The reduction of animal usage by the application of indirect haemagglutination in the potency testing of diphtheria toxoid in combined vaccines

Journal of biological standardization Pub Date : 1988-01-01 DOI:10.1016/0092-1157(88)90024-8

S.C. Maheshwari , Suniti B. Sharma , Subhash Ahuja , S.N. Saxena

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引用次数: 5

Abstract

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.

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在联合疫苗白喉类毒素效价检测中应用间接血凝法减少动物使用量

采用英国药典(1973)的方法，对四家不同厂家生产的8种吸附白喉-破伤风疫苗和13种白喉-破伤风-百日咳疫苗在豚鼠体内白喉成分的效力进行了测试。通过间接血凝(IHA)和常规毒素中和(TN)试验，对210份豚鼠血清(与每种疫苗样品相关的10份血清)进行白喉抗毒素滴定。统计分析结果表明，两种试验得到的滴度具有良好的相关性。根据IHA试验测定的豚鼠血清抗毒素含量计算出的各种疫苗白喉成分的效力与常规TN试验测定的抗毒素含量所得出的效力显著相关。因此，使用IHA代替TN试验提供了一种可以减少动物使用的替代方法。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Journal of biological standardization

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