Preparation of national reference panel of HBV for nucleic acid testing donor screening / 中国生物制品学杂志

ABSTRACT

@#Objective To prepare the national reference panel of hepatitis B virus(HBV) for nucleic acid testing(NAT)donor screening.Methods A number of plasma samples from donors positive for HBV antibody and patients with HBV infection collected from blood centers,plasma stations and biological products companies in Shanghai,Gansu,Henan,Hunan,Hubei and other regions were tested for HBV DNA viral load agent,and negative and positive reference candidates were screened;The HBV DNA national standard was diluted to 10~3 IU/ml with human negative plasma,as a candidate for limit of detection(LOD).National negative and positive reference candidates of HBV for NAT donor screening and LOD reference to be calibrated were distributed to 8 enterprise laboratories for joint detection of HBVHCVHIV NAT donor screening.The homogeneity and stability of the national reference panel were investigated.Results A total of 8 negative samples with HBV viral load of 0 were screened as negative references and 9 positive samples with viral load of 10~3～10~4 IU/mL were used as positive references;One LOD reference was calibrated with WHO HBV DNA standard,and the virus content was 1.0 × 10~3 IU/ml.The national reference panel showed good stability and the homogeneity inspection met the requirements.Conclusion The national reference panel of HBV DNA for NAT donor screening was prepared,which provided a basis for the quality control and standardization of HBV DNA reagents for donor screening.