A WHO Collaborative study on assays of the antigenic content of inactivated poliovirus vaccines.

摘要: In the first phase of a two part WHO Collaborative study, fourteen laboratories from ten countries estimated antigenic content six trivalent inactivated poliovirus vaccine preparations using in vitro methods. All used candidate standard method for D antigen assay (method A) and eight contributed results established 'in-house' methods B). assayed an capture ELISA format. Monoclonal antibodies were as detector reagents A some B. The average difference potency estimates duplicate C was to assess within variation. Overall this found be 22% 19% B respectively. Within laboratory variation measured geometric coefficient between repeatability. Results B, 28% 26% respectively again very similar. Variation range 2- 5-fold most samples irrespective used. However, maximum 24-fold occurred when all taken into account. Method gave significantly enhanced type 3 component preparation shown immunogenic humans clinical trials, compared also failed F which prepared by inactivation Sabin strain poliovirus. Further work is required identify monoclonal antibodies, or combinations suitable universal application assays vaccines. improve control antigen-capture laboratories. second Study evaluated proficiency vivo assays. These together with evaluation correlation immunogenicity plus assessment reference materials will reported separately.