Roche Diagnostics announced that the FDA has granted CLIA-waived status to the CoaguChek® XS Plus system, a point-of-care anticoagulation monitor that offers connectivity and data management tools to help healthcare professionals manage PT/INR (blood clotting time) testing.
The waiver means that the monitoring technology may now be used in a broader range of clinical settings, such as labs that do not meet the requirements to do moderate- or high-complexity testing as defined by the Clinical Laboratory Improvement Amendments (CLIA) of 1988.
"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 Corporation. "The technology has several features that help ensure fast, accurate results, and the connectivity capabilities help healthcare providers with regulatory compliance and make it easier for them to manage their anticoagulation practices."
The CoaguChek XS Plus system works with the RALS-Plus information management system, which provides reporting and device management capabilities, to help hospital staff streamline the regulatory compliance process, capture reimbursable costs, and improve their organizational efficiency. In addition, recent enhancements to the system include the ability to hold up to 1000 patient results and the reduction of the sample size requirement to 8 microliters.
The CoaguChek XS Plus system uses two-level, built-in quality controls to help ensure the accuracy of PT/INR test results, but also offers optional liquid quality controls for facilities with policies requiring the use of external quality control measures.
Source: Roche Diagnostics