【摘要】 目的 立足于血液筛查基础数据,探求安全、易行的HIV筛查反应性献血者的评估策略,实现HIV筛查反应性献血者管理的有据可依、安全高效。方法 系统分析2014—2024年间本中心HIV筛查反应性献血者筛查、补充检测、随访以及CDC确证数据,对HIV筛查反应性献血者进行感染确认和感染状态识别。结果 11年间共检出HIV筛查反应性标本1 235份(0.13%,1 235/928 000)。确认HIV无症状期感染(HIV Ag/Ab++&HIV RNA+)199人(16.11%)、HIV早期感染者(HIV Ag/Ab+-&HIV RNA+)2人(0.16%);HIV血清学窗口期感染者(单独HIV RNA+)7人(0.57%)。在HIV RNA未检出的情况下,HIV Ag/Ab+-者可排除HIV感染,而HIV Ag/Ab++者6人中有1人确认感染HIV。在随访前后HIV Ag/Ab检测试剂未变更的情况下,1种试剂单阳者首次随访阴性其后续随访继续保持阴性的比例显著高于首次随访单阳后续转阴的比例(P<0.05),而另1试剂未观察到明显差异(P>0.05)。当随访试剂发生变更时,单阳者首次随访转阴率达96.7%,显著高于随访前后试剂未变更的首次随访转阴率(P<0.05)。结论 结合HIV血液筛查的血清学和核酸检测结果能够准确、高效地确认HIV感染、识别感染状态。在核酸未检出的情况下,HIV Ag/Ab+-都是假阳性,可保留献血资格,但建议复查合格后方可献血,变更复查试剂有利于提高复查合格率;HIV Ag/Ab++存在真阳性风险,可直接屏蔽献血者。更多还原

【Abstract】 Objective To establish evidence-based,safe and efficient management of HIV-reactive blood donors by investigating safe and feasible assessment strategies for HIV-reactive blood donors based on routine blood screening data.Methods The data of blood screening,supplementary testing,follow-up and CDC confirmation for HIV-reactive blood donors in our center from 2014 to 2024 were analyzed systematically to confirm HIV infection and identify infection status.Results There were 1 235 samples(0.13%,1 235/928 000) reactive in HIV blood screening over the 11-year period.Among them,199 donors(16.11%) in asymptomatic HIV infection(HIV Ag/Ab++&HIV RNA+),2(0.16%) as acute early HIV infection(HIV Ag/Ab+-&HIV RNA+) and 7(0.57%) as window-period infection(HIV RNA positive only) were confirmed.Donors with the result of HIV Ag/Ab+-&HIV RNA-(single-positive) were all excluded for HIV infection,while 1 in 6 HIV Ag/Ab++&HIV RNA-donors(double-positive) was confirmed to have HIV infection.When HIV Ag/Ab reagents were used continuously before and after the follow-up,it s observed in one reagent that the proportion of negative results in subsequent follow-up in single-positive donors who had negative results in the first sampling was significantly higher than the proportion of negative results in subsequent follow-up in those initially single-positive(P<0.05).But no significant difference was observed in another reagent(P>0.05).When reagents were changed in follow-up,the rate of singlepositive donors with negative results in the first sampling reached 96.7%,which was significantly higher than the negative rate of those without reagent changing in follow-up(P<0.05).Conclusion Based on the serological and nucleic acid testing results of HIV blood screening,the confirmation of HIV infection and identification of infection status can be achieved accurately and efficiently.All HIV Ag/Ab+-&HIV RNA-donors were confirmed as false positive,and should be maintained their eligibilities for blood donation,but recommended to pass the retest before next donation.Using a different reagent for retesting helps improve the eligible rate.HIV Ag/Ab++&HIV RNA-donors should be deferred permanently due to the risk of true positivity.更多还原