Abstract:
ObjectiveTwelve week sera specimens of vaccinees inoculated with live attenuated hepatitis A vaccine(H
2 strain)were tested for evaluating the effect of domestic HAVAB-E kits in detection.
MethodsTwo domestic HAVAB-E kits were produced by Institute of Medical Biology,CAMS,Kunming(Kunming-E)and Pukang Biotechnique Company, Zhejiang Provincial Academy of Medical Sciences.The HAVAB-IMx kits was bought from Abbott Laboratory,USA.IMx test system standardized with WHO reference preparation of HAV Ig was applied to determine antibody titers of mIU/ml.
ResultsThe GM T of 184 specimens was 27.2mIU/ml.Among them,167 samples(90.8%)showed titers>10mIU/ml.The result was quite close to protective efficacy offered by H
2 vaccine.The positive rates detected with 2 domestic kits were 95.1% (175/184,Kunming-E)and 90.2% (166/184,Zhejiang-E),respectively.However,the rate of accordant results derived from these 2 kits reached 92.9% (171/184).Positive rates of 2 domestic kits followed the rise of antibody level towards increase.With titer>20mIU/ml,the correspondence rate between the domestic kits and IMx kit was 94.4%98.1% (101-105/107).
ConclusionThe qualitative results provided by the domestic EIA diagnostic kits were reliable and could represent the immunogenicity and efficacy of live attenuated hepatitis A vaccine.