分子体外诊断检查.唾液预检查过程规范.分离的人类DNA

[中文适用范围]： 本文件规定了在进行分子检查之前的预检查阶段用于人类 DNA 检查的唾液样本的处理、储存、加工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的测试。 它还可供实验室客户、体外诊断开发商和制造商、生物银行、进行生物医学研究的机构和商业组织以及监管机构使用。 本文件没有描述需要对吸收材料或漱口水收集的唾液采取的专门措施。 也没有描述保存和处理唾液中天然唾液无细胞 DNA、病原体和其他细菌或整个微生物组 DNA 的措施。 注：国际、国家或地区法规或要求也适用于本文件中涵盖的特定主题。 [外文原描述]： 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.