scope:

This guideline describes general principles for the development, evaluation, and application of tests designed for direct detection of microorganisms in clinical specimens and for identification of microorganisms grown in culture. The document provides evidence-based recommendations, where appropriate. The following content areas are addressed: 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 manufacturers and clinical laboratories.

This guideline is intended for use by clinical laboratories, test developers and manufacturers, and regulatory agencies. It is not intended to be a compilation of successful protocols for detection/characterization of microorganisms, but rather to describe general principles for the development, evaluation, and application of these tests. The readers are directed to the Manual of Clinical Microbiology, 8^th edition, and Molecular Microbiology: Diagnostic Principles and Practice from ASM Press, Washington, DC, for more information on specific applications.

This guideline should be used in conjunction with the most current editions of the following related CLSI/NCCLS documents: MM6-Quantitative Molecular Methods for Infectious Diseases; MM9- Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; MM10-Genotyping for Infectious Diseases: Identification and Characterization; MM13-Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; and MM14-Proficiency Testing (External Quality Assessment) for Molecular Methods.