HBV核酸血筛试剂国家参考品的研制

Preparation of national reference panel of HBV for nucleic acid testing donor screening

目的研制乙型肝炎病毒(hepatitis B virus,HBV)核酸血筛试剂国家参考品。方法将从上海、甘肃、河南、湖南、湖北等地域的血液中心、浆站、生物制品公司等收集到的多份人HBV抗体阳性或HBV感染者血浆样品,经HBV DNA病毒检测,筛选出阴性及阳性参考品候选品;将HBV DNA国家标准品用人阴性血浆稀释至10^(3)IU/mL,作为最低检出量(limit of detection,LOD)候选品。将HBV核酸血筛国家阴性及阳性参考品候选品、LOD参考品待标品分发至8家企业实验室,分别进行HBVHCVHIV核酸血筛联检测定。对整套国家参考品进行均匀性和稳定性考察。结果共筛选出8份HBV病毒载量为0的阴性样品,作为阴性参考品;9份HBV DNA病毒载量为10^(3)~10^(4)IU/mL的阳性样品,作为阳性参考品;1份LOD参考品,经WHO HBV DNA标准品标定,病毒含量为1.0×10^(3)IU/mL。整套国家参考品稳定性好,均匀性检查符合规定。结论制备了HBV核酸血筛试剂国家参考品,为我国HBV核酸血筛试剂的质量控制和标准化提供了依据。

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.