Stainer D W, Cameron J
Dev Biol Stand. 1977;34:149-53.
Reversion of toxoid to toxin has been described by several authors yet present day regulations of all National Control Authorities have no specific requirements to check for this possibility. Most producers however have included some form of test in their own protocols for release. We have developed a satisfactory test for both diphtheria and tetanus toxoids which involves storing diluted toxoid at 20 degrees C and 34 degrees C for 6 weeks and performing a full toxicity test on the samples. In the case of diphtheria toxoid we have evidence that it may be dangerous to rely on the simpler guinea-pig skin test, since we have shown that several lots, while giving a negative skin reaction, exhibit diphtheria toxicity when given systemically. It is felt that an in vivo conversion to toxin may occur in some lots which would not be detected by the skin test.
几位作者曾描述过类毒素向毒素的逆转情况，但目前所有国家监管当局的规定都没有针对检查这种可能性的具体要求。然而，大多数生产商在其自身的放行规程中都纳入了某种形式的检测。我们已经为白喉和破伤风类毒素开发出了一种令人满意的检测方法，该方法包括将稀释后的类毒素在20摄氏度和34摄氏度下储存6周，并对样品进行全面的毒性检测。就白喉类毒素而言，我们有证据表明依赖更简单的豚鼠皮肤试验可能存在危险，因为我们已经表明，有几个批次虽然皮肤试验呈阴性反应，但全身给药时却表现出白喉毒性。有人认为，在某些批次中可能会发生体内向毒素转化的情况，而皮肤试验无法检测到这种转化。
