Title Development and Evaluation of a Pseudovirus-Luciferase Assay for Rapid and Quantitative Detection of Neutralizing Antibodies against Enterovirus 71
Authors Wu, Xing
Mao, Qunying
Yao, Xin
Chen, Pan
Chen, Xiangmei
Shao, Jie
Gao, Fan
Yu, Xiang
Zhu, Fengcai
Li, Rongcheng
Li, Wenhui
Liang, Zhenglun
Wang, Junzhi
Lu, Fengmin
Affiliation Peking Univ, Hlth Sci Ctr, Dept Microbiol, Beijing 100871, Peoples R China.
Peking Univ, Hlth Sci Ctr, Ctr Infect Dis, Beijing 100871, Peoples R China.
Minist Hlth Res Qual & Standardizat Biotech Prod, Natl Inst Food & Drug Control, Dept Hepatitis Vaccine, Key Lab, Beijing, Peoples R China.
Natl Inst Biol Sci, Beijing, Peoples R China.
Hualan Biol Engn Inc, Xinxiang, Henan, Peoples R China.
Jiangsu Prov Ctr Dis Prevent & Control, Nanjing, Jiangsu, Peoples R China.
Guangxi Zhuang Automomous Reg, Ctr Dis Control & Prevent, Nanning, Peoples R China.
Keywords COXSACKIEVIRUS A16
INFECTION
VIRUS
TAIWAN
ANTIGENICITY
STRAINS
VACCINE
MICE
IMMUNIZATION
VALIDATION
Issue Date 2013
Publisher plos one
Citation PLOS ONE.2013,8,(6).
Abstract The level of neutralizing antibodies (NtAb) induced by vaccine inoculation is an important endpoint to evaluate the efficacy of EV71 vaccine. In order to evaluate the efficacy of EV71 vaccine, here, we reported the development of a novel pseudovirus system expression firefly luciferase (PVLA) for the quantitative measurement of NtAb. We first evaluated and validated the sensitivity and specificity of the PVLA method. A total of 326 serum samples from an epidemiological survey and 144 serum specimens from 3 clinical trials of EV71 vaccines were used, and the level of each specimen's neutralizing antibodies (NtAb) was measured in parallel using both the conventional CPE-based and PVLA-based assay. Against the standard neutralization assay based on the inhibition of the cytopathic effect (CPE), the sensitivity and specificity of the PVLA method are 98% and 96%, respectively. Then, we tested the potential interference of NtAb against hepatitis A virus, Polio-I, Polio-II, and Polio-III standard antisera (WHO) and goat anti-G10/CA16 serum, the PVLA based assay showed no cross-reactivity with NtAb against other specific sera. Importantly, unlike CPE based method, no live replication-competent EV71 is used during the measurement. Taken together, PVLA is a rapid and specific assay with higher sensitivity and accuracy. It could serve as a valuable tool in assessing the efficacy of EV71 vaccines in clinical trials and disease surveillance in epidemiology studies.
URI http://hdl.handle.net/20.500.11897/190112
ISSN 1932-6203
DOI 10.1371/journal.pone.0064116
Indexed SCI(E)
PubMed
Appears in Collections: 医学部待认领

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