本归档文件不再通过CLSI共识文件开发流程进行审查。然而，本文件自2020年1月起在技术上有效。由于它对实验室社区的价值，它被保留在CLSI的图书馆中。用于检测和表征临床标本中微生物的核酸方法现在已在实验室医学中牢固确立。这些方法为临床实验室提供了提供更快速和准确结果的机会，并改变了临床微生物学和传染病的实践。临床和实验室标准协会文件MM03《传染病分子诊断方法》阐述了与临床应用、扩增和非扩增核酸方法、核酸序列的选择和鉴定、测试性能特征的建立和评估、抑制剂和干扰物质、控制假阳性相关的主题- 积极反应、结果报告和解释、质量保证、监管问题，以及对制造商和临床实验室的建议。

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid as of January 2020. Because of its value to the laboratory community, it is being retained in CLSI's library.Nucleic acid methods for the detection and characterization of microorganisms in clinical specimens are now firmly established in laboratory medicine. These methods offer opportunities for clinical laboratories to provide more rapid and accurate results, and have changed the practice of clinical microbiology and infectious diseases. Clinical and Laboratory Standards Institute document MM03—Molecular Diagnostic Methods for Infectious Diseases 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, QA, regulatory issues, and recommendations for manufacturers and clinical laboratories.