Development and application progress of standards for antibody against SARS-CoV-2 / 中国生物制品学杂志

ABSTRACT

@#Coronavirus Disease 2019(COVID-19)caused by severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)seriously threatens human health and public health safety.Vaccination plays an important role in effectively controlling the epidemic situation.More than 150 SARS-CoV-2 vaccines have entered the clinical trial stage and 38 have been approved for emergency use or marketing.Neutralizing antibody level is the main index for evaluation of the immunogenicity of vaccines,but there has been no standardized detection method for SARS-CoV-2 neutralizing antibody till now,which makes it difficult to compare the neutralizing antibody levels among different laboratories and different products horizontally,and seriously restricts the development and evaluation of vaccines and antibody therapeutic drugs.With the rapid sale of the first generation of standards for SARS-CoV-2 antibody and the emergence of variants of concern(VOC)of SARS-CoV-2,WHO and China carried out the development of the second generation of standards simultaneously in 2022.This paper reviews the development and application progress of the standards for SARS-CoV-2 antibody in WHO and China.