The Food and Drug Administration has granted CLIA-waived status to the Coaguchek XS Plus system from Roche Diagnostics.
The Coaguchek XS Plus system is 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 laboratories that do not meet the requirements to do moderate- or high-complexity testing as defined by the Clinical Laboratory Improvement Amendments (CLIA) of 1988.
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 organisational efficiency.
In addition, enhancements to the system include the ability to hold up to 1,000 patient results and the reduction of the sample size requirement to 8ml.
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.
