A chemiluminescence immunoassay for precise automatic quality control of glycoprotein in human rabies vaccine
A chemiluminescence immunoassay for precise automatic quality control of glycoprotein in human rabies vaccine
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DOI：
10.1016/j.vaccine.2021.10.060
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发表时间：
2021-12-09
期刊：
影响因子：
5.5
通讯作者：
Lin, Guanfeng
中科院分区：
文献类型：
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作者：
Ye, Ke;Shi, Dawei;Lin, Guanfeng
目前，人狂犬病疫苗中糖蛋白的质量控制主要基于酶联免疫吸附试验（ELISA）。然而，ELISA并不符合现代化质量控制系统的需要。长期以来，人狂犬病毒疫苗生产企业一直致力于寻求一种灵敏、准确、自动化、实际应用可行的检测平台。因此，我们的团队投入了大量的精力来建立一个全自动的基于微磁颗粒（MMP）的化学发光免疫测定（CLIA）平台。采用mmp偶联狂犬病病毒糖蛋白单克隆抗体（S037）捕获狂犬病毒，进行疫苗质量控制。加入另一种以吖啶酸酯标记的狂犬病毒糖蛋白抗体（S053）作为信号示踪剂。在对疫苗样品进行预处理后，使用全自动机器进行整个分析，该机器具有有限的检测时间（仅30分钟）并消除了人工错误。多次实验已经确定了有效和可靠地评估疫苗效力的最佳条件。CLIA平台具有速度快、鲁棒性好、灵敏度高（最小检出值为0.45 mIU/mL）、准确度高、线性范围宽（9.4-1200 mIU/mL）等优点。此外，结果表明，CLIA平台在定量分析上与美国国立卫生研究院测试和时间分辨荧光免疫测定（TRFIA）一致，且分析性能优于TRFIA。因此，本文提出的CLIA平台在现代疫苗质量控制中可能具有重要的应用价值。(c) 2021 Elsevier Ltd.版权所有。
Currently, quality control of glycoprotein in the human rabies vaccine is based on enzyme-linked immunosorbent assay (ELISA). However, ELISA does not match the needs of a modernised quality control system. For a long time, human rabies virus vaccine manufacturers have been devoted to seeking a detection platform that is sensitive, accurate, automatic, and feasible for practical applications. Therefore, our team invested major efforts into establishing a fully automated micromagnetic particle (MMP)-based chemiluminescence immunoassay (CLIA) platform. For vaccine quality control, MMP-coupled rabies virus glycoprotein monoclonal antibodies (S037) were used to capture the rabies virus. Another rabies virus glycoprotein antibody (S053) labelled with acridinium ester was added as a signal tracer. After pretreating the vaccine sample, the entire analysis was performed using a fully automated machine, which had a limited detection time (only 30 min) and eliminated manual error. Multiple experiments have identified the optimal conditions allowing valid and reliable assessment of vaccine potency. The CLIA platform has exhibited merits in terms of speed, robustness, high sensitivity (with a minimum detection value of 0.45 mIU/mL), considerable accuracy, and a wide linear range of detection (9.4-1200 mIU/mL). Furthermore, the results showed that the CLIA platform is consistent with the National Institutes of Health test and time-resolved fluorescent immunoassay (TRFIA) in quantitative analysis, and had a better analytic performance than TRFIA. Therefore, the CLIA platform presented here may be important for application in modern vaccine quality control. (c) 2021 Elsevier Ltd. All rights reserved.