开展病毒核酸扩增检测前后的献浆员传播丙型肝炎病毒残余风险对比  

Comparison of HCV blood transmissible residual risk for plasma collection population before and after performing virus nucleic acid amplification test

作　　者：王婧 段艳 周梦云 佘昭 汪岩 李贻娟 何学新 曾飞翔 林涛 Wang Jing;Duan Yan;Zhou Mengyun;She Zhao;Wang Yan;Li Yijuan;He Xuexin;Zeng Feixiang;Lin Tao(Department of Plasma Test,Chengdu Rongsheng Pharmaceuticals Co.,Ltd.,Chengdu 610041,China)

机构地区：[1]成都蓉生药业有限责任公司血浆检测部,成都610041

出　　处：《国际生物制品学杂志》2023年第6期365-367,共3页International Journal of Biologicals

摘　　要：目的评估全面开展病毒核酸扩增检测(nucleic acid amplification test, NAT)以来, 采浆区域的献血浆人群经血传播HCV的残余风险。方法分别用ELISA和NAT对21个单采血浆公司在2019.04.15-2020.04.14采集的1 487 050份血浆标本进行抗HCV抗体及HCV RNA筛查, 对筛查出的抗HCV抗体阳性标本采用免疫印记法确证。采用发病率-窗口期模型计算献血浆者传播HCV残余风险。结果重复献血浆人群的HCV感染率为0.004%, 重复献血浆人群传播HCV的残余风险为7.938×10-2/10万份血浆标本, 即1∶1 259 830。结论重复献血浆人群传播HCV残余风险在较低、可控的水平。全面开展NAT后, 与仅进行ELISA筛查相比, 重复献血浆人群的HCV经血传播疾病残余风险有大幅降低。Objective To evaluate HCV blood transmissible residual risk for plasma collection population after carrying out nucleic acid amplification test(NAT).Methods ELISA and NAT were performed to screen anti-HCV and HCV RNA,respectively,on 1487050 plasma samples collected from 21 plasma collection stations from 2019.04.15 to 2020.04.14.Samples positive for anti-HCV were confirmed by Western Blot.Incidence-window period model was used to calculate transmitting HCV residual risk for the donor population.Results The prevalence of repeat donor population was 0.004%.The HCV blood transmissible residual risk for repeat donor population was 7.938×10-2/100000 plasma samples,i.e.1:1259830.Conclusions HCV blood transmissible residual risk for repeat donor populations is at a relatively low and controllable level.After carrying out NAT,compared to ELISA test only,HCV blood transmissible residual risk is greatly reduced.

关 键 词：核酸扩增检测 残余风险 丙型肝炎病毒 重复献血浆人群 

分 类 号：R446.5[医药卫生—诊断学] R457.1[医药卫生—临床医学]