This guideline describes currently used analytical approaches and methodologies applied to identify the clinically important genetic characteristics responsible for disease manifestation, outcome, and response to therapy in the infectious disease setting. It also provides guidance on the criteria to be considered for design, validation, and determination of clinical utility of such testing.
CLSI MM10-A
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Genotyping for Infectious Diseases: Identification and Characterization; Approved Guideline, MM10AE
Clinical and Laboratory Standards Institute , 02/17/2006