ISO 4307:2021 分子体外诊断检验 唾液分离的人类DNA的预检验过程规范

标准编号：ISO 4307:2021

中文名称：分子体外诊断检验 唾液分离的人类DNA的预检验过程规范

英文名称：Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated human DNA

发布日期：2021-10

标准范围

本文件规定了在进行分子检测前的检测前阶段，用于人类DNA检测的唾液样本的处理、储存、处理和记录的要求和建议。本文件适用于分子体外诊断检查，包括由医学实验室进行的实验室开发测试。它还可用于实验室客户、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。本文件中未说明吸收材料或漱口液收集的唾液需要采取的专门措施。也没有描述保存和处理唾液中天然无细胞DNA、病原体和其他细菌或整个微生物DNA的措施。注:国际、国家或地区法规或要求也可适用于本文件所涵盖的特定主题。

This document specifies requirements and recommendations on the handling, storage, processing and documentation of saliva specimens intended for human DNA examination during the pre-examination phase before a molecular examination is performed.This document is applicable to molecular in vitro diagnostic examination including laboratory developed tests performed by medical laboratories. It can also be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.Dedicated measures that need to be taken for saliva collected on absorbing material or by mouth washes are not described in this document. Neither are measures for preserving and handling of native saliva cell-free DNA, pathogens, and other bacterial or whole microbiome DNA in saliva described.NOTE       International, national or regional regulations or requirements can also apply to specific topics covered in this document.

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