Establishment of the First National Standard for Neutralizing Antibodies against SARS-CoV-2 XBB Variants
Xuanxuan Zhang,
Lidong Guan,
Na Li,
Ying Wang,
Lu Li,
Mingchen Liu,
Qian He,
Jiansheng Lu,
Haiyuan Zeng,
Shan Yu,
Xinyi Guo,
Jiali Gong,
Jing Li,
Fan Gao,
Xing Wu,
Si Chen,
Qian Wang,
Zhongfang Wang,
Weijin Huang,
Qunying Mao,
Zhenglun Liang,
Miao Xu
Affiliations
Xuanxuan Zhang
Institute of Biological Products, National Institutes for Food and Drug Control, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, State Key Laboratory of Drug Regulatory Science, Beijing 102629, China
Lidong Guan
Institute of Biological Products, National Institutes for Food and Drug Control, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, State Key Laboratory of Drug Regulatory Science, Beijing 102629, China
Na Li
Beijing Minhai Biotechnology Co., Ltd., Beijing 102600, China
Ying Wang
Institute of Biological Products, National Institutes for Food and Drug Control, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, State Key Laboratory of Drug Regulatory Science, Beijing 102629, China
Lu Li
Institute of Biological Products, National Institutes for Food and Drug Control, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, State Key Laboratory of Drug Regulatory Science, Beijing 102629, China
Mingchen Liu
Institute of Biological Products, National Institutes for Food and Drug Control, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, State Key Laboratory of Drug Regulatory Science, Beijing 102629, China
Qian He
Institute of Biological Products, National Institutes for Food and Drug Control, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, State Key Laboratory of Drug Regulatory Science, Beijing 102629, China
Jiansheng Lu
Yunnan Institute for Food and Drug Control, Kunming 650106, China
Haiyuan Zeng
Yunnan Institute for Food and Drug Control, Kunming 650106, China
Shan Yu
Jiangsu Institute for Food and Drug Control, Nanjing 210019, China
Xinyi Guo
Hualan Biological Engineering Chongqing Co., Ltd., Chongqing 408107, China
Jiali Gong
China Resources Boya Bio-Pharmaceutical Group Co., Ltd., Fuzhou 344000, China
Jing Li
Beijing Kexing Zhongwei Biotechnology Co., Ltd., Beijing 102600, China
Fan Gao
Institute of Biological Products, National Institutes for Food and Drug Control, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, State Key Laboratory of Drug Regulatory Science, Beijing 102629, China
Xing Wu
Institute of Biological Products, National Institutes for Food and Drug Control, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, State Key Laboratory of Drug Regulatory Science, Beijing 102629, China
Si Chen
Drug and Vaccine Research Center, Guangzhou National Laboratory, Guangzhou 510535, China
Qian Wang
Drug and Vaccine Research Center, Guangzhou National Laboratory, Guangzhou 510535, China
Zhongfang Wang
Drug and Vaccine Research Center, Guangzhou National Laboratory, Guangzhou 510535, China
Weijin Huang
Institute of Biological Products, National Institutes for Food and Drug Control, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, State Key Laboratory of Drug Regulatory Science, Beijing 102629, China
Qunying Mao
Institute of Biological Products, National Institutes for Food and Drug Control, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, State Key Laboratory of Drug Regulatory Science, Beijing 102629, China
Zhenglun Liang
Institute of Biological Products, National Institutes for Food and Drug Control, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, State Key Laboratory of Drug Regulatory Science, Beijing 102629, China
Miao Xu
Institute of Biological Products, National Institutes for Food and Drug Control, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, State Key Laboratory of Drug Regulatory Science, Beijing 102629, China
Neutralizing antibodies (NtAbs) against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) are indicators of vaccine efficacy that enable immunity surveillance. However, the rapid mutation of SARS-CoV-2 variants prevents the timely establishment of standards required for effective XBB vaccine evaluation. Therefore, we prepared four candidate standards (No. 11, No. 44, No. 22, and No. 33) using plasma, purified immunoglobulin, and a broad-spectrum neutralizing monoclonal antibody. Collaborative calibration was conducted across nine Chinese laboratories using neutralization methods against 11 strains containing the XBB and BA.2.86 sublineages. This study demonstrated the reduced neutralization potency of the first International Standard antibodies to SARS-CoV-2 variants of concern against XBB variants. No. 44 displayed broad-spectrum neutralizing activity against XBB sublineages, effectively reduced interlaboratory variability for nearly all XBB variants, and effectively minimized the geometric mean titer (GMT) difference between the live and pseudotyped virus. No. 22 showed a broader spectrum and higher neutralizing activity against all strains but failed to reduce interlaboratory variability. Thus, No. 44 was approved as a National Standard for NtAbs against XBB variants, providing a unified NtAb measurement standard for XBB variants for the first time. Moreover, No. 22 was approved as a national reference reagent for NtAbs against SARS-CoV-2, offering a broad-spectrum activity reference for current and potentially emerging variants.
