Evidence map›Paper›PMID 40899607›Full record

ArticleAdvanced science (Weinheim, Baden-Wurttemberg, Germany)2025

A Comprehensive Lateral Flow Strip Assay for On-Site mRNA Vaccine Quality Control in Decentralized Manufacturing.

Dengwang Luo, Ziwei Zhang, Jing Guo, Jieli Zhang, Arong Huang, Qinghao Cao, Jiangnan Zheng, Yingjin Yuan, Daming Wang, Yuhong Cao

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Advanced science (Weinheim, Baden-Wurttemberg, Germany), 2025. 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

10 authors.

Dengwang LuoState Key Laboratory of Synthetic Biology, Frontiers Science Center for Synthetic Biology (Ministry of Education), School of Synthetic Biology and Biomanufacturing, Tianjin University, Tianjin, 300072, China.
Ziwei ZhangCAS Key Laboratory for Biological Effects of Nanomaterials and Nanosafety, National Center for Nanoscience and Technology, Chinese Academy of Sciences, Beijing, 100190, China.
Jing GuoCollege of Nanoscience and Technology, University of Chinese Academy of Sciences, Beijing, 100049, China.
Jieli ZhangAnbio Biotechnology Company, Xiamen, Fujian, 361026, China.
Arong HuangAnbio Biotechnology Company, Xiamen, Fujian, 361026, China.
Qinghao CaoCAS Key Laboratory of Molecular Recognition and Function, Chinese Academy of Sciences, Beijing, 100190, China.
Jiangnan ZhengCAS Key Laboratory for Biological Effects of Nanomaterials and Nanosafety, National Center for Nanoscience and Technology, Chinese Academy of Sciences, Beijing, 100190, China.
Yingjin YuanState Key Laboratory of Synthetic Biology, Frontiers Science Center for Synthetic Biology (Ministry of Education), School of Synthetic Biology and Biomanufacturing, Tianjin University, Tianjin, 300072, China.
Daming WangAnbio Biotechnology Company, Xiamen, Fujian, 361026, China.
Yuhong CaoCAS Key Laboratory for Biological Effects of Nanomaterials and Nanosafety, National Center for Nanoscience and Technology, Chinese Academy of Sciences, Beijing, 100190, China.ORCID https://orcid.org/0000-0001-8065-4634

Funding

CAS Project for Young Scientists in Basic Research YSBR-010Chinese Academy of Science YSBR-010National Key Research and Development Program of China 2021YFA1201100National Key Research and Development Program of China Nos.2021YFC2302400National Natural Science Foundation of China No.32271516
6 · The paper itself

Abstract

The rapid adoption of mRNA-based vaccines highlights the critical need for on-site quality control (QC) methods, particularly in low-income countries with decentralized manufacturing. Existing techniques, such as liquid chromatography-mass spectrometry (LC-MS) and capillary electrophoresis (CE), are resource-intensive, requiring specialized equipment and expertise. To address this, a comprehensive lateral flow strip assay (LFSA) has been developed to evaluate key mRNA quality attributes-5' capping efficiency, integrity, and lipid nanoparticles (LNPs) encapsulation efficiency. Leveraging antibody-labeled fluorescence nanoparticles and polydeoxythymidine oligonucleotide to simultaneously probe both 5' cap and poly(A) tail, the LFSA offers sequence-independent, rapid (15 min), and sensitive mRNA analysis. Validation against standard methods demonstrates comparable accuracy while significantly reducing sample requirements and operational complexity. Moreover, the LFSA enables real-time monitoring of mRNA stability under varying storage conditions and provides precise encapsulation assessments, distinguishing between intact and degraded mRNA in LNPs. This portable and cost-effective platform bridges critical gaps in mRNA QC, streamlines manufacturing workflows, and ensures mRNA therapeutic efficacy in diverse applications.

Indexed as

mRNA VaccinesRNA, MessengerVaccines, SyntheticHumansNanoparticlesQuality ControlmRNA VaccinesRNA, MessengerVaccines, Synthetic5' capping efficiencyencapsulation efficiencyintegritylateral flow strip assaymRNA vaccine

Identifiers

PMID40899607
PMCPMC12631917

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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.