Teaching and Scientific Research Center, School of Laboratory Medicine and Biotechnology, Southern Medical University, Guangzhou, China.
Institute of Antibody Engineering, School of Laboratory Medicine and Biotechnology, Southern Medical University, Guangzhou, China.
Sci Rep. 2017 Aug 4;7(1):7288. doi: 10.1038/s41598-017-07687-7.
Replacement of the in vivo rabies vaccine potency test (NIH test) by in vitro methods had been discussed by several researcher including WHO expert working groups. In this paper, a time-resolved fluoroimmunoassay (TRFIA) for the assay of rabies virus glycoprotein in rabies vaccine was first established to estimate the rabies vaccine potency by using specific monoclonal antibody that only recognized the native, trimeric and immunogenic form of rabies virus glycoprotein. Potency of the rabies virus glycoprotein was assayed with satisfactory performance under optimal conditions, and the method demonstrated satisfactory results when applied in practical samples. The correlation coefficient of potency values obtained from the present TRFIA and ELISA was 0.912, and 0.903 for those from the present TRFIA and NIH test. These preliminary results confirmed that this TRFIA can replace ELISA with higher performance, and could be a promising replacement of the NIH test. Based upon these results, the present TRFIA seemed to be a convenient tool for evaluating rabies vaccine potency and its products at different stages accordingly.
替代体内狂犬病疫苗效力检测（NIH 检测）的体外方法已被包括世界卫生组织专家工作组在内的多位研究人员讨论。本文首次建立了用于检测狂犬病疫苗中狂犬病病毒糖蛋白的时间分辨荧光免疫分析（TRFIA），该方法使用特异性单克隆抗体来评估狂犬病疫苗效力，该抗体仅识别狂犬病病毒糖蛋白的天然、三聚体和免疫原性形式。在最佳条件下，狂犬病病毒糖蛋白的效力通过该方法进行了令人满意的检测，并且该方法在实际样本中的应用也取得了令人满意的结果。本研究中的 TRFIA 和 ELISA 获得的效力值之间的相关系数为 0.912，TRFIA 和 NIH 检测之间的相关系数为 0.903。这些初步结果证实，该 TRFIA 可以替代 ELISA，具有更高的性能，有望替代 NIH 检测。基于这些结果，本研究中的 TRFIA 似乎是一种方便的工具，可以在不同阶段评估狂犬病疫苗效力及其产品。
