2种血液安全筛查模式及献血次数对无偿献血者血液人类免疫缺陷病毒残余风险的评估

The residual risk of human immunodeficiency virus transmission in two detection models and donors with different donation times

目的评估无偿献血者经血液筛查后输血传播人类免疫缺陷病毒(human immunodeficiency virus,HIV)的残余风险,分析其与血液筛查模式及献血次数的关系,为提高输血安全性提供科学依据。方法使用酶联免疫吸附实验(ELISA)、核酸检测(NAT),对青岛地区2014至2019年的无偿献血者血液标本进行HIV抗原/抗体和HIV RNA检测,反应性标本由疾控中心进行免疫印迹实验(WB)确证,使用数学模型计算输血传播HIV的残余风险。结果1遍ELISA和1遍核酸检测HIV的流行率为0.022%,残余风险为1/463404;2遍ELISA和1遍核酸检测HIV的流行率为0.016%,残余风险为1/388568。重复献血者的HIV流行率为0.013%,残余风险为1/560161;初次献血者的HIV流行率为0.026%,残余风险为1/446114。结论通过对不同血液筛查模式的残余风险分析,有助于实验室筛选出适合该地区的血液安全筛查模式。同时为招募固定、低危的无偿献血者提供依据,保障血液安全。

Objective To assess the residual risk of(human immunodeficiency virus,HIV)in blood after tests in donors,to analyze the relationship of the residual risk with the detection strategies and donation times,and to provide scientific basis for improving the safety of blood transfusion.Methods The preliminary screening test for HIV Ag/Ab and HIV RNA were conducted by enzyme-linked immunosorbent assay(ELISA)and Nucleic Acid Testing(NAT)on the blood samples of volunteer blood donors from 2014 to 2019,the reactivity samples were confirmed by western blot(WB)conducted by CDC.The residual risk of transmitting HIV by blood transfusion of HIV was evaluated by a mathematical model.Results The prevalence rate of HIV by 1-time ELISA with NAT model was 0.022%with the residual risk of 1/463404.The prevalence rate of HIV by 2-time ELISA with NAT model was 0.016%with the residual risk of 1/388568.The prevalence rate of HIV in repeated donors was 0.013%with the residual risk of 1/560161.The prevalence rate of HIV in primary donors was 0.026%with the residual risk of 1/446114.Conclusion Through the residual risk analysis of different blood detection strategies,it is helpful for the laboratory to choose the suitable detection strategy and provide evidence for the recruitment of regular and low risk donors to ensure the blood safety.