On April 20, it was learned from the official website of the State Administration for Market Regulation that on April 19, the International Organization for Standardization (ISO) released the “In Vitro Diagnostic Testing System – Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV) by Nucleic Acid Amplification. CoV-2) requirements and recommendations” (ISO/TS 5798:2022) international standard. It is understood that the standard was proposed by the State Administration for Market Regulation (Standard 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 new coronaviruses. 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. standardized means. Standards provide important .
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