Blood Clotting Time Measured at POC

A hand-held, battery powered system provides a new PT/INR (Prothrombin Time, International Normalized Ratio, [clotting time]) point-of-care (POC) for non-waived anticoagulation services. Built-in controls and optional, external liquid controls ensure accurate PT/INR results for patients taking blood thinner medication.

Patients with atrial fibrillation or a mechanical heart valves require protection against thrombosis, or blood clots. They are typically put on lifelong oral anticoagulation therapy of Coumadin (warfarin) to thin their blood. It is imperative to monitor the therapeutic effects of anticoagulant medications as each patient reacts differently to them, and to keep potential risks at the lowest possible level.

Performing PT/INR testing at the point of care (POC) rather than at an outside lab allows healthcare professionals to make dosage adjustments and immediately advise patients, to help protect them from potentially serious complications. Using only a small 10 µl drop of blood obtained from a fingerstick, the CoaguChek XS plus system provides accurate, precise results in just one minute. Patient-preferred fingerstick testing with a POC device offers several benefits over traditional means of testing a venous blood sample, a process that can take up to several hours or even a few days, potentially delaying therapeutic decisions.

The new system has the ability to store up to 500 patient and or liquid quality control results that can be searched by patient, date and time. The meter also is designed for data management connectivity with patient ID, operator lockout, and quality control lockouts. The CoaguChek XS plus system performs two levels of onboard quality controls as part of every PT/INR test, all in a single test chamber, a feature designed to save time and provide enhanced confidence in the quality of results. The CoaguChek PT test strip also neutralizes therapeutic levels of heparin and low-molecular-weight heparin, enabling physicians to do POC testing on a broad range of anticoagulated patients.

The CoaguChek XS plus system was launched by Roche Diagnostics (Basel, Switzerland) and represents their fifth generation of point-of-care anticoagulation monitoring devices. The system is pending Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the U.S. Food and Drug Administration (FDA; Rockville, MD, USA).

"Coupled with a systematic anticoagulation management approach, the CoaguChek XS plus system can help physicians and laboratorians provide their patients with the current best practices in warfarin management,” said Randy Pritchard, director of strategic marketing for POC diagnostics at Roche Diagnostics. "That can help them increase their patients' time in therapeutic range, minimize adverse events, and address the new coagulation monitoring requirements in the Joint Commission's 2008 Patient Safety Goals.”


Related Links:
Roche Diagnostics
U.S. Food and Drug Administration