New approach for determination of the identity of the combined vaccines for diphtheria, tetanus and pertussis prophylaxis

Special diagnostic preparations based on a staphylococcal reagent containing protein A, and affinity-purified antibodies have been developed for the purpose of identifying pertussis antigens, tetanus and diphtheria toxoids in the coagglutination test. The coagglutination reaction is informative and easy to perform; it can be recommended to be included into specifications and technical documentation on combined vaccines, which makes it possible for the vaccine producer to harmonize verification methods of acquiring identity index to meet the European Pharmacopoeia requirements.