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麻疹抗体的空斑减少中和试验：用于气溶胶疫苗免疫原性研究的标准化实验室方法说明

Plaque reduction neutralization test for measles antibodies: Description of a standardised laboratory method for use in immunogenicity studies of aerosol vaccination.

作者信息

Cohen Bernard J, Audet Susette, Andrews Nick, Beeler Judy

机构信息

Centre for Infections, Health Protection Agency, London NW9 5EQ, UK.

出版信息

Vaccine. 2007 Dec 21;26(1):59-66. doi: 10.1016/j.vaccine.2007.10.046. Epub 2007 Nov 12.

DOI:10.1016/j.vaccine.2007.10.046
PMID:18063236
Abstract

BACKGROUND

Clinical trials of measles vaccination administered as aerosol are planned with the aim of obtaining licensure. Measles antibody levels will be measured using the plaque reduction neutralization test (PRNT) to assess antibody responses as a surrogate marker of efficacy.

METHODS

A working group examined laboratory protocols for measles PRNT in use at three reference centres and agreed to a standardised procedure, which was subsequently validated.

RESULTS

Assay validation showed quantitative results varied approximately threefold both within and between assays. The lower limit of detection was approximately 20milliInternational Units/mL.

CONCLUSIONS

A standardised laboratory protocol for measles PRNT was established and validated for use in clinical trials of aerosolized measles vaccines.

摘要

背景

计划开展以气溶胶形式接种麻疹疫苗的临床试验，目的是获得许可。将使用蚀斑减少中和试验（PRNT）测量麻疹抗体水平，以评估抗体反应作为疗效的替代指标。

方法

一个工作组检查了三个参考中心使用的麻疹PRNT实验室方案，并商定了标准化程序，随后对该程序进行了验证。

结果

分析验证表明，定量结果在分析内和分析间的差异约为三倍。检测下限约为20毫国际单位/毫升。

结论

建立了标准化的麻疹PRNT实验室方案，并验证其可用于雾化麻疹疫苗的临床试验。

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