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Home » Sponsors of MRSA Diagnostics Should Define Cutoff Values
Sponsors of MRSA Diagnostics Should Define Cutoff Values
January 19, 2011
Sponsors of nucleic acid-based in vitro diagnostics (IVDs) intended to detect Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) should indicate the cutoff values for all outputs of the assay, including the cutoff value for defining negative and positive results, according to a new draft guidance.