本文件规定了用于微生物组DNA检查的人类标本（如粪便、唾液、皮肤和泌尿生殖道标本）的检查前阶段的要求和建议。预检查阶段包括但不限于样本收集、处理、运输、储存、处理、DNA分离和文件记录。 本文件适用于医学实验室进行的分子体外诊断检查。它也适用于实验室客户、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。 对于传染病检查（如靶向病原体鉴定）和组织中微生物组DNA检查（如。 g。活组织检查）。这些超出了本文件的范围。 对人类基因组DNA检测唾液的预检测过程采取了不同的专用措施。这些未在本文件中描述，但包含在CEN/TS 17305《分子体外诊断检查-唾液分离DNA预检查过程规范》中。 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 gives recommendations for the pre-examination phase of human specimens, such as stool, saliva, skin and urogenital specimens, intended for microbiome DNA examination. The pre-examination phase includes but is not limited to specimen collection, handling, transport, storage, processing, isolation of DNA, and documentation. This document is applicable to molecular in vitro diagnostic examinations 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. Different dedicated measures are taken for pre-examination processes for infectious disease examination (e.g. targeted pathogen identification) and for microbiome DNA examination from tissue (e.g. biopsies). These are outside of the scope of this document. Different dedicated measures are taken for pre-examination processes for saliva for human genomic DNA examination. These are not described in this document but are covered in CEN/TS 17305, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated DNA. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.