Immunoagglutination Test Using Monoclonal Antibodies Coupled to Latex Particles to Identify The Streptococcus Pneumoniae Capsular Polysaccharides Serotype 1, 5, 6B, 14 And 19F In Quimi-Vio Vaccine

Aims: To identify the PsC 1,5,6B,14,19F present in the Quimi-Vio vaccine by Immunoagglutination technique using in house Latex Reagents. Introduction: Two types of pneumococcal vaccines have been approved for use in humans. All use the capsular polysaccharide (PsC), as a vaccine antigen, conjugated or not. Quimi-Vio, the Cuban pneumococcal vaccine, is composed by seven PsC (1,5,6B,14,18C,19F,23F)all conjugated to Tetanus Toxoid. The identification of these PsCs in the vaccine formulation is a mandatory requirement for the final lots release. Materials and methods: Latex reagents were obtained by passive adsorption of monoclonal antibodies (MAbs) against PsC of serotypes 1,5,6B,14 and 19F to latex particles of 0.8 μm. Three concentrations of MAbs (100, 200 and 500 μg/mL) were evaluated for coupling. To each coupling variant was determined the percent coupling, the performance and specificity. The best variant was used to identify the PsCs present in three batches of Quimi-Vio vaccine. Results: The best variant of latex reagent was the one that employed the concentration of 200 μg/mL of MAb for coupling, presented 100% of coupling, a response of three crosses and a high specificity, for all serotypes. This variant was selected to carry out the identity test, where all latex reagents from each serotype identified the homologous PsC, in the context of Quimi-Vio and Prevenar 13V vaccine. Conclusions: The immunoagglutination technique using in house latex reagents using MAb, permit to identify specifically each PsC in the multivalent formulation, so it can be used for the Quimi-Vio identity test, thus guaranteeing batch release and quality control. Keywords: Immunoagglutination; Identity Assay; Pneumococcal Vaccines; Monoclonal Antibodi