Evidence map›Paper›PMID 39459848›Full record

ArticleViruses2024

Methodological Validation and Inter-Laboratory Comparison of Microneutralization Assay for Detecting Anti-AAV9 Neutralizing Antibody in Human.

Shuangqing Yu, Qian Zhao, Cengceng Zhang, Diyi Fu, Xueyang Zhu, Jianfang Zhou, Wenhao Ma, Zheyue Dong, Xiaoliang Zhai, Lijie Jiang and 4 more

Abstract readComparative StudyValidation Study
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. Review
  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

14 authors.

Shuangqing YuGenecradle Therapeutics Inc., Beijing 100176, China.
Qian ZhaoClinical Pharmacology Research Center, State Key Laboratory of Complex Severe and Rare Diseases, NMPA Key Laboratory for Clinical Research and Evaluation of Drug, Beijing Key Laboratory of Clinical PK and PD Investigation for Innovative Drugs, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China.
Cengceng ZhangGenecradle Therapeutics Inc., Beijing 100176, China.
Diyi FuClinical Pharmacology Research Center, State Key Laboratory of Complex Severe and Rare Diseases, NMPA Key Laboratory for Clinical Research and Evaluation of Drug, Beijing Key Laboratory of Clinical PK and PD Investigation for Innovative Drugs, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China.
Xueyang ZhuGenecradle Therapeutics Inc., Beijing 100176, China.
Jianfang ZhouGenecradle Therapeutics Inc., Beijing 100176, China.
Wenhao MaGenecradle Therapeutics Inc., Beijing 100176, China.ORCID 0000-0003-3441-4976
Zheyue DongBeijing FivePlus Gene Technology Co., Ltd., Beijing 102629, China.
Xiaoliang ZhaiBeijing Joinn Laboratory Co., Ltd., Beijing 100176, China.
Lijie JiangBeijing Joinn Laboratory Co., Ltd., Beijing 100176, China.
Xiaohong HanClinical Pharmacology Research Center, State Key Laboratory of Complex Severe and Rare Diseases, NMPA Key Laboratory for Clinical Research and Evaluation of Drug, Beijing Key Laboratory of Clinical PK and PD Investigation for Innovative Drugs, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China.ORCID 0000-0001-9190-0167
Shuyang ZhangClinical Pharmacology Research Center, State Key Laboratory of Complex Severe and Rare Diseases, NMPA Key Laboratory for Clinical Research and Evaluation of Drug, Beijing Key Laboratory of Clinical PK and PD Investigation for Innovative Drugs, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China.
Xiaobing WuGenecradle Therapeutics Inc., Beijing 100176, China.
Xiaoyan DongGenecradle Therapeutics Inc., Beijing 100176, China.

Funding

Beijing E-town Cooperation & Development Foundation YCXJ-JZ-2022-007(28)CAMS Innovation Fund for Medical Sciences CIFMS2021-I2M-1-003National High-Level Hospital Clinical Research Funding 2022-PUMCH-A-144
6 · The paper itself

Abstract

Anti-AAV neutralizing Abs (NAbs) titer is usually measured by cell-based microneutralization (MN) assay and is crucial for patient screening in AAV-based gene therapy clinical trials. However, achieving uniform operation and comparable results among different laboratories remains challenging. Here, we established a standardized MN assay for anti-AAV9 NAbs in human sera or plasma and transferred the method to the other two research teams. Then, we validated its parameters and tested a set of eight human samples in blind across all laboratories. The end-point titer, defined by a transduction inhibition of 50% (IC

Indexed as

Antibodies, NeutralizingAntibodies, ViralDependovirusNeutralization TestsAnimalsHumansMiceReproducibility of ResultsSensitivity and SpecificityAntibodies, NeutralizingAntibodies, Viraladeno-associated virusmicroneutralization assayneutralizing antibodyprecisionreproducibilitysensitivityspecificitysystem suitability

Identifiers

PMID39459848
PMCPMC11512302

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.