摘要
目的探讨核酸检测(nucleic acid test,NAT)技术应用于温州地区无偿献血者血液检测的功效。方法采用两遍酶免(ELISA)一遍NAT策略,剔除ELISA双试剂呈反应性和ALT检测不合格的样本后,进行HBV-DNA/HCVRNA/HIV-RNA 3联6混样NAT。混样结果呈反应性样本再行单人份拆分检测。结果2015年-2018年NAT共检测323196份样本,混检呈反应性607个pool(6人份混样池),单人份拆分呈反应性389例,拆分阳性率为64.09%,NAT总检出率为0.12%。随着混检反应性pool的循环阈值(Ct)增大,拆分阳性率下降,且不同Ct值间拆分阳性率差异有统计学意义(χ2=140.3,P=0.000)。2015年-2018年各年度间NAT总检出率差异无统计学意义(χ2=2.149,P=0.542)。ELISA结果均呈无反应样本NAT总检出率(0.11%)显著低于双试剂灰区、单试剂阳性(或者灰区)样本NAT总检出率(9.49%)(χ2=316.00,P=0.000)。结论目前温州地区NAT血液中存在的输血传播疾病风险主要源自HBV。应用NAT技术可有效保障血液安全。
Objective To investigate the efficacy of nucleic acid test(NAT)in blood detection of voluntary blood donors in Wenzhou area.Methods Using two-pass enzyme immunoassay(ELISA)and one-pass NAT strategy,HBV-DNA/HCV-RNA/HIV-RNA 3-plex 6-mix NAT was performed after excluding samples that were reactive in ELISA double reagent and failed in ALT test.The mixed samples showed reactive results,and then the samples were separated by single person for detection.Results A total of 323196 samples were tested by NAT from 2015 to 2018.Among the total samples,607 pools(pool of6 samples)were detected as reactive samples,and 389 samples were detected as reactive samples by a single-person split test.The positive rate of single-person split test was 64.09%,and the total positive rate of NAT was 0.12%.The positive rate of disassembly decreased with the increase of cycle threshold(Ct)of reactionary pool,and the difference of positive rate between different Ct values had statistical significance(χ2=140.3,P=0.000).In addition,the difference of total positive rate of NAT between 2015 and 2018 had no statistical significance(χ2=2.149,P=0.542).The total NAT detection rate of non-reactive samples performed by ELISA test(0.11%)was significantly lower than the total NAT detection rate of double-reagent gray area and single-reagent positive(or gray area)samples(9.49%)(χ2=316.00,P=0.000).Conclusion The risk of transfusion transmitted diseases in blood of NAT in Wenzhou is mainly due to HBV.The application of NAT technology can effectively ensure blood safety.
作者
朱紫苗
张炳权
刘燕飞
蔡淑锋
张锋
ZHU Zi-miao;ZHANG Bing-quan;LIU Yan-fei;CAI Shu-feng;ZHANG Feng(不详;Clinical Laboratory,Wenzhou Central Blood Station,Wenzhou,Zhejiang 325000,China)
出处
《中国卫生检验杂志》
CAS
2020年第18期2297-2299,2302,共4页
Chinese Journal of Health Laboratory Technology
关键词
核酸检测
血液筛查
输血风险
血液安全
Nucleic acid detection
Blood screening
Transfusion risk
Blood safety
