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Existing techniques, such as liquid chromatography\u2010mass spectrometry (LC\u2010MS) and capillary electrophoresis (CE), are resource\u2010intensive, requiring specialized equipment and expertise. To address this, a comprehensive lateral flow strip assay (LFSA) has been developed to evaluate key mRNA quality attributes\u20145' capping efficiency, integrity, and lipid nanoparticles (LNPs) encapsulation efficiency. Leveraging antibody\u2010labeled fluorescence nanoparticles and polydeoxythymidine oligonucleotide to simultaneously probe both 5' cap and poly(A) tail, the LFSA offers sequence\u2010independent, rapid (15\u00a0min), and sensitive mRNA analysis. Validation against standard methods demonstrates comparable accuracy while significantly reducing sample requirements and operational complexity. Moreover, the LFSA enables real\u2010time 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\u2010effective platform bridges critical gaps in mRNA QC, streamlines manufacturing workflows, and ensures mRNA therapeutic efficacy in diverse applications.<\/jats:p>","DOI":"10.1002\/advs.202502387","type":"journal-article","created":{"date-parts":[[2025,9,3]],"date-time":"2025-09-03T11:22:52Z","timestamp":1756898572000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["A Comprehensive Lateral Flow Strip Assay for On\u2010Site mRNA Vaccine Quality Control in Decentralized Manufacturing"],"prefix":"10.1002","volume":"12","author":[{"given":"Dengwang","family":"Luo","sequence":"first","affiliation":[{"name":"State Key Laboratory of Synthetic Biology Frontiers Science Center for Synthetic Biology (Ministry of Education) School of Synthetic Biology and Biomanufacturing Tianjin University  Tianjin 300072 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