摘要
目的分析我国17家省级血液中心献血人群的人类免疫缺陷病毒(HIV)筛查情况,及其筛查后的残余风险(RR)。方法采用横断面研究,通过中国采供血机构执业比对信息管理系统,收集2015年1月至2024年12月我国17家血液中心每10万例初次献血人群(FD)和重复献血人群(RD)中检测HIV感染标志物的数据,使用调查表收集各血液中心的HIV血液筛查策略、筛查程序、血清学检测试剂厂家、血清学检测设置灰区情况以及核酸检测模式、方法、系统。使用发病率-窗口期模型计算各血液中心筛查HIV后的初次献血人群残余风险(RRFD)、重复献血人群残余风险(RRRD)和总献血人群残余风险(RRTD)。横向和纵向分析各中心RRFD、RRRD和RRTD变化情况。结果17家血液中心的HIV血液筛查策略均采用2遍血清学检测+1遍核酸检测。采用1种HIV血液筛查程序的血液中心有8家,2种有6家,3种有3家。血清学检测试剂厂家选择中,使用进口和国产检测试剂有11家,仅使用国产试剂有5家,仅使用进口试剂有1家。4家血液中心10年间不设置血清学检测灰区。核酸检测模式选择中,8家血液中心核酸检测单检(ID-NAT)和核酸检测混检(MP-NAT)均有使用,8家仅使用MP-NAT,1家仅使用ID-NAT。核酸检测方法中,同时使用转录介导扩增(TMA)、聚合酶链反应(PCR)的血液中心有7家,仅使用PCR有9家,仅使用TMA有1家。使用进口和国产核酸检测系统的血液中心有14家,2家仅使用进口系统,1家仅使用国产系统。17家血液中心10年平均值RRFD范围为(2.22~12.33)/106py,RRRD范围为(0.83~3.29)/106py,RRTD范围为(1.59~9.29)/106py,Z4中心的RRFD、RRRD、RRTD均为最低值,U4的RRFD、RRTD和D2的RRRD分别为最高值。11家血液中心2024年的RRFD和10家血液中心2024年的RRRD、RRTD低于2015年。W2和U4的RRFD、RRTD波动较大,后期呈上升趋势。结论17家血液中心HIV筛查策略一致,筛查程序、血清学检测试剂厂家以及核酸检测模式、方法、系统的选择均存在差别,且RRFD、RRRD、RRTD均不同,多数中心的RR在10年间有所下降,但也有部分中心的数据波动并呈现上升趋势,提示HIV筛查方案可进一步优化。
ObjectiveTo analyze the human immunodeficiency virus(HIV)screening status and the resulting residual risk(RR)among blood donors across 17 provincial blood centers in China.MethodsThis study used a cross-sectional study.Data on HIV infection markers per 100000 first-time donors(FD)and repeat donors(RD)from January 2015 to December 2024 were extracted from the National Blood Establishment Performance Comparison Information Management System.Questionnaires were used to collect each center′s HIV screening strategy,algorithm,serological test(ST)kit manufacturers,gray-zone setting for ST,and nucleic acid test(NAT)modality,method,and platform.The incidence-window-period model was used to calculate the residual risk for first-time donors(RR FD),repeat donors(RR RD),and total donors(RR TD)at each center.Horizontal and vertical analysis of RR FD,RR RD,and RR TD across centers and years were performed.ResultsAll 17 centers applied the same HIV screening strategy which was two rounds of ST followed by one round of NAT.Eight of them operated a single screening algorithm,six employed two algorithms and three used three.Eleven centers used both imported and domestic ST kits,five relied on domestic ST kits only,and one used imported ST kits only,while four centers never set a grey zone for ST throughout the decade.For NAT modalities,eight centers adopted both individual nucleic acid test(ID-NAT)and minipool nucleic acid test(MP-NAT),eight used MP-NAT only and one used ID-NAT only.Seven centers combined transcription mediated amplification(TMA)and polymerase chain reaction(PCR),nine used PCR only and one used TMA only,and fourteen centers ran both imported and domestic NAT systems,two used imported systems only and one used a domestic system only.Over the ten-year period,the mean RR FD across the centers ranged from 2.22 to 12.33 per 106 person-years,RR RD from 0.83 to 3.29 per 106 person-years and RR TD from 1.59 to 9.29 per 106 person-years,with center Z4 consistently showing the lowest values for all three metrics and center U4 recording the highest RR FD and RR TD,while center D2 had the highest RR RD.In 2024 compared with 2015,eleven centers achieved a lower RR FD and ten centers achieved lower RR RD and RR TD.The RR FD and RR TD of centers W2 and U4 displayed pronounced fluctuations and an upward trend in recent years.ConclusionsThe 17 provincial blood centers maintain consistent HIV screening strategies,while demonstrating variations in screening algorithm,ST kit manufacturers,NAT modalities,methods,and platform.And the RR FD,RR RD,and RR TD differ across centers.Although most centers show declining trend in RR over the ten-year period,some centers exhibite data fluctuations with a rising trend,suggesting potential for further optimization of HIV screening protocols.
作者
吴思其
刘颖
张硕
李玉军
邹彬彬
王林
唐飞
冯惟萍
万艳红
刘妍妍
李莹
肖晨
温涛
巩晗实
付珊
胡文佳
邱艳
Wu Siqi;Liu Ying;Zhang Shuo;Li Yujun;Zou Binbin;Wang Lin;Tang Fei;Feng Weiping;Wan Yanhong;Liu Yanyan;Li Ying;Xiao Chen;Wen Tao;Gong Hanshi;Fu Shan;Hu Wenjia;Qiu Yan(Institute of Blood Transfusion,Chongqing Blood Center,Chongqing 400015,China;Office,Heilongjiang Provincial Blood Center,Harbin 150001,China;Office,Inner Mongolia Autonomous Region Blood Center,Hohhot 010070,China;Laboratory Department,Ningxia Hui Autonomous Region Blood Center,Yinchuan 750011,China;Blood Testing Department,Changsha Blood Center,Changsha 410024,China;Quality Management Department,Hainan Provincial Blood Center,Haikou 570311,China;Business&Information Management Department,Guizhou Provincial Blood Center,Guiyang 550002,China;Laboratory Department,Gansu Red Cross Blood Center,Lanzhou 730046,China;Quality Management Department,Taiyuan Blood Center,Taiyuan 030024,China;Office,Tianjin Blood Center,Tianjin 300110,China;Business Department,Jiangxi Provincial Blood Center,Nanchang 330052,China;Laboratory Department,Shandong Provincial Blood Center,Jinan 250013,China;Business Department,Henan Red Cross Blood Center,Zhengzhou 450014,China;First Business&Technology Department,Shaanxi Provincial Blood Center,Xi′an 710061,China;Laboratory Department,Wuhan Blood Center,Wuhan 430030,China;Laboratory Department,Jiangsu Provincial Blood Center,Nanjing 210042,China;Office,Beijing Red Cross Blood Center,Beijing 100088,China)
出处
《中华传染病杂志》
北大核心
2025年第10期590-598,共9页
Chinese Journal of Infectious Diseases
基金
重庆市输血协会华兰生物科研基金(CQSX-HL-202502)。
