Impacto de los cambios realizados en la etapa de multiplicación celular durante la obtención de la Sustancia Sensibilizante de Eritrocitos utilizada en el diagnóstico serológico de la Leptospirosis.

Introduction: In Cuba since 1981 has implemented the indirect hemagglutination as an alternative technique of Leptospirosis diagnosed, in the absence of others that may be more costly but effective at different stages of the disease. For the development of the technique requires the Erythrocytes Sensitize Substance (ESS), assuming the production Finlay Institute in 2009, from obsolete technology in the process of cell multiplication. Objective: The aim of this study was to make changes at this stage to obtain the ESS with the culture media available at the plant for optimum product performance, without affecting the biological activity as the basic parameter of quality. Methods: Eight experimental groups were formed according to multifactorial design, taking into account: production strain (LABIOFAM or Finlay strain of L. biflexa Patoc I), culture medium (MK and MEJH) and culture conditions (static or agitated). Results and conclusion: We obtained as a result that the best variant was the combination (LABIOFAM strain, growth in MEJH and agitated), with a considerable decrease in the time of the ESS obtaining by means of this new technology, with a consistent title with the demands of quality. This work allowed to use the best variant to begin the different designs of stability studies of the product.