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Cepheid's Xpert MRSA test helps detect HAI cases

Cepheid : 22 May, 2007  (New Product)
The US Food and Drug Administration (FDA) has categorised Cepheid's Xpert MRSA test for the rapid detection of of Methicillin-Resistant Staphylococcus aureus as 'Moderate Complexity'.
The FDA categorised the test under the Clinical Laboratory Improvement Amendments (CLIA).

Cleared for marketing by the FDA in April 2007, Xpert MRSA is the first molecular diagnostic MRSA test to receive the moderate complexity CLIA categorisation.

With this designation, Xpert MRSA is now available for use both within and outside of the traditional laboratory setting of the approximate 4,000 hospitals in the USA.

'The implementation of MRSA surveillance programmes is demonstrating effectiveness in reducing hospital acquired infections (HAI) thereby improving patient welfare and reducing the significant cost associated with HAI', said Cepheid chief executive officer John Bishop.

The GeneXpert System is enabling 'on demand testing' and reducing the time from the point at which the patient specimen is taken until the result is returned to the hospital floor to as little as two hours' 'With the Moderate Complexity categorisation of Xpert MRSA, hospitals will have increased flexibility as to deploying the system for maximum patient benefit and cost benefit'.

Cepheid is currently working with a broad range of healthcare organizations in the public and private sector to initiate MRSA surveillance programmes.

Included in this group are the Veterans Health Administration (VHA) facilities that must comply with a system wide directive to implement mandatory MRSA surveillance of all patients, implementing molecular diagnostics whenever possible.

To date Cepheid has been selected for utilisation by ten VA Medical Centers and is under consideration at an additional 37 VA Medical Centers.

'Our goal is to screen all patients entering our hospital to determine their risk of carrying MRSA, and then conduct a swab test on all high risk patients', said Beverly Sturgill, Infection control officer for Carilion Roanoke Memorial Hospital in Roanoke, Virginia.

'With Xpert MRSA we are able to get results back within two hours, 24 hours a day, seven days a week'.

'This makes it possible for us to begin contact precautions quickly, improving our ability to prevent transmission'.

Running on Cepheid's GeneXpert System, the Xpert MRSA test delivers results in just over one hour, enabling healthcare organizations the ability to rapidly identify MRSA carriers and implement the proper Infection control measures to lower hospital acquired infection rates and improve patient care.
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