本文件规定了在进行分子检测前的预检测阶段，用于DNA检测的冷冻组织样本的处理、储存、处理和记录的要求，并给出了建议。 本文件适用于分子体外诊断检查，包括由医学实验室和分子病理学实验室进行的实验室开发测试，用于评估从冷冻组织中分离的DNA。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。 本文件不包括冷冻前经过化学稳定预处理的组织。 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 handling, storage, processing, and documentation of frozen tissue specimens intended for DNA examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that evaluate DNA isolated from frozen tissue. 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. Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document. NOTE？International, national, or regional regulations or requirements can also apply to specific topics covered in this document.