【摘要】 目的 通过对HIV筛查反应性的献血者进行综合评定,建立起简易、有效且安全地排除假阳性、识别感染的方法,为HIV筛查反应性献血者的管理策略制定提供依据。方法 收集本实验室2022年1月—2024年12月献血者HIV检测情况,将酶联免疫(ELISA)和核酸检测(NAT)结果与CDC的确证结果相结合进行分析。结果 3年间共检测标本605 929份,其中HIV反应性标本682份,不合格率11.25/万,全部送CDC进行WB法确证抗-HIV,确证阳性53份,反应性标本确证阳性率7.77%。其中,HIV Ag&Ab单阳(单试剂反应性)且NAT无反应性(HIV Ag&Ab+-&HIV RNA-或NAT NR)标本619份,确认HIV感染率为0%;HIV Ag&Ab双阳(双试剂反应性)且NAT无反应性(HIV Ag&Ab++&HIV RNA-或NAT NR)标本9份,确认感染率0%;HIV Ag&Ab双阳且NAT反应性(HIV Ag&Ab++&HIV RNA+或NAT R)标本52份,确认感染率100%;NAT未检的HIV Ag&Ab双阳标本2份,确认感染率100%。研究期间使用的4种HIV Ag&Ab试剂均显示双阳真阳性标本的S/CO值分布远高于单阳假阳性和双阳假阳性标本的S/CO值分布(P<0.05),4种试剂单阳假阳性标本和双阳假阳性标本的S/CO值分布范围均较窄且箱体图上沿Q3(75%)都低于最佳屏蔽界值(4种试剂最佳屏蔽界值分别为5.00、11.67、8.50、20.90)。结论 HIV血液筛查NAT R的献血者永久屏蔽,HIV Ag&Ab双阳但NAT NR者根据HIV Ag&Ab的S/CO值与最佳屏蔽界值的高低来分类管理,HIV Ag&Ab单阳但NAT NR者进入评估状态,保留献血资格。优化献血者管理措施,建立科学的分层管理与评估机制,可有效维护献血者队伍稳定性。更多还原

【Abstract】 Objective To explore a simple,effective,and safe method for excluding false positives and identifying infections by comprehensively evaluating blood donors with reactive HIV screening results,thereby providing a basis for developing management strategies for such donors.Methods HIV testing data of blood donors from our laboratory from January2022 to December 2024 were collected.The results of ELISA and nucleic acid testing(NAT) were combined with confirmatory results from the CDC and analyzed.Results A total of 605 929 samples were tested for HIV over the three-year period,with 682 reactive samples(reactive rate:11.25 per 10 000).All were sent to the CDC for Western blot(WB) confirmation,resulting in 53 confirmed positives((confirmed positive rate:7.77%).Among these,619 samples showed isolated HIV Ag&Ab reactivity with non-reactive NAT(HIV Ag&Ab+-& HIV RNA or NAT RR),with a confirmed infection rate of0%;9 samples showed dual HIV Ag&Ab reactivity with non-reactive NAT(HIV Ag&Ab++& HIV RNA NR or NAT NR),also with 0% confirmed infection;52 samples showed dual HIV Ag&Ab reactivity and reactive NAT(HIV Ag&Ab++& HIV RNA R or NAT R),all confirmed as positive(100% infection rate);and 2 HIV Ag&Ab dual-reactive samples without NAT detection were also confirmed infected(100%).For all four HIV Ag&Ab assays,the S/CO values in the true positive group with dual reactivity were significantly higher than those in the false-positive groups(P<0.05).The S/CO distributions for both single-reactive false positives and dual-reactive false positives were narrow,with the upper box(Q3,75th percentile)below optimal cutoff values in all cases(The optimal cutoff values for the four reagents were 5.00,11.67,8.50,and 20.90,respectively).Conclusion Blood donors with positive NAT results in HIV blood screening are permanently deferred.Donors with dual positive HIV Ag&Ab but negative NAT results are classified and managed based on the S/CO values of HIV Ag&Ab and the optimal screening thresholds.Donors with single positive HIV Ag&Ab but negative NAT results are placed under evaluation status and retain their eligibility to donate blood.Optimizing the management measures for blood donors and establishing a scientific stratified management and assessment mechanism can effectively maintain the stability of the blood donor team.更多还原