甲型肝炎减毒活疫苗检定方法精确度的探讨

Accurary of Titration Method for Detecting Live Attenuated Hepatitis A Vaccine

目的 提高甲肝减毒活疫苗检定方法的精确度。方法 比较不同刑量组与剂量组不同的试验数，以 及采用点斜法与Ｒｅｅｄ－Ｍｕｅｎｃｈ法计算ＴＣＩＤ５０。结果 通过比较４种不同的试验设计，发现随着稀释倍数减小或／和各 稀释度试验管数增加，ＴＣＩＤ５０的标准误减小，以减小稀释倍数同时增加各稀释度试验管数，其标准误的缩小最为明显。 点斜法计算的ＩＣＩＤ５０９５％可信区间较Ｒｅｅｄ－Ｍｕｅｎｃｈ法为窄。结论 减小稀释倍数同时增加各稀释度试验管数，并采 用点斜法计算ＴＣＩＤ５０，能使疫苗检定方法的精确度满足规范化甲肝活疫苗滴定的要求。

Objective To increase the accuracy of titration method for detecting live attenuated hepatitis A vaccine. Methods The accuracy of various dosage groups,as well as various tubes in every group, were corn-pared. The TCID50 values calculated by modified Karber' s and Reed - Muench' s methods were also compared. Results Along with the decrease of dilution fold and/or the increase of tubes in each dilution,the stadnard error of TCID50 decreased. The 95% confidence interval of TCID50 calculated by modified Karber' s method was smaller than that by Reed - Muench' s method. Conclusion The accuracy can meet the requirements for the standard titration of live hepatitis A vaccine by decreasing dilution fold and increasing the tubes of each dilution at the same time.