Establishment and application of domestic entirely automatic system of nucleic acid amplification testing in blood screening

Objective To establish domestic entirely automatic nucleic acid testing(NAT)assay for blood screening, and to study the feasibility of domestic NAT.Methods On the basis of enzyme linked immunosorbant assay for blood screen,blood samples were pooled and extracted nucleic acid with entirely automatic nucleic acid apparators, then the extracted nucleic acid was amplified and detected with real-time polymerase chain reaction,sensitivity and efficacy was evaluated,NAT positive donors were traced.Results The 95% detection limits of HBV DNA,HCV RNA and HIV-1 RNA tested by automatic system were 35.9 IU/mL,147.7 IU/mL and 66.1 IU/mL,respectively, 95% confidence intervals were[21.9,124.8],[93.3,386.4]and[38.8,235.3]respectively.Twelve of 60 112 samples were HBV DNA positive,DNA positive ratio was 1:5 009,6 of which were anti-HBc positive;one sample was HCV RNA positive,RNA positive ratio was 1:60 112;no HIV-1 RNA positive was detected among all sampies. Seven HBV DNA donors were followed up,4 of whom had seroconverted.Conclusion The domestic entirely automatic system can be applied in blood HBV DNA,HCV RNA and HIV RNA screening.