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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...
Autores principales: | , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2023
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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. |
format | Online Article Text |
id | pubmed-9971588 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
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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