According to the State Administration for Market Regulation, the International Organization for Standardization (ISO) released the first international standard specifically for the detection of SARS-CoV-2, the virus that causes COVID-19.
On April 19, ISO 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.
The standard provides an important technical reference for global medical laboratories, vitro diagnostic developers and manufacturers and research institutions, sharing the technological achievements and successful experience of nucleic acid testing with the world.
Source: The Standardization Committee of the State Administration for Market Regulation