CLSI MM03
Molecular Diagnostic Methods for Infectious Diseases
Organization: | CLSI |
Publication Date: | 1 February 2015 |
Status: | active |
Page Count: | 110 |
scope:
This document 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
- QA
- Regulatory issues
- Recommendations for manufacturers and clinical laboratories
This document 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/characteri
This document should be used in conjunction with the following related CLSI documents: MM06,3 MM09,4 MM10,5 MM13,6 MM14,7 MM17,8 and MM19.9
Document History

