Evidence map›Paper›PMID 38675896›Full record

ArticleViruses2024

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 and 12 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Viruses, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Xuanxuan ZhangInstitute 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 GuanInstitute 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 LiBeijing Minhai Biotechnology Co., Ltd., Beijing 102600, China.
Ying WangInstitute 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 LiInstitute 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 LiuInstitute 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 HeInstitute 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 LuYunnan Institute for Food and Drug Control, Kunming 650106, China.
Haiyuan ZengYunnan Institute for Food and Drug Control, Kunming 650106, China.
Shan YuJiangsu Institute for Food and Drug Control, Nanjing 210019, China.
Xinyi GuoHualan Biological Engineering Chongqing Co., Ltd., Chongqing 408107, China.
Jiali GongChina Resources Boya Bio-Pharmaceutical Group Co., Ltd., Fuzhou 344000, China.
Jing LiBeijing Kexing Zhongwei Biotechnology Co., Ltd., Beijing 102600, China.
Fan GaoInstitute 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 WuInstitute 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 ChenDrug and Vaccine Research Center, Guangzhou National Laboratory, Guangzhou 510535, China.
Qian WangDrug and Vaccine Research Center, Guangzhou National Laboratory, Guangzhou 510535, China.
Zhongfang WangDrug and Vaccine Research Center, Guangzhou National Laboratory, Guangzhou 510535, China.
Weijin HuangInstitute 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.ORCID 0000-0002-4246-8889
Qunying MaoInstitute 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 LiangInstitute 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 XuInstitute 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.

Funding

R&D Program of Guangzhou National Laboratory SRPG23-005
6 · The paper itself

Abstract

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.

Indexed as

Antibodies, NeutralizingAntibodies, ViralCOVID-19Neutralization TestsSARS-CoV-2Antibodies, MonoclonalChinaCOVID-19 VaccinesHumansSpike Glycoprotein, CoronavirusAntibodies, MonoclonalAntibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesSpike Glycoprotein, Coronavirusneutralizing antibodyreference reagentSARS-CoV-2standardstandard materialXBB variants

Identifiers

PMID38675896
PMCPMC11053542

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.