标准编号：ISO 21474-1:2020
中文名称：体外诊断医疗器械 核酸的多元分子试验 第1部分：核酸质量评价的术语和一般要求
英文名称：In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation
发布日期：2020-08
标准范围
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”.
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