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