with non-anticoagulated venous whole blood or recalcified citrated plasma samples should be performed by moderate-complexity laboratories, he notes. The system requires a 10-µL-sized blood sample and reads and displays results in less than one minute. For control purposes, it offers high and low control strips, which contain the same thromboplastin used in the patient test strip along with plasma of known INR, Gavin says.

Abbott expects to launch later this year the i-Stat 1 wireless system, a new version of the i-Stat bedside point-of-care testing device that has been on the market since 2001. The i-Stat 1 wireless handheld recently received FDA 510(k) clearance and is designed to allow real-time transmission of test results directly from the patient bedside, says Sara Scibal, global product manager for acute care.

Soon to join Helena Point of Care’s lineup—which consists of the Actalyke XL, Actalyke Mini II, and Cascade POC analyzers—is a next-generation version of the Cascade POC system for hemostasis/thrombosis. Slated for release next month, the new version is a handheld unit about half the size of its predecessor, says global marketing manager for hemostasis/POC divisions Dave Pearman, who adds that its features include more connectivity options, a larger test menu, and a color touchscreen. “POC coagulation has come a long way over the years from crude attempts to savvy, enabling technology,” he says. “I have been in this sector for 20 years, and ‘lab-like,’ which was a dream adjective in the beginning, is coming closer and closer to reality now.” Pearman predicts that point-of-care coagulation testing, fueled by new anticoagulants and savvy technology, will continue its upswing.

CAP TODAY’s point-of-care and self-monitoring coagulation analyzers product guide includes instruments from the aforementioned companies, as well as Alere, ITC Nexus Dx, and Medtronic Cardiac Surgery. Readers interested in a particular product should confirm it has the stated features and capabilities.

Brendan Dabkowski is CAP TODAY associate editor.

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