狂犬病疫苗效力试验ELISA法-平行线分析法

Rabies vaccine potency test with parallel line bioassay method by ELISA

建立ＥＬＩＳＡ方法测定狂犬病疫苗效力，用酶标记狂犬病毒糖蛋白单克隆抗体检测包被的疫苗抗原，用平行线分析法计算制品相对效力。在２８个疫苗样品中ＥＬＩＳＡ法与ＮＩＨ法测定效力获得的结果无明显差异（Ｐ＞０．５）。所用单克隆抗体和疫苗为同一病毒糖蛋白的抗原。抗体反应，具有高度特异性，疫苗测定低限为０．００９ＩＵ／ｍｌ。试验间变异率为６．２９％。

We adopted the in vitro ELISA to test the potency of inactivated hamster kidney cell culture rabies vaccine. The relative potency was determined hy the parallel line bioassay in which the potency of the vaccine to be tested was compared with that of reference preparation on a single microtitre plate. The glycoprotein content was measured quantitatively.The potency determined by the in vitro ELISA correlated with it vivo NIH potency test. The lowest detection limit of the in vitro ELISA was 0. 009IU, Coefficient of variation (CV) was 6. 29% with good reproducibility. It was possible to use this in vitro ELISA to assay the final vaccine with adjuvant and/or nonadjuvant as well as the products in proess such as tissue culture supernatants with live or inactivated rabies virus, the concentrates and vaccine undergoing thermal stability test.