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- W2355961822 abstract "Objective To optimize some key items in testing method for final product of freezed-dried live attenuated hepatitis A vaccine.Methods Testing method for in fective titer:To establish micro-immunofluorescent method and compare its advantages with that of conventional cell culture ELISA method;Testing method for bovine serum protein residual content:To compare the reproducibility and accuracy between reverse indirect hemagglutination method and ELISA method;Testing method for water content:To establish method and the vaccine water content results were compared before and after solvent-aid adding.Results (1)The sensitivity of the micro-immunofluorescent method and conventional cell culture ELISA method was in same level(P0.05),but the former reproducibility was better.The results could be judged one week earlier;Leica Qwin fluorescence analysis software was helpful in getting standardization results.(2)The results of reverse indirect hemagglutination method were not stable,the variation coecficient value(CV) were 39.12% and 34.23% in two batches vaccine respectively(5 times testing).The accuracy and reproducibility of ELISA method we,re all better(CV 2.19%,2.82%,reclamation 101.73%).(3) The CV in two batches vaccine results were decreased from 8.32%,9.03% to 1.85%,1.82% respectively before and after the solvent-aid adding(5 times testing).Conclusion Micro-immunofluorescent method may replace the routine cell cultureELISA method in infective titer testing;ELISA method is better than reverse indirect hemagglutination method for bovine serum protein residual content testing ;The adding of solvent-aid can improve the reproducibility of water content testing." @default.
- W2355961822 created "2016-06-24" @default.
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- W2355961822 date "2006-01-01" @default.
- W2355961822 modified "2023-09-27" @default.
- W2355961822 title "Optimization of testing method for final product of freezed-dried live attenuated hepatitis A vaccine" @default.
- W2355961822 hasPublicationYear "2006" @default.
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