Roche Diagnostics' newly launched
CoaguChek XS Plus System offers built-in controls and optional, external
liquid controls to help non-waived clinics monitoring anticoagulation
ensure accurate PT/INR (clotting time) test results for patients taking
blood thinner medication.
The handheld, battery-powered CoaguChek XS Plus 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 is pending CLIA waiver approval by the
Food and Drug Administration.
"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 Point of Care
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."
Similar to the CoaguChek XS System using the CoaguChek XS PT Test
Strip, 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 point-of-care testing on a broad range of anticoagulated
patients. The latest CoaguChek system, with the use of the CoaguChek PT
test strip, continues to provide accurate, precise results in just one
minute from a small 10 microliter drop of blood obtained from a
fingerstick, increasing patient comfort.(1)
The optional external liquid quality controls available as the
CoaguChek XS Plus PT Controls include a code chip and eight bottles of
liquid quality controls (four level 1 bottles and four level 2 bottles)
that allow laboratorians to independently test the CoaguChek XS Plus
System.
Performing PT/INR testing at the point of care rather than at an
outside lab allows healthcare professionals to make dosage adjustments and
talk with patients immediately, to help protect the patients from
potentially serious complications. Patient preferred fingerstick testing
with a POC device offers several benefits over testing with a venous blood
sample, a process that can take up to several hours or even a few days,
potentially delaying therapeutic decisions.(1)
About Anticoagulation Monitoring
Patients with atrial fibrillation or a mechanical heart valve require
protection against thrombosis, or blood clots. They are typically put on
life- long oral anticoagulation therapy of Coumadin(R) (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.
About CoaguChek products
Physicians have been using CoaguChek instruments for POC PT/INR testing
since 1994. Today, in the U.S., more PT/INR tests at the point of care are
done using the CoaguChek family of products than any other device on the
market.(2) The CoaguChek XS Plus represents the fifth generation of
point-of- care anticoagulation monitoring devices from Roche Diagnostics.
About Roche and the Roche Diagnostics Division
Headquartered in Basel, Switzerland, Roche is one of the world's
leading research-focused healthcare groups in the fields of pharmaceuticals
and diagnostics. As a supplier of innovative products and services for the
early detection, prevention, diagnosis and treatment of diseases, the Group
contributes on a broad range of fronts to improving people's health and
quality of life. Roche is a world leader in diagnostics, the leading
supplier of drugs for cancer and transplantation and a market leader in
virology. In 2006, sales by the Pharmaceuticals Division totaled 33.3
billion Swiss francs, and the Diagnostics Division posted sales of 8.7
billion Swiss francs. Roche employs roughly 75,000 people in 150 countries
and has R&D agreements and strategic alliances with numerous partners,
including majority ownership interests in Genentech and Chugai. Roche's
Diagnostics Division offers a uniquely broad product portfolio and supplies
a wide array of innovative testing products and services to researchers,
physicians, patients, hospitals and laboratories world-wide. For further
information, please visit our U.S. Web site at roche-diagnostics.us.
All trademarks used or mentioned in this release are legally protected
by law.
References
(1) Giles TD and Rofidal L. Results of the prothrombin office testing
benefit evaluation (PROBE), Cardiovascular Review and Reports. Vol
XXIII, No. 1, January 2002.
(2) Second Quarter 2007 total market share of projected distributor unit
sales of the Point of Care Testing Coagulation Reagents and Kits
product class by HPIS Market Intelligence, a division of GHX Global
Healthcare Exchange. Total Market includes all market sectors as
defined by HPIS. Physician, Long Term Care, Treatment Centers,
Clinical Laboratory, Hospital, Home Healthcare and Other/Unspecified.
Data on file at Roche Diagnostics.
Roche Diagnostics
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View drug information on Warfarin Sodium tablets.