RESUMO
The fraction composition of tetanus antitoxic sera has been studied by the method of gel filtration in columns packed with Sephadex G-200. Differences in the fraction composition of preparations manufactured by different enterprises have been revealed. The specific activity of antitoxic sera has been found to depend on the degree of their fragmentation.
Assuntos
Antitoxina Tetânica/análise , Cromatografia em Gel , Fragmentos Fab das Imunoglobulinas/análise , Peso Molecular , Controle de Qualidade , Antitoxina Tetânica/isolamento & purificação , Antitoxina Tetânica/normasRESUMO
A method for the screening of human sera for tetanus antibodies has been developed and evaluated. The toxin binding inhibition test (ToBI-test) is based on inhibition of the binding of tetanus toxin to an antitoxin-coated immunoassay microtitre plate by tetanus antibodies. Serum samples from 191 healthy adults with different vaccination histories have been titrated for tetanus antibodies by the toxin neutralization (TN) test in mice, by toxoid-ELISA and by the ToBI-test. In every respect, the ToBI-test proved to be the best in vitro alternative to the TN-test in mice. Comparisons showed a higher degree of correlation between the ToBI-test and the TN-test than between the toxoid-ELISA and the TN-test. Furthermore, no overestimation of antibody content was seen in titrating low titre sera by the ToBI-test. In contrast, several false positive results were seen when using the toxoid-ELISA. It is concluded that the ToBI-test is a reliable and precise alternative to the TN-test and can be performed under simple laboratory conditions in a short time.
Assuntos
Imunoensaio/métodos , Antitoxina Tetânica/análise , Animais , Ensaio de Imunoadsorção Enzimática , Estudos de Avaliação como Assunto , Humanos , Técnicas In Vitro , Camundongos , Testes de Neutralização , Antitoxina Tetânica/normas , Toxina TetânicaRESUMO
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.
Assuntos
Testes de Floculação , Antitoxina Tetânica/normas , Inglaterra , Testes de Neutralização , Farmacopeias como Assunto , Padrões de ReferênciaRESUMO
The papers present the results of a survey of the usage, assay and specification of veterinary clostridial sera and vaccines in 23 countries. Thirteen of the countries use up to 8 different antisera. All the countries use vaccines, which are prepared from 13 species and types of clostridia. Vaccines containing up to 8 such components are commonly employed. Criteria for the design and interpretation of assays are discussed and evidence for efficacy summarized.
Assuntos
Antitoxinas/normas , Vacinas Bacterianas/normas , Clostridium/imunologia , Animais , Toxinas Bacterianas/normas , Antitoxina Botulínica/normas , Clostridium botulinum/imunologia , Clostridium perfringens/imunologia , Clostridium tetani/imunologia , Cobaias , Camundongos , Antitoxina Tetânica/normasAssuntos
Especificidade de Anticorpos , Antitoxina Tetânica/isolamento & purificação , Adsorção , Animais , Proteínas Sanguíneas/análise , Bovinos/imunologia , Fracionamento Químico , Cabras/imunologia , Cavalos/imunologia , Humanos , Soros Imunes , Imunoeletroforese , Pepsina A , Coelhos/imunologia , Soroglobulinas , Ovinos/imunologia , Testes Cutâneos , Antitoxina Tetânica/normas , Toxoide Tetânico , gama-GlobulinasRESUMO
Since 1935 the International Unit for Tetanus Antitoxin has been defined as the activity contained in a certain weight of the first International Standard for Tetanus Antitoxin. As stocks of this standard had become depleted, 11 laboratories in 8 countries were requested to participate in a collaborative assay of a preparation proposed as a replacement.The assay results were analysed and presented to the WHO Expert Committee on Biological Standardization in 1969 which established the preparation studied as the second International Standard for Tetanus Antitoxin and defined the International Unit for Tetanus Antitoxin as the activity contained in 0.03384 mg of the second International Standard for Tetanus Antitoxin. This definition would ensure the continuity of the size of this international unit.The analysis of the collaborative studies also showed that the second International Standard for Tetanus Antitoxin has suitable properties for use in the flocculation test for the determination of the antigen content of tetanus toxoids in Lf values. The designation Lf-equivalent is described and the problems relating to the use of this term for the expression of results of in vitro assays are analysed in relation to the use of international units for expressing results of in vivo assays. As the second International Standard for Tetanus Antitoxin has an in vivo/in vitro ratio of 1.4, the Lf-equivalent of this antitoxin is 1.4 times less than its unitage.
