GB/Z 157-2026
ActiveIn vitro diagnostic test systems—Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods
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
Application Summary AI generated
This standard provides technical requirements and recommendations for in vitro diagnostic test systems that use nucleic acid amplification methods to detect SARS-CoV-2. It is applied by manufacturers, laboratories, and regulatory bodies in the healthcare and medical device sectors to ensure the quality, reliability, and performance of COVID-19 molecular diagnostic tests. The standard covers aspects such as sample handling, assay design, validation, and result interpretation for clinical testing and public health surveillance.
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Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.