BEIJING, April 26, 2022 /PRNewswire/ — According to the State Administration for Industry Regulation, the International Organization for Standardization (ISO) introduced the very first intercontinental normal particularly for the detection of SARS-CoV-2, the virus that triggers COVID-19.
On April 19, ISO issued “ISO/TS 5798:2022 In vitro diagnostic check devices — Needs and recommendations for detection of extreme acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification techniques”. The typical was proposed by the Standardization Committee of the State Administration for Market place Regulation that structured BGI, China Countrywide Institute of Standardization and other companies and was jointly formulated with worldwide industry experts. It is the initially intercontinental standard issued by ISO precisely for the detection of SARS-CoV-2.
The regular combines the qualities and detection demands of SARS-CoV-2, and places ahead complex prerequisites of the style and design, advancement, verification, confirmation and implementation of virus detection techniques by nucleic acid amplification approaches. The conventional stipulates the complete course of action of the virus detection examination experiment, and defines the in depth evaluation indicators of virus detection such as accuracy, detection restrict, inclusiveness, and specificity, and comprehensively builds a high-quality method for virus detection, which provides the high-quality command of virus detection with standards.
The regular presents an essential technical reference for world medical laboratories, vitro diagnostic builders and makers and research institutions, sharing the technological achievements and prosperous working experience of nucleic acid tests with the entire world.