组胺致敏试验(HIST)是一项用于无细胞百日咳疫苗批签发的致死性试验,或者是百日咳与其他疫苗联合应用的疫苗批签发的检测试验。这项试验需要使用大量的动物,并且该项试验难以标准化,因此迫切需要开发一种体外替代性试验以取代HIST。一项体外测定系统已经开发出来,用于替代HIST,以期测定百日咳毒素的功能性结构域,这是一项将酶联HPLC(E-HPLC)和碳水化合物结合测 The histamine sensitization test (HIST) is a lethal test used to aventise acellular pertussis vaccine, or a vaccine batch to be tested in combination with other vaccines. This test requires the use of a large number of animals, and the test is difficult to standardize, there is an urgent need to develop an alternative test in vitro to replace HIST. An in vitro assay system has been developed to replace HIST in order to determine the functional domain of pertussis toxin, an enzyme-linked HPLC (E-HPLC) and carbohydrate-binding assay