Sponsors of MRSA Diagnostics Should Define Cutoff Values

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for all outputs of the assay, including the cutoff value for defining negative and positive results, according to a new draft guidance. If an initial result requires retesting, the sponsor should recommend whether the test should be repeated from the same nucleic acid preparation, a new extraction or a new patient specimen, the FDA says.
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