本文件规定了在进行分子检测之前的检测前阶段，用于人类DNA检测的唾液样本的处理、储存、处理和记录要求。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。它还打算用于实验室客户、体外诊断开发人员和制造商、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。本技术规范中未说明吸收材料或漱口液收集唾液需要采取的专门措施。也没有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 gives requirements 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 is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations 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 technical specification. 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.