The CoaguChek XS Plus system uses two-level, built-in quality controls to help ensure the accuracy of prothrombin time/international normalized ratio (PT/INR) test results. It also offers optional liquid quality controls for facilities with policies requiring the use of external quality control measures.

Roche Diagnostics (Indianapolis, IN, USA), part of the Roche Group (Basel, Switzerland), announced that the U.S. Food and Drug Administration (FDA; Silver Springs, MD, USA) granted Clinical Laboratory Improvement Amendments (CLIA)-waived status to its CoaguChek XS Plus system. The CoaguChek XS Plus system works with the RALS-Plus information management system, which provides reporting and device management capabilities. Recent enhancements to the system include the ability to hold up to 1,000 patient results and the reduction of the sample size requirement to eight mL.

"With the waiver for the CoaguChek XS Plus system, healthcare professionals in CLIA-waived environments will now have access to new tools and connectivity options to help them manage patients on warfarin therapy," said Tim Huston, director of marketing, professional diagnostics-physician office laboratory at Roche Diagnostics.

The CoaguChek XS Plus system, which provides results in about a minute and has a 97% correlation to lab analyzer results, represents the fifth generation of point-of-care anticoagulation monitoring devices from Roche Diagnostics.

Roche Diagnostics offers a broad range of diagnostic tests and systems that play a central role in the area of integrated healthcare solutions. Its products cover the early detection, targeted screening, evaluation, and monitoring of the disease.

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