RESUMEN
@#Objective To evaluate the influence of three kinds of software on the statistical results of titer detection of diphtheria tetanus acellular pertussis(DTaP)vaccine,so as to provide a basis for the selection of analysis software in daily detection. Methods The titers of pertussis,tetanus and diphtheria of DTaP vaccine were detected by the method specified in Chinese Pharmacopoeia(volume Ⅲ,2020 edition). PLA 3.0 software,Stati software and Excel calculation table compiled according to the General Rules 1431 Biological Verification Statistical Method(General Rules 1431)of Chinese Pharmacopoeia(volume Ⅲ,2020 edition)were used for the data statistics of the titer detection of DTaP vaccine,and the relative titer value was calculated. The 95% confidence limit interval of the above data was determined by using the mass reaction parallel line method,and the relative deviation was calculated. Results The relative titers of pertussis of DTaP vaccine calculated by three kinds of software were 99. 16%-100. 46%,and the relative deviations of 95% confidence interval were all less than 3%. The relative titers of tetanus ranged from 99. 67% to 100. 46%,with all the relative deviations of 95% confidence interval of less than 1%. The relative titers of diphtheria ranged from 97. 33% to 100. 03%,the relative deviations of the upper bound of 95% confidence interval were all less than 0,but those of the lower bound were large. Conclusion The three kinds of software can replace each other,among which Stati software and General Rules 1431 software are more suitable for some work scenarios without audit trail requirements,while PLA 3.0 software is more suitable for the quality control system in biological products enterprises.