核酸检测在筛查献血者乙型肝炎病毒中的应用

Application of NAT in the screening of hepatitis B virus among blood donors

目的通过血清学检测和核酸检测并行的检测模式,合理评估核酸检测技术(NAT)应用于毕节市无偿献血血液筛查中的必要性。方法采用2种酶联免疫吸附(ELISA)试剂对2016年1月—2017年12月在毕节市采集的无偿献血者标本进行HBs Ag检测,对酶免检测无反应性和单试剂有反应性标本做核酸检测。部分核酸有反应性样本送国家卫生健康委确认。结果2016—2017年共采集血液标本56798份,酶免双试剂有反应性标本557份。HBs Ag酶免检测有反应性标本347份,其中单试剂有反应性标本86份,双试剂有反应性标本261份。核酸检测标本56241份,经核酸检测混检有反应性pool数为54,拆分有反应性数为27份,均为HBV DNA有反应性。核酸有反应性检出率为0.48‰。酶免单试剂检测有反应性且核酸检测有反应性样本为2份。6份核酸检测有反应性标本经卫生部临检中心确认,3份标本为HBV DNA确认有反应性,6份标本均为HBc Ab有反应性。结论核酸检测能够检出HBs Ag阴性的乙肝感染者,减少乙肝经输血传播的风险。

Objective To evaluate the necessity of nucleic acid testing(NAT)for blood screening among voluntary blood donors in Bijie city,using the parallel detection mode of serological assay and NAT.Methods Two kinds of enzymelinked immunosorbent assay(ELISA)kits were used to detect HBs Ag in voluntary blood donor samples collected in Bijie city from January 2016 to December 2017.The samples with serologically nonreactive results or reactive(R)results by single reagent were further detected by hepatitis B virus(HBV)NAT.Part of NAT reactive samples were confirmed in the National Center for Clinical Laboratories(NCCL).Results A total of 56798 blood plasma samples were collected by Bijie Central Blood Station during 2016 and 2017,of which 347 were screened as HBs Ag reactive,i.e.86 samples with single R and 261 samples with double R-R.56241 donations were screened by HBV NAT,27 were HBV NAT R,and the rate of HBV NAT R was 0.48‰.Among 86 single ELISA R samples,only two were NAT R.6 NATR samples were sent to the NCCL for further confirmation,all the samples were detected as HBV core antibody(HBc Ab)reactive,and 3 samples were confirmed as HBV DNA positive.Conclusion Nucleic acid testing can detect HBs Ag negative hepatitis B infection,reducing the risk of transmission of hepatitis B through blood transfusion.