Abstract
Objective To establish a quantitative assay method for determining the titer of enterovirus 71(EV71)during its inactivated vaccine development and manufacturing.Methods By using a mouse anti-EV71 monoclonal antibody and rabbit anti-EV71 polyclonal antibodies,a sandwich ELISA method for EV71 inactivated vaccine was established.The sensitivity,specificity and reproducibility of the method were evaluated.Results A specific and sensitive ELISA method for quantitative assay of EV71 inactivated vaccine was developed.Its detection limit was determined to be 3.9352 log10TCID50/mL and its detection range was 3.9352-5.9686 log10TCID50/mL.Its correlation coefficient was R2 =0.9956.The method showed good sensitivity,specificity and reproducibility.It had no cross-reaction to samples other than EV71 and the variation co-efficient was lower than 7%.Conclusions A quantitative ELISA method is established for EV71 inactivated vaccine.It offers a useful and rapid way to determine the titer of EV71 inactivated vaccine during its developnent and production. Key words: Enzyme-linked immunosorbent assay; Enterovirus 71; Inactivated vaccine
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