Reprint |Two national standards of "Quality Evaluation Requirements for COVID-19 Antibody Test Kits" were officially released

Jan 04, 2022

Recently, the National Standards Information Service Platform has released a list of 2019 standards issued by the China Institute for Food and Drug Control, the General Hospital of the Chinese People's Liberation Army, the Medical Device Technology Review Center of the State Drug Administration, the Beijing Institute of Medical Device Testing, and the Institute of Pathogen Biology, Chinese Academy of Medical Sciences. , "Quality Evaluation Requirements for Novel Coronavirus IgG Antibody Detection Kits" jointly drafted by 8 units of Zhuhai Livzon Reagent Co., Ltd., Boosaics (Chongqing) Biotechnology Co., Ltd., and Dana (Tianjin) Biotechnology Co., Ltd., Two national standards for "Quality Evaluation Requirements for Novel Coronavirus IgM Antibody Detection Kits".

Standard task source

The standard task comes from the National Standards Management Committee's "Notice on the issuance of 8 recommended national standards including "Quality Evaluation Requirements for Novel Coronavirus Nucleic Acid Detection Kits" (task number: 202001827-T-464); A large number of investigations were conducted to form a draft, and the Secretariat of the National Standardization Technical Committee for Medical Clinical Testing Laboratories and In Vitro Diagnostic Systems (SAC/TC136) and the Device Evaluation Center of the State Drug Administration were invited to clarify the relevant content.

The significance of standard setting

Up to now, more than 10 new coronavirus antibody IgM/IgG antibody detection kit products have been approved by my country's drug administration for the detection of antibodies in patients in the new coronavirus pneumonia epidemic. According to incomplete statistics, there are more than 30 A company has issued an EU CE self-conformity declaration. Therefore, related products are not only needed for the prevention and control of the new crown pneumonia epidemic at home and abroad, but also involve greater foreign economic and trade and the country's international responsibilities. Up to now, there is no standard for new coronavirus antibody detection products at home and abroad. The two national standards released this time are applicable to the production and quality evaluation of detection kits for the detection of 2019-nCoV antibodies in serum, plasma and whole blood samples. The evaluation requirements, test methods, packaging and transportation are specified in detail. By implementing the above two standards, the existing domestic new coronavirus detection products can be fully regulated, which will help to comprehensively evaluate the quality of the new coronavirus detection products to better meet the needs of clinical diagnosis. The standard will be officially implemented on March 1, 2022.

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