Establisment of a sensitivity panel for quality control of HBsAg diagnostic kits in Vietnam

Abstract

According to WHO, HBsAg diagnostic kits circulating in marker should have limit of detection under 4 IU/ml. We sucessfully established a sensitivity panel from 3 HBsAg positive plasmas that were identifed as genotype B, genotype C and recombinant B+C.  These genotypes are commonly found in Vietnam. The sesitivity panel contains 18 positive members ranged from 0,1-10U/ml. The panel was evaluated for stability at 4oC for 21 days. The results showed no significant difference in HBsAg concentrations of 18 members for 21 days, that could predict a stability of at least one year under the recommended storage condition (-40⁰C). The panel was used to validate sensitivity level of 06 HBsAg diagnostic kits.  CCLA, Realtime PCR and ELISA showed 100% positve rate on 18 members while the two rapid tests showed 16,7%. These results indicate our newly established sentitivity panel can serve as a good tool for quality control of HBsAg diagnostic kits in Vietnam.