经批准的指南——第二版承认定量分子方法在确定 患者体内的微生物浓度。CLSI文件MM06提供了开发和使用 定量分子方法，如核酸探针和靶序列的核酸扩增技术 针对特定微生物，并提出质量保证、能力验证和解释建议 结果如何。在诊断测试和监测中，尤其是在病毒性疾病中，核酸定量的具体问题包括 分子定量技术的最新进展；样本处理和准备；标准、校准器和参考 材料； 分析和临床验证/确认；报告和解释结果；临床应用；和建议 适用于制造商和临床实验室。

Approved Guideline--Second Edition recognizes the increased use of quantitative molecular methods for determining the concentration of microorganisms in patients. CLSI document MM06 provides guidance for the development and use of quantitative molecular methods, such as nucleic acid probes and nucleic acid amplification techniques of the target sequences specific to particular microorganisms, and presents recommendations for quality assurance, proficiency testing, and interpretation of results.Issues specific to the quantification of nucleic acid in diagnostic testing and monitoring, particularly in viral diseases, include an update on technologies used in molecular quantification; specimen handling and preparation; standards, calibrators, and reference materials; analytical and clinical verification/validation; reporting and interpreting results; clinical utility; and recommendations for manufacturers and clinical laboratories.