Individual Donation Nucleic Acid Test Using Procleix TIGRIS System

Objective Nucleic acid testing(NAT)by Procleix ULTRIO Assay and ProcleixTIGRIS System was used to screen blood donations for HBV,HCV,HIV,so as to get the leakage of serologic screening.Individual donation NAT(ID-NAT)format and minipools NAT(MP-NAT)format were compared as well.Methods ID-NAT by Procleix ULTRIO Assay and twice ELISAs were simultaneously proceeded.ULTRIOpositive specimens were respectively discriminated and experienced simulative minipools of 8 and 16 NAT(MP-8-NAT and MP-16-NAT).Results Among 10 064 specimens,10 were found ELISA negative while ID-NAT positive and identified as HBV DNA positive carriers.The leakage of HBV serologic screening was up to 0.99‰.28 both ELISA and ID-NAT positive specimens were also found,among which 6 were HCV and 22 were HBV carriers.These 28 both ELISA and ID-NAT positive specimens and 10 ELISA negative while ID-NAT positive specimens were diluted to simulate minipools of 8 and 16 NAT.Their positive rates of MP-8-NAT and MP-16-NAT compared to ID-NAT were respectively 78.6%,75.0% and 30.0%,20.0%.Conclusion Twice ELISA-format had a high leakage of HBV.ID-NAT shows higher sensitivity than MP-NAT,especially for ELISA negative while ID-NAT positive specimens.