This document gives the general requirements for validation and verification 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 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 either 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 (IVD) examination performed by medical laboratories. It is also intended to be used by laboratory customers, IVD 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”.
ISO 21474-2:2022由国际标准化组织 IX-ISO 发布于 2022-05-13。
* 在 ISO 21474-2:2022 发布之后有更新,请注意新发布标准的变化。
为此,中国测试技术研究院联合相关单位,等同采用国际标准,牵头制定了GB/T 42076.1-2022《生物技术 细胞计数 第1部分:细胞计数方法通则》和GB/T 42077-2022《生物技术 核酸靶序列定量方法的性能评价要求 qPCR法和dPCR法》两项国家标准,已于近期获得发布实施,为我国细胞计数和核酸靶序列定量测定满足国际标准要求提供了标准依据,并为生命健康产业相关技术应用奠定了技术基础。...
methods》〔体外诊断检测系统-核酸扩增法检测新型冠状病毒(SARS-CoV-2)的要求及建议〕,获国际标准化组织(ISO)批准发布(ISO/TS 5798:2022)。...
在整个实验中,试验体外诊断试剂和对比方法均应处于有效的质量控制下,最大限度保证试验数据的准确性及可重复性。 2.临床试验设计 2.1 与对比方法/试剂的比较研究 2.1.1申请人可采用核酸序列测定方法作为参比方法,验证试验体外诊断试剂检测结果与核酸序列测定(测序)结果之间的一致性。...
2021.2月国务院令第739号《医疗器械监督管理条例》第53条:对国内尚无同品种产品上市的体外诊断试剂,符合条件的医疗机构根据本单位的临床需要,可以自行研制,在执业医师指导下在本单位内使用。具体管理办法由国务院药品监督管理部门会同国务院卫生主管部门制定。...
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