Maheshwari S C, Sharma S B, Ahuja S, Saxena S N
Division of Biological Standardization and Quality Control, Central Research Institute, Kasauli, India.
J Biol Stand. 1988 Jan;16(1):9-14. doi: 10.1016/0092-1157(88)90024-8.
Eight Adsorbed Diphtheria-Tetanus vaccines and 13 Diphtheria-Tetanus-Pertussis vaccines made by four different manufacturers were tested for the potency of the diphtheria components in guinea-pigs by the method of British Pharmacopoeia (1973). Two-hundred-and-ten guinea-pig sera consisting of ten sera related to each vaccine sample thus obtained were titrated for diphtheria antitoxin by indirect haemagglutination (IHA) and the conventional toxin neutralization (TN) tests. Statistical analysis of the results showed a good correlation between the titres obtained with the two tests. The potencies of the diphtheria components of various vaccines calculated from the antitoxin content of the respective guinea-pig sera titrated by the IHA test correlated significantly with the potencies obtained from the antitoxin content titrated by the routinely used TN test. The use of IHA in place of the TN test thus offers as an alternative that permits a reduction in animal usage.
采用英国药典（1973年版）方法，对4家不同制造商生产的8种吸附白喉-破伤风疫苗和13种白喉-破伤风-百日咳疫苗进行了豚鼠白喉成分效力测试。由此获得的每种疫苗样品相关的10份血清，共210份豚鼠血清，通过间接血凝试验（IHA）和传统毒素中和试验（TN）对白喉抗毒素进行滴定。结果的统计分析表明，两种试验获得的效价之间具有良好的相关性。根据IHA试验滴定的各豚鼠血清抗毒素含量计算的各种疫苗白喉成分效力，与常规使用的TN试验滴定的抗毒素含量获得的效力显著相关。因此，使用IHA代替TN试验提供了一种减少动物使用量的替代方法。
