RT-PCR Assay Detects MRSA Nasal Colonization

A qualitative real time PCR (RT-PCR) in vitro diagnostic test, which detects methicillin-resistant Staphylococcus aureus (MRSA) nasal colonization, will aid in the prevention and control of MRSA infections in hospitals and other health care settings.

Samples for testing are obtained using nasal swabs. The Detect-Ready ready-to-use premixed reagents require only the addition of patient sample to run the assay, which provides test results in one to two hours. Unlike other testing products that require special handling, Detect-Ready kits are off-the-shelf room temperature-stabilized and require no refrigeration.

The Detect-Ready MRSA Kit, shortly to be launched by Molecular Detection Inc., (Wayne, PA, USA; and Jerusalem, Israel) is a qualitative real time polymerase chain reaction PCR (RT-PCR) in vitro diagnostic test for the direct detection of MRSA nasal colonization. It will help prevent and control of MRSA infections in hospitals and other health care settings.

Ready-to-use premixed reagents require only the addition of patient sample to run the assay, which provides test results in one to two hours. Unlike other testing products that require special handling, Detect-Ready kits are off-the-shelf room temperature-stabilized and require no refrigeration.

Detect-Ready kits are compatible with multiple RT-PCR platforms currently found in clinical laboratories. The flexibility to leverage existing infrastructure and equipment to run Detect-Ready assays eliminates the need for additional hospital capital investment.

The Detect-Ready MRSA assay kit has received CE marking certification for sales in the European Union. It will be launched in Europe in late 2009, with U.S. regulatory clearance expected in 2010.

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Molecular Detection