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开发一种化学发光酶免疫试验 (CLEIA) 用于在HPV疫苗中定量L1蛋白

ChengRui Fei¹, Huan Yang¹, SiJie Wang¹

¹Yunnan Institute for Food and Drug Control, Kunming, Yunnan, 650500, PR China; Public Service Platform for Industrial Technology Foundation of the Ministry of Industry and Information Technology, Kunming, Yunnan, 650500, PR China.

Analytical biochemistry

|May 4, 2025

概括

一种新的化学发光免疫测试精确量化了疫苗中的人类乳头瘤病毒 (HPV) L1蛋白. 这种方法确保了双价HPV疫苗的疫苗质量和抗原活性.

科学领域:

生物化学生物化学
免疫学免疫学免疫学
疫苗开发疫苗开发

背景情况:

L1蛋白是人类乳头瘤病毒 (HPV) 的主要组成部分.
商业HPV疫苗使用L1蛋白自组装成类似病毒的颗粒 (VLP).
准确的L1蛋白质定量对于评估HPV疫苗抗原性功效至关重要.

研究的目的:

开发和验证化学发光酶免疫测试 (CLEIA) 以精确量化双价HPV疫苗中的L1蛋白质.

主要方法:

在96孔微板上使用了三明治免疫测试格式.
捕获抗体固定了抗原-抗体复合体.
与HRP结合的二次抗体检测到复合体,通过醇/过氧化催化剂信号放大.

主要成果:

优化的CLEIA显示出出色的可重现性 (试验间CV<4%) 和准确性 (100.5±2.8%对于16L1,95.5±6.4%对于18L1).
高精度 (试验间CV<7%) 和灵敏度 (LOQ:0.0996微克/毫升对于HPV16L1,0.1459微克/毫升对于HPV18L1) 得到了实现.
该试验为双价HPV疫苗中L1蛋白质定量提供了可靠的平台.

结论:

一种经过验证的CLEIA方法可以在双价HPV疫苗中精确,准确和敏感地定量L1蛋白.
这种测试支持HPV疫苗的强有力的质量控制和功效评估.

关键词:

化学发光酶免疫检测化学发光酶免疫检测内容检测内容检测这是一个HPVHPVHPV.这是一种L1蛋白质.

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Enzyme-Linked Immunosorbent Assay

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