Dannacher G, Fédida M, Coudert M, Perrin M
Dev Biol Stand. 1976;35:271-8.
Innocuity testing in bovines remains the reference method but other methods using mice and especially cell cultures may be employed. Different techniques (dialysis, neutralization, elution, etc.) allow the elimination of toxic constituents of the vaccine while respecting the eventual presence of small quantities of active virus. The sensitivity of the cell cultures is certainly equal if not superior to that of the tongue of bovines. Interference phenomena do not intervene and, furthermore, there is not reason to fear them solely on cell cultures. From the purely statistical standpoint, it is hardly possible to prove the innocuity of a vaccine but the credit which sould be accorded to the innocuity test can be reinforced by a good control of the inactivation process and, a posteriori, by the repetition of negative results.
牛的无害性检测仍然是参考方法,但也可以采用其他使用小鼠尤其是细胞培养的方法。不同的技术(透析、中和、洗脱等)可在保留最终可能存在的少量活性病毒的同时,去除疫苗中的有毒成分。细胞培养的敏感性即便不比牛舌的敏感性更高,也肯定是相当的。不会出现干扰现象,而且,仅仅基于细胞培养也没有理由担心干扰现象。从纯粹统计学的角度来看,几乎不可能证明一种疫苗是无害的,但通过对灭活过程的良好控制以及事后重复出现阴性结果,可以增强对无害性检测的可信度。