四种血液安全筛查模式对经血传播病毒残余风险的评估

The residual risk of the blood transmitted virus in four detection models

目的评估东莞市10年间采取的4种血液安全筛查模式（2遍酶联免疫法、2遍酶联免疫法和1遍核酸检测、1遍酶联免疫法和1遍核酸检测、2遍酶联免疫和1遍质量升级版核酸检测）后经血传播病毒HBV、HCV、HIV的残余风险。方法收集2008年1月1日—2017年1月12日期间采取的4种血液安全筛查模式后的试验原始数据,采用残余风险数学模型进行风险评估。结果 4种血液安全筛查模式下HBV标志物的反应率在初次献血者均明显高于重复献血者（P〈0.01）,除2遍酶联免疫法检测模式外,其余3种血液筛查模式下初次献血者反应率均明显高于重复献血者（P〈0.01）,采取2遍酶联免疫法的检测模式时HBV和HCV的残余风险分别为1/5 429和1/15 599,均高于其他3种筛查模式;HIV残余风险在2遍酶联免疫检测模式时最低（1/546 448）;最新的筛查模式2遍ELISA＋1遍NAT（v2.0）检测模式下HBV、HCV、HIV的残余风险分别为1/7 405、1/346 020和1/473 934。结论 HBV的残余风险较大,是影响血液安全的主要因素,开展核酸检测可以降低残余风险,选择2遍ELISA＋1遍NAT（v2.0）是较好的筛查模式,选择低危献血人群更有利于血液安全。

Objective To evaluate the residual risk of HBV,HCV and HIV in four detection models（ 2 ELISA,2 ELISA＋NAT（ v1. 0）,1 ELISA＋NAT（ v1. 0）,2 ELISA＋NAT（ v2. 0）） in Dongguan City with a time frame of 10 years. Methods The original data of the 4 models was collected from records during Jan 1 st,2008 to Jan 12 th,2017 and the risk assessment was carried out using a residual risk mathematical analysis model. Results The positive rate of HBV infection in the first-time blood donors was significantly higher than that of the experienced donors in all the 4 models（ P0. 01）,except for the two-time enzyme-linked immunosorbent assay（ ELISA）model. The residual risks of HBV and HCV were 1/5 429 and 1/15 599,respectively in the two-time ELISA model,which were higher than those of the other three models. HIV residual risk was the lowest in the two-time ELISA model. The residual risk was further reduced by carrying out Nucleic Acid Testing（ NAT）. The residual risk of the two-time ELISA model with NAT（ v2. 0） detection was approximately 1/546 448,the residual risk of HBV/HCV/HIV in 2 ELISA ＋ NAT（ v2. 0） model were 1/740 5、1/346 020 和 1/473 934,respectively. Conclusion The residual risk of HBV is high and it is the main factor affecting blood safety. NAT can reduce the residual risk. It is recommended to apply the two-time ELISA model with NAT（ v2. 0） for detection. Obtaining lower-risk blood donors is favorable towards blood safety.