芜湖地区无偿献血者HIV筛查策略及确认结果分析

目的分析芜湖地区无偿献血者中HIV感染情况,为完善献血招募策略和临床安全用血提供有效数据。方法选取2017年1月~2020年9月芜湖地区全部无偿献血者中HIV筛查反应性标本,送检至市疾控中心进行确认试验。利用受试者工作特征曲线(ROC曲线)比较酶免试剂的准确性;通过ELISA检测最适临界值分析血清学灰区设置;比较确认阳性、阴性和不确定标本的初筛S/CO值,使用SPSS 22.0软件分析差异显著性。结果送检75例HIV初筛反应性标本:确认阳性17例,17例不确定,41例阴性。4代抗-HIV ELISA试剂的曲线下面积(AUC)大于3代试剂,在准确性上4代试剂更优于3代试剂;17例确认阳性标本均是双试剂反应性高S/CO值,其初筛S/CO值显著高于确认阴性和不确定标本初筛值(P<0.05),确认阴性和不确定结果的S/CO值没有统计学差异(P>0.05)。结论芜湖地区无偿献血者中HIV感染率处于全国中等水平;血清学检测的灰区设置意义不大;应通过规范的献血前干预、灵敏的核酸检测技术和共享区域数据平台等措施进一步保障血液安全。

HIV screening and confirmation results of voluntary blood donors in Wuhu area

Objective To analyze the HIV infection among voluntary blood donors in Wuhu area, so as to provide effective data for improving blood donation recruitment strategies and clinical safe blood use. Methods All reactive samples from HIV screening among voluntary blood donors in Wuhu from January 2017 to September 2020 were selected and sent to Wuhu CDC for confirmation test.The receiver operating characteristic(ROC) curve was used to compare the accuracy of enzyme-immune reagents. The optimal critical value of ELISA was used to analyze the setting of serological gray area. The preliminary screening S/CO values of confirmed positive, negative and indeterminate samples were compared, and the significance of differences were analyzed by SPSS 22.0 software. Results 75 cases of initially HIV reactive samples were submitted for testing: 17 cases were confirmed positive, 17 indeterminate and 41 negative.The area under curve(AUC) of the 4 th generation anti-HIV ELISA reagent was greater than that of the 3 rd generation reagent, and the 4 th generation reagent was better than the 3 rd generation reagent in accuracy. All the 17 confirmed positive samples had high S/CO reactivity with duplicate reagents, and the initial screening S/CO value was significantly higher than that of confirmed negative and indeterminate samples(P<0.05). There was no significant statistical difference in S/CO values between confirmed negative and indeterminate results(P>0.05).Conclusion Voluntary blood donors in Wuhu is a middle-endemic population for HIV infection. The setting of grey areas for serological testing is of little significance. Blood safety should be further guaranteed through standardized pre-donation interventions, sensitive nucleic acid detection technologies and shared regional data platforms.