The quantitative estimation of diphtheria and tetanus toxoids. 1. The flocculation test and the Lf-unit

Considerable confusion exist in the quantitative estimation of diphtheria and tetanus toxoids. The present paper is the first in a series of papers comparing various quantitative methods. It describes the flocculation test, gives a mathematical model for the three-dimensional reaction surface, and suggests different designs which facilitate the unbiased calculation of the end-point.     

The British Reference preparation for tetanus antitoxin for the flocculation test

To facilitate the quality control of tetanus toxoids used in the formulation of adsorbed vaccines, an equine antitetanus serum has been extensively assayed and established as the British Reference preparation for tetanus antitoxin for the flocculation test.     

絮状单位测定与小鼠体内中和试验法检测TAT效价的比较

目的为了更好地进行生产质量控制,快速准确地测定破伤风抗毒素(TAT)效价,以统计分析絮状单位测定法(体外法)和小鼠中和试验法(体内法)测定TAT效价的相关性。方法对2010—2013年破伤风抗毒素生产过程中的原料血浆、原液的絮状单位值与小鼠中和效价进行了统计分析和比较。结果体外法和体内法检测TAT原料血浆和原液效价的相关系数分别为r血浆=0.794 3,P0.001和r原液=0.901 6,P0.001,均呈显著性正相关。结论体外法可指导或替代体内法TAT效价测定应用于生产过程中间品的质量控制。