Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming 650118, China.
OBJECTIVE: To establish an quick, sensitive and specific assay for effective inactivatian test of inactivated hepatitis A vaccine. METHODS: effective inactivatian test of inactivated hepatitis A vaccine were carried out using integrated cell culture/strand-specific RT-PCR (ICC/strand-specific RT-PCR) assay compared with traditional ELISA and nest RT-PCR assay. RESULTS: all the samples were infectious negative detecting by both ICC/ strand-specific RT-PCR and ELISA assay,while some samples appeared false positive detecting by nest RT-PCR. CONCLUSION: ICC/strand-specific RT-PCR assay is a novel, rapid, sensitive and reliable method for effective inactivatian test of inactivated hepatitis A vaccine. Shorting detection period largely, this assay may be used as an alternative method for routine inactivated hepatitis A vaccines test.