Simultaneous quantification of spike and nucleocapsid protein in inactivated COVID-19 vaccine bulk by liquid chromatography-tandem mass spectrometry.
Simultaneous quantification of spike and nucleocapsid protein in inactivated COVID-19 vaccine bulk by liquid chromatography-tandem mass spectrometry.
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通过液相色谱-串联质谱同时定量灭活 COVID-19 疫苗中的刺突蛋白和核衣壳蛋白。
DOI：
10.1016/j.jchromb.2021.122884
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发表时间：
2021-09-01
期刊：
影响因子：
--
通讯作者：
Bo T
中科院分区：
文献类型：
--
作者：
Long Z;Wei C;Dong X;Li X;Yang H;Deng H;Ma X;Yin S;Qi Y;Bo T
严重急性呼吸道综合征冠状病毒2型（SARS-CoV-2）疫苗是控制COVID-19大流行最有希望的方法。迫切需要开发可靠的分析方法，以确保质量控制，并评估疫苗的长期有效性和安全性。尽管体内动物试验，如基于血清的ELISA，通常用于疫苗的质量控制，但这些方法精度差，劳动强度大，并且需要昂贵的特异性抗体。因此，人们对开发稳健的生物分析测定法作为复杂疫苗抗原的定性和定量评价的替代方法越来越感兴趣。本研究利用优化的独特肽段建立了一种液相色谱串联质谱法，用于同时测定刺突蛋白（S）和核衣壳蛋白（N）。方法灵敏度，线性，重复性，选择性和回收率进行了评价。对9批COVID-19灭活疫苗中S和N蛋白的量进行了定量，其相对于总蛋白含量的组成一致。我们相信这种方法可以应用于其他基于S和/或N蛋白的COVID-19疫苗的质量评价，并可以扩展到其他病毒载体和基于蛋白亚基的疫苗。
Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccines are the most promising approach to control the COVID-19 pandemic. There are eminent needs to develop robust analytical methods to ensure quality control, as well as to evaluate the long-term efficacy and safety of vaccine. Although in vivo animal tests, such as serum-based ELISA, have been commonly used for quality control of vaccines, these methods have poor precision, are labor intensive, and require the availability of expensive, specific antibodies. Thus, there is growing interest to develop robust bioanalytical assays as alternatives for qualitative and quantitative evaluation of complex vaccine antigens. In this study, a liquid chromatography tandem mass spectrometry method was developed using optimized unique peptides for simultaneous determination of spike (S) and nucleocapsid (N) protein. Method sensitivity, linearity, repeatability, selectivity, and recovery were evaluated. The amount of S and N proteins in 9 batches of inactivated COVID-19 vaccines were quantified, and their compositions relative to total protein content were consistent. We believe this method can be applied for quality evaluation of other S and/or N protein based COVID-19 vaccine, and could be extended to other viral vector, and protein subunit-based vaccines.
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影响因子：
5.9
作者：
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通讯作者：
Renfrow, Matthew B.
影响因子：
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作者：
Garcia, Leidy Y.;Cerda, Arcadio A.
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Cerda, Arcadio A.
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DOI：
10.1016/j.bbrc.2014.07.090
发表时间：
2014-08-22
影响因子：
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