May 24, 2011
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FDA clears molecular MRSA test
The FDA has granted clearance for an automated molecular test for screening methicillin-resistant Staphylococcus aureus, according to a press release.
BioMerieux announced that its NucliSENS EasyQ test received clearance after achieving clinical sensitivity of 94.7% and clinical specificity of 96.5% when testing nasal samples of adult patients. The sensitivity was 100% and the specificity was 97.3% for nasal samples from children.
The test detects seven of the most common MRSA strains by simultaneously detecting two targets. The system has the capacity to support batch processing of up to 46 MRSA screening tests in a compact space within a 3-hour period.
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