Standard No.:	GB/Z 157-2026
English Name:	In vitro diagnostic test systems—Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods
Chinese Name:	体外诊断检验系统 核酸扩增法检测新型冠状病毒（SARS-CoV-2）的要求和建议
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	GB    National Standard
ICS Classification:	11.100.10 11.100.10    In vitro diagnostic test systems 11.100.10
Source Content Issued by:	SAMR;SAC
Issued on:	2026-1-28
Implemented on:	2026-1-28
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	20000 words
Translation Price(USD):	600.0
Delivery:	via email in 1~8 business day

本文件对核酸扩增检测SARS-CoV-2分析测试的设计、开发、验证、确认和实施提出要求和建议。本文件涉及人体标本的检验前、检验和检验后过程步骤。
本文件适用于医学实验室。本文件也供体外诊断开发人员、制造商以及支持SARS-CoV-2研究和诊断的机构和组织使用。
本文件不适用于环境样品。