本文件提供了使用核酸扩增检测严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的分析测试的设计、开发、验证、验证和实施的要求和建议。它涉及人体标本的检查前、检查和检查后过程步骤。 本文件适用于医学实验室。它也被用于体外诊断开发者和制造商，以及支持SARS-CoV-2研究和诊断的机构和组织。 本文件不适用于环境样品。

This document provides requirements and recommendations for the design, development, verification, validation and implementation of analytical tests for detecting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using nucleic acid amplification. It addresses pre-examination, examination and post-examination process steps for human specimens. This document is applicable to medical laboratories. It is also intended to be used by in vitro diagnostic developers and manufacturers, as well as by institutions and organizations supporting SARS-CoV-2 research and diagnostics. This document does not apply to environmental samples.