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Establishment of national standard for anti-SARS-Cov-2 neutralizing antibody in China: The first National Standard calibration traceability to the WHO International Standard

Neutralizing antibody (NtAb) levels are key indicators in the development and evaluation of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccines. Establishing a unified and reliable WHO International Standard (IS) for NtAb is crucial for the calibration and harmonization of NtAb det...

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Autores principales: Guan, Lidong, Mao, Qunying, Tan, Dejiang, Liu, Jianyang, Zhang, Xuanxuan, Li, Lu, Liu, Mingchen, Wang, Zhongfang, Cheng, Feiran, Cui, Bopei, He, Qian, Wang, Qingzhou, Gao, Fan, Wang, Yiping, Bian, Lianlian, Wu, Xing, Hou, Jifeng, Liang, Zhenglun, Xu, Miao
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9971588/
https://www.ncbi.nlm.nih.gov/pubmed/36865542
http://dx.doi.org/10.3389/fimmu.2023.1107639
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author Guan, Lidong
Mao, Qunying
Tan, Dejiang
Liu, Jianyang
Zhang, Xuanxuan
Li, Lu
Liu, Mingchen
Wang, Zhongfang
Cheng, Feiran
Cui, Bopei
He, Qian
Wang, Qingzhou
Gao, Fan
Wang, Yiping
Bian, Lianlian
Wu, Xing
Hou, Jifeng
Liang, Zhenglun
Xu, Miao
author_facet Guan, Lidong
Mao, Qunying
Tan, Dejiang
Liu, Jianyang
Zhang, Xuanxuan
Li, Lu
Liu, Mingchen
Wang, Zhongfang
Cheng, Feiran
Cui, Bopei
He, Qian
Wang, Qingzhou
Gao, Fan
Wang, Yiping
Bian, Lianlian
Wu, Xing
Hou, Jifeng
Liang, Zhenglun
Xu, Miao
author_sort Guan, Lidong
collection PubMed
description Neutralizing antibody (NtAb) levels are key indicators in the development and evaluation of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccines. Establishing a unified and reliable WHO International Standard (IS) for NtAb is crucial for the calibration and harmonization of NtAb detection assays. National and other WHO secondary standards are key links in the transfer of IS to working standards but are often overlooked. The Chinese National Standard (NS) and WHO IS were developed by China and WHO in September and December 2020, respectively, the application of which prompted and coordinated sero-detection of vaccine and therapy globally. Currently, a second-generation Chinese NS is urgently required owing to the depletion of stocks and need for calibration to the WHO IS. The Chinese National Institutes for Food and Drug Control (NIFDC) developed two candidate NSs (samples 33 and 66–99) traced to the IS according to the WHO manual for the establishment of national secondary standards through a collaborative study of nine experienced labs. Either NS candidate can reduce the systematic error among different laboratories and the difference between the live virus neutralization (Neut) and pseudovirus neutralization (PsN) methods, ensuring the accuracy and comparability of NtAb test results among multiple labs and methods, especially for samples 66–99. At present, samples 66–99 have been approved as the second-generation NS, which is the first NS calibrated tracing to the IS with 580 (460–740) International Units (IU)/mL and 580 (520–640) IU/mL by Neut and PsN, respectively. The use of standards improves the reliability and comparability of NtAb detection, ensuring the continuity of the use of the IS unitage, which effectively promotes the development and application of SARS-CoV-2 vaccines in China.
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spelling pubmed-99715882023-03-01 Establishment of national standard for anti-SARS-Cov-2 neutralizing antibody in China: The first National Standard calibration traceability to the WHO International Standard Guan, Lidong Mao, Qunying Tan, Dejiang Liu, Jianyang Zhang, Xuanxuan Li, Lu Liu, Mingchen Wang, Zhongfang Cheng, Feiran Cui, Bopei He, Qian Wang, Qingzhou Gao, Fan Wang, Yiping Bian, Lianlian Wu, Xing Hou, Jifeng Liang, Zhenglun Xu, Miao Front Immunol Immunology Neutralizing antibody (NtAb) levels are key indicators in the development and evaluation of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccines. Establishing a unified and reliable WHO International Standard (IS) for NtAb is crucial for the calibration and harmonization of NtAb detection assays. National and other WHO secondary standards are key links in the transfer of IS to working standards but are often overlooked. The Chinese National Standard (NS) and WHO IS were developed by China and WHO in September and December 2020, respectively, the application of which prompted and coordinated sero-detection of vaccine and therapy globally. Currently, a second-generation Chinese NS is urgently required owing to the depletion of stocks and need for calibration to the WHO IS. The Chinese National Institutes for Food and Drug Control (NIFDC) developed two candidate NSs (samples 33 and 66–99) traced to the IS according to the WHO manual for the establishment of national secondary standards through a collaborative study of nine experienced labs. Either NS candidate can reduce the systematic error among different laboratories and the difference between the live virus neutralization (Neut) and pseudovirus neutralization (PsN) methods, ensuring the accuracy and comparability of NtAb test results among multiple labs and methods, especially for samples 66–99. At present, samples 66–99 have been approved as the second-generation NS, which is the first NS calibrated tracing to the IS with 580 (460–740) International Units (IU)/mL and 580 (520–640) IU/mL by Neut and PsN, respectively. The use of standards improves the reliability and comparability of NtAb detection, ensuring the continuity of the use of the IS unitage, which effectively promotes the development and application of SARS-CoV-2 vaccines in China. Frontiers Media S.A. 2023-02-14 /pmc/articles/PMC9971588/ /pubmed/36865542 http://dx.doi.org/10.3389/fimmu.2023.1107639 Text en Copyright © 2023 Guan, Mao, Tan, Liu, Zhang, Li, Liu, Wang, Cheng, Cui, He, Wang, Gao, Wang, Bian, Wu, Hou, Liang and Xu https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Immunology
Guan, Lidong
Mao, Qunying
Tan, Dejiang
Liu, Jianyang
Zhang, Xuanxuan
Li, Lu
Liu, Mingchen
Wang, Zhongfang
Cheng, Feiran
Cui, Bopei
He, Qian
Wang, Qingzhou
Gao, Fan
Wang, Yiping
Bian, Lianlian
Wu, Xing
Hou, Jifeng
Liang, Zhenglun
Xu, Miao
Establishment of national standard for anti-SARS-Cov-2 neutralizing antibody in China: The first National Standard calibration traceability to the WHO International Standard
title Establishment of national standard for anti-SARS-Cov-2 neutralizing antibody in China: The first National Standard calibration traceability to the WHO International Standard
title_full Establishment of national standard for anti-SARS-Cov-2 neutralizing antibody in China: The first National Standard calibration traceability to the WHO International Standard
title_fullStr Establishment of national standard for anti-SARS-Cov-2 neutralizing antibody in China: The first National Standard calibration traceability to the WHO International Standard
title_full_unstemmed Establishment of national standard for anti-SARS-Cov-2 neutralizing antibody in China: The first National Standard calibration traceability to the WHO International Standard
title_short Establishment of national standard for anti-SARS-Cov-2 neutralizing antibody in China: The first National Standard calibration traceability to the WHO International Standard
title_sort establishment of national standard for anti-sars-cov-2 neutralizing antibody in china: the first national standard calibration traceability to the who international standard
topic Immunology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9971588/
https://www.ncbi.nlm.nih.gov/pubmed/36865542
http://dx.doi.org/10.3389/fimmu.2023.1107639
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