This guideline addresses topics relating to clinical applications, amplified and nonamplified nucleic acid methods, selection and qualification of nucleic acid sequences, establishment and evaluation of test performance characteristics, inhibitors, and interfering substances, controlling false-positive reactions, reporting and interpretation of results, quality assurance, regulatory issues, and recommendations for manfactuers and clinical laboratories.

CLSI MM03A2
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Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline, MM03-A2
Clinical and Laboratory Standards Institute , 02/17/2006