本文件提供了作为多重分子测试分析物的核酸质量评估的术语和一般要求，多重分子测试同时识别两个或多个感兴趣的核酸靶序列。本文件适用于使用体外诊断（IVD）医疗设备和实验室开发测试（LDT）进行检查的所有多重分子方法。它为核酸靶序列的定性和定量检测提供信息。 本文件旨在为检测和/或量化人类临床标本中的人类核酸靶序列或微生物病原体核酸靶序列的多重分子分析提供指导。本文件适用于医学实验室进行的任何分子体外诊断检查。它也适用于实验室客户、体外诊断开发商和制造商、生物银行、从事生物医学研究的机构和商业组织以及监管机构。 本文件不适用于宏基因组学。 注:为实验室自身使用而开发的检查程序通常被称为“实验室开发测试”、“LDT”或“内部测试”。

This document provides the terms and general requirements for the evaluation of the quality of nucleic acids as the analytes for multiplex molecular tests, which simultaneously identify two or more nucleic acid target sequences of interest. This document is applicable to all multiplex molecular methods used for examination using in vitro diagnostic (IVD) medical devices and laboratory developed tests (LDTs). It provides information for both qualitative and quantitative detection of nucleic acid target sequences. This document is intended as guidance for multiplex molecular assays that detect and/or quantify human nucleic acid target sequences or microbial pathogen nucleic acid target sequences from human clinical specimens. This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. This document is not applicable to metagenomics. NOTE An examination procedure developed for a laboratory's own use is often referred to as a "laboratory developed test", "LDT", or "in-house test".