吸附破伤风疫苗血清学效价检测方法的建立及初步验证

Establishment and Preliminary Validation of Serological Potency Test Method for Adsorbed Tetanus Vaccines

目的建立吸附破伤风疫苗血清学效价检测方法并对其进行初步验证。方法通过对采血时间、有效剂量范围的选择,建立附破伤风疫苗血清学效价检测方法,在3个实验室对10批破伤风疫苗用小鼠攻毒法和本研究方法进行19次效价检测,对2种方法的检测结果进行初步验证。结果建立了吸附破伤风疫苗血清学效价检测方法。吸附破伤风疫苗小鼠攻毒法和本方法的重现性分别为16%和22%,破伤风三联疫苗两种方法的重现性分别为11%和5%,破伤风五联疫苗两种方法的重现性分别为48%和34%。配对t检验显示2种方法检测结果无统计学差异,Bland-Altman法显示2种方法具有较好的一致性。结论建立了吸附破伤风疫苗血清学效价检测方法,为血清学效价检测方法替代小鼠攻毒法提供了数据支持。

OBJECTIVE To establish a serological potency test method for adsorbed tetanus vaccines and validate it preliminarily. METHODS Based on the establishment of tetanus antibody in vitro binding enzyme-linked immunosorbent assay, a serological potency test method for tetanus vaccines was established by selecting the time of blood collection and the range of effective dose.The potencies of 10 batches of tetanus vaccine were tested 19 times by mice challenge method and serological potency method in three different laboratories. The reproducibility of the method was validated by CV, paired t-test was used for statistical analysis, and the consistency of the method was evaluated by Bland-Altman method. RESULTS The serological potency test method of adsorbed tetanus vaccines was established. The reproducibilities CVs of mice challenge method and serological potency method were 16% and 22% respectively for adsorbed tetanus vaccine, the reproducibilities CVs of the two methods were 11% and 5% respectively for adsorbed diphtheria tetanus and acellular pertussis combined vaccine, and the reproducibilities CVs of the two methods were 48% and 34% respectively for adsorbed diphtheria tetanus and pertussis poliomyelitis vaccine and haemophilus type b conjugate vaccine.Paired t-test showed that there was no significant difference between the results of the two methods. Bland Altman method showed that the two methods had good consistency. CONCLUSION The serological potency test method of adsorbed tetanus vaccine is established.The study provides data support for serological potency test method to replace mice challenge method.