标准摘要
[中文适用范围]： 本文件给出了多联分子检测同时识别两个或多个感兴趣核酸靶序列的解释和报告的基本要求。 本文件适用于体外诊断（IVD）医疗器械和实验室自建检验（LDTs）中所有多联方法用于检查。 [外文原描述]： This document gives the general requirements for interpretation and reporting of multiplex molecular tests which simultaneously identify two or more nucleic acid target sequences of interest. This document is applicable to all multiplex 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 examinations that detect or quantify human nucleic acid target sequences and microbial pathogen nucleic acid target sequences from human clinical specimens. This document is applicable to any molecular IVD examination performed by medical laboratories. It is also intended to be used by laboratory customers, IVD developers and manufacturers, biobanks, institutions, commercial organizations performing biomedical research, and regulatory authorities. This document is not applicable to metagenomic massive parallel sequencing (MPS), but it is applicable to multiplex molecular methods including 16S sequencing.
英文名称In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 3: Interpretation and reports