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验证一种酶联免疫吸附测定法，用于定量检测人体针对寄生虫疟原虫裂殖子表面蛋白重复区的 IgG 抗体。

Validation of an enzyme-linked immunosorbent assay for the quantification of human IgG directed against the repeat region of the circumsporozoite protein of the parasite Plasmodium falciparum.

机构信息

Center for Vaccinology, Ghent University, Ghent, Belgium.

出版信息

Malar J. 2012 Nov 22;11:384. doi: 10.1186/1475-2875-11-384.

DOI:10.1186/1475-2875-11-384
PMID:23173602
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3577486/
Abstract

BACKGROUND

Several pre-erythrocytic malaria vaccines based on the circumsporozoite protein (CSP) antigen of Plasmodium falciparum are in clinical development. Vaccine immunogenicity is commonly evaluated by the determination of anti-CSP antibody levels using IgG-based assays, but no standard assay is available to allow comparison of the different vaccines.

METHODS

The validation of an anti-CSP repeat region enzyme-linked immunosorbent assay (ELISA) is described. This assay is based on the binding of serum antibodies to R32LR, a recombinant protein composed of the repeat region of P. falciparum CSP. In addition to the original recombinant R32LR, an easy to purify recombinant His-tagged R32LR protein has been constructed to be used as solid phase antigen in the assay. Also, hybridoma cell lines have been generated producing human anti-R32LR monoclonal antibodies to be used as a potential inexhaustible source of anti-CSP repeats standard, instead of a reference serum.

RESULTS

The anti-CSP repeats ELISA was shown to be robust, specific and linear within the analytical range, and adequately fulfilled all validation criteria as defined in the ICH guidelines. Furthermore, the coefficient of variation for repeatability and intermediate precision did not exceed 23%. Non-interference was demonstrated for R32LR-binding sera, and the assay was shown to be stable over time.

CONCLUSIONS

This ELISA, specific for antibodies directed against the CSP repeat region, can be used as a standard assay for the determination of humoral immunogenicity in the development of any CSP-based P. falciparum malaria vaccine.

摘要

背景

几种基于恶性疟原虫环子孢子蛋白（CSP）抗原的早期红细胞疟疾疫苗正在临床开发中。疫苗免疫原性通常通过 IgG 为基础的检测方法来测定抗 CSP 抗体水平来评估，但没有标准的检测方法可以比较不同的疫苗。

方法

描述了一种抗 CSP 重复区酶联免疫吸附试验（ELISA）的验证。该检测方法基于血清抗体与 R32LR 的结合，R32LR 是一种由恶性疟原虫 CSP 重复区组成的重组蛋白。除了原始的重组 R32LR 外，还构建了一种易于纯化的重组 His 标记的 R32LR 蛋白，用作检测中的固相抗原。此外，还产生了杂交瘤细胞系，产生人抗 R32LR 单克隆抗体，作为抗 CSP 重复标准的潜在无尽来源，而不是参考血清。

结果

抗 CSP 重复 ELISA 显示出稳健性、特异性和线性，在分析范围内，并且充分满足 ICH 指南中定义的所有验证标准。此外，重复性和中间精密度的变异系数不超过 23%。R32LR 结合血清未发生干扰，并且该检测方法在一段时间内是稳定的。

结论

这种特异性针对 CSP 重复区抗体的 ELISA 可用于测定任何基于 CSP 的恶性疟原虫疟疾疫苗开发中的体液免疫原性的标准检测方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8ce/3577486/43b9e3a0907e/1475-2875-11-384-5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8ce/3577486/ec3badbe52bb/1475-2875-11-384-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8ce/3577486/27621876352c/1475-2875-11-384-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8ce/3577486/a558d4d86360/1475-2875-11-384-3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8ce/3577486/e261d9a6b3a0/1475-2875-11-384-4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8ce/3577486/43b9e3a0907e/1475-2875-11-384-5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8ce/3577486/ec3badbe52bb/1475-2875-11-384-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8ce/3577486/27621876352c/1475-2875-11-384-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8ce/3577486/a558d4d86360/1475-2875-11-384-3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8ce/3577486/e261d9a6b3a0/1475-2875-11-384-4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8ce/3577486/43b9e3a0907e/1475-2875-11-384-5.jpg

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