26 April 2022 | News
The standard combines the characteristics and detection requirements of SARS-CoV-2
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According to the State Administration for Market Regulation in China, the International Organization for Standardization (ISO) has released the first international standard specifically for the detection of SARS-CoV-2, the virus that causes COVID-19.
ISO has issued "ISO/TS 5798:2022 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".
The standard was proposed by the Standardization Committee of the State Administration for Market Regulation that organized BGI, China National Institute of Standardization and other organizations and was jointly developed with global experts. It is the first international standard issued by ISO specifically for the detection of SARS-CoV-2.
The standard combines the characteristics and detection requirements of SARS-CoV-2, and puts forward technical requirements of the design, development, verification, confirmation and implementation of virus detection methods by nucleic acid amplification methods. The standard stipulates the whole process of the virus detection analysis experiment, and defines the comprehensive evaluation indicators of virus detection including accuracy, detection limit, inclusiveness, and specificity, and comprehensively builds a quality system for virus detection, which provides the quality control of virus detection with standards.