核酸检测技术在淮北地区无偿献血血液筛查中的应用  

Application of Nucleic Acid Testing Technology in Screening of Voluntary Blood Donation in Huaibei Area

作　　者：陈林 CHEN Lin(Department of Laboratory,Huaibei Central Blood Station,Huaibei Anhui 235000,China)

机构地区：[1]淮北市中心血站检验科,安徽淮北235000

出　　处：《中国卫生标准管理》2025年第2期167-170,共4页China Health Standard Management

摘　　要：目的 比较淮北地区无偿献血者血液标本酶联免疫吸附试验(enzyme-linked immunosorbent assay,ELISA)和核酸检测(nucleic acid testing,NAT)结果,分析2种方法联合检测的适用性。方法 选取淮北市中心血站检验科2019年1月—2021年1月接受检测的35 426份无偿献血者血液标本作为研究对象。血液标本均进行2遍ELISA检测,筛查乙型肝炎表面抗原(hepatitis B surface antigen,HBsAg)、丙型肝炎病毒抗体(hepatitis C virus antibody,抗-HCV)、人免疫缺陷病毒抗体(human immunodeficiency virus antibody,抗-HIV)。对2遍ELISA筛查阴性和单试剂检测阳性标本进行6混样37、HCV-RNA和HIV-RNA核酸检测,对检出有反应性的混样池(Pool)进行拆分检测。比较ELISA及NAT检测的乙型肝炎病毒(hepatitis B virus,HBV)、丙型肝炎病毒(hepatitis C virus,HCV)、人类免疫缺陷病毒(human immunodeficiency virus,HIV)筛查结果,统计ELISA与NAT的符合率及ELISA的漏诊率。结果 35 426份无偿献血者血液标本中,ELISA阴性标本34 653份、ELISA单试剂检测阳性78份,合计34 731份进行NAT检测。ELISA及NAT在HBV、HCV、HIV项目检测中结果一致性分析,差异无统计学意义(κ<0.001,P> 0.05)。ELISA单阳78份与NAT阳性符合率为0。ELISA阴性标本经NAT检测阳性27份,ELISA检测HBV、HCV、HIV的漏诊率分别为0.080%、0、0.003%。结论 核酸检测能有效缩短血液病毒的“窗口期”,降低ELISA误诊及漏检率,ELISA与NAT联合检测能进一步提高血液安全。Objective To compare the results of enzyme-linked immunosorbent assay(ELISA)and nucleic acid testing(NAT)on blood samples of voluntary blood donors in Huaibei region,and analyze the applicability of the combined detection of the two methods.Methods A total of 35426 blood samples from voluntary blood donors were collected and tested by the Laboratory of Huaibei Central Blood Station from January 2019 to January 2021 as the research subjects.Blood samples were subjected to two rounds of ELISA testing to screen for HBsAg,anti HCV,and anti HIV.Six mixed samples of deoxyribonucleic acid of hepatitis B virus(HBVDNA)、Hepatitis C virus RNA quantification(HCV-RNA)and human immunodeficiency virusribonucleic acid(HIV-RNA)nucleic acid were tested on samples that were negative for ELISA screening twice and positive for single reagent testing.Reactive pools were split and tested.The screening results of HBV,HCV,and HIV detected by ELISA and NAT were compared.The coincidence rate between ELISA and NAT,as well as the missed diagnosis rate of ELISA were statistically analyzed.Results Out of 35426 blood samples from voluntary blood donors,34653 were ELISA negative and 78 were ELISA single reagent positive,totaling 34731 were tested for NAT.Consistency analysis of ELISA and NAT results in HBV,HCV and HIV item detection the difference was not statistically significant(k=0.001,P>0.05).The coincidence rate between 78 ELISA single positive samples and NAT positive samples was 0.A total of 27 ELISA negative samples were tested positive by NAT,and the missed diagnosis rates of HBV,HCV,and HIV detected by ELISA were 0.080%,0,and 0.003%.Conclusion Nucleic acid testing can effectively shorten the“window period”of blood viruses,reduce the misdiagnosis and missed detection rates of ELISA,and the combined detection of ELISA and NAT can further improve blood safety.

关 键 词：无偿献血者 血液标本 酶联免疫吸附试验 核酸检测 病毒 血液安全 

分 类 号：R446[医药卫生—诊断学]