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目的建立检测联合疫苗中白喉类毒素残余毒性的新方法,以替代现有的家兔皮肤试验法。方法采用Vero细胞法检测白喉类毒素的残余毒性,对该方法的特异性、灵敏度(最低检测限)和重复性进行验证,并对Vero细胞法与家兔皮肤试验法测定白喉类毒素残余毒性的结果进行比较。结果 Vero细胞可特异性检测白喉类毒素的残余毒力,该方法的最低检出限为10-8 LD50白喉毒素,重复性良好,灵敏度比家兔皮肤试验法高10 000倍。结论 Vero细胞法可用于白喉类毒素残余毒性检查和毒性逆转检查,该方法特异性强,灵敏度高于家兔皮肤试验法,适用于以白喉、破伤风为基础的联合疫苗(DT-based combined vaccines,DT combos)的安全性评价。
Objective To establish a new method to detect the residual toxicity of diphtheria toxoid in the combination vaccine to replace the existing rabbit skin test. Methods The residual toxicity of diphtheria toxoid was detected by Vero cell method. The specificity, sensitivity (minimum detection limit) and repeatability of the method were verified. The residual toxicity of diphtheria toxoid was determined by Vero cell method and rabbit skin test The results are compared. Results Vero cells could detect the residual virulence of diphtheria toxoid. The detection limit of this method was 10-8 LD50 diphtheria toxin with good reproducibility and sensitivity of 10,000 times higher than that of rabbit skin test. Conclusions The Vero cell method can be used for the residual toxicity test and toxicity reversal test of diphtheria toxoid. The method is more specific and sensitive than the rabbit skin test and is suitable for the combination of diphtheria and tetanus-based combination vaccines (DT-based combined vaccines , DT combos) safety evaluation.