Recently, the State Administration for Market Regulation, on April 19, the International Organization for Standardization (ISO) issued the "In Vitro Diagnostic Testing System-Requirements for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) by Nucleic Acid Amplification Method" and recommendations" (ISO/TS5798:2022) international standard
This is the first international standard issued by ISO specifically for the detection of the new coronavirus
On April 19, the International Organization for Standardization (ISO) issued the "In Vitro Diagnostic Testing System - Requirements and Recommendations for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) by Nucleic Acid Amplification" (ISO/TS5798:2022 ) international standards
The standard was proposed by the State Administration for Market Regulation (Standards Committee) organized by BGI, China National Institute of Standardization and other units and jointly developed with global experts.
It is the first international standard issued by ISO specifically for the detection of the new coronavirus
Combined with the characteristics and detection requirements of the new coronavirus, the standard puts forward technical requirements for the design, development, verification, confirmation and implementation of virus detection methods around the nucleic acid amplification method for virus diagnosis and screening
The standard stipulates the whole process steps of the virus detection analysis experiment, and defines the comprehensive evaluation indicators of virus detection such as accuracy, detection limit, inclusiveness, and specificity, and comprehensively builds a quality system for virus detection, which provides the quality control of virus detection.
The standard provides an important technical basis for global medical laboratories, in vitro diagnostic testing reagent developers and manufacturers and research institutions, and shares the advanced technological achievements and successful experience of nucleic acid testing with the world, in order to promote the safety and effectiveness of global epidemic prevention and control Sex played a positive role