摘要
目的 回顾性分析2016-2021年山东省济南市无偿献血人群血液标本的人类免疫缺陷病毒(HIV)检测结果和追踪数据,为优化HIV血液筛查策略提供数据支持。方法 收集2016-2021年山东省济南市653 135例无偿献血者血液标本,山东省血液中心对所有标本分别进行2遍酶联免疫吸附试验(ELISA)和1遍核酸检测(NAT)试验,所有实验严格按照实验说明书进行阴性或者反应性结果判断,实验结果按照一检ELISA加NAT、二检ELISA加NAT和两遍ELISA加NAT三种检测策略进行统计分析。反应性标本送济南市疾病预防控制中心(CDC)进行免疫印迹(WB)确证试验。结果 653 135例无偿献血者血液标本送检济南市CDC初筛反应性样本642例,经确证追踪共77例为HIV反应性标本,三种检测策略均能将所有反应性标本检出;不同ELISA试剂之间酶免确证反应性符合率比较,珠海丽珠的酶免确证反应符合率最高(39.78%),高于其他试剂,其差异有统计学意义(P<0.05);WB确证阳性的标本,其初筛结果均为双ELISA试剂反应性;同时,WB确证阳性标本的S/CO值普遍偏高,无S/CO值<5者;核酸反应性标本6例,经追踪随访3例为反应性;确证试验结果不确定21例,经追踪随访1例为反应性。结论 选用1遍ELISA联合NAT检测模式可检测出既往所有WB确证反应性者,1遍ELISA联合NAT检测模式可以满足既往六年无偿献血者HIV血液检测安全性的要求。
Objective To analyze the human immunodeficiency virus(HIV)test results and trace data from the voluntary blood donors in Jinan city over the past 6 years retrospectively,so as to provide basis for optimizing HIV blood screening strategies.Methods HIV testing data were collected from 2016 to 2021 from all blood donors in Jinan city,including 2 enzyme-linked immunosorbent assays(ELISA)and 1 nucleic acid test(NAT)test for all specimens at the Blood Center of Shandong Province.All experiments were judged according to the test instructions strictly,and the statistical analyse of all test results were made through 3 test strategies:ELISA reagent A combined with NAT detection mode,ELISA reagent B combined with NAT detection mode,and ELISA dual reagents combined with NAT detection mode.Reactive specimens were sent to the Jinan Center for Disease Control(CDC)for western blotting(WB)confirmatory test,and those with inconclusive confirmatory test results and nucleic acid reactivity were followed up.Results A total of 653135 voluntary blood donors including 642 reactive specimens were sent to Jinan CDC for WB tests,and 77 of which were confirmed as positive specimens.All positive specimens can be detected by 3 test strategies;There was statistically significant difference in confirmed reactive coincidence rate among different reagents(P0.05),and Lizhu reagent had the highest reactive coincidence rate of 39.78%.ELISA dual reagents reactive specimens had high coincidence with WB confirmatory positives.The higher S/CO values of ELISA dual reagents reactive specimens,and there was not less than 5 in all specimens′S/CO.Nucleic acid reactive specimens were found in 6 cases,3 cases were positive after follow-up,21 cases had indeterminate confirmatory test results,and 1 case was positive after follow-up.Conclusion All previously WB confirmed positive can be detected by ELISA single reagent combined with NAT detection mode.The mode of ELISA single reagent combined with NAT detection can meet the safety requirements of HIV blood tes
作者
王凤田
陈剑锋
肖晨
马子荔
陈萍
颜鑫
WANG Feng-tian;CHEN Jian-feng;XIAO Chen;MA Zi-li;CHEN Ping;YAN Xin(Clinical Laboratory,Blood Center of Shandong Province,Jinan,Shandong 250014,China)
出处
《预防医学论坛》
2023年第3期167-171,共5页
Preventive Medicine Tribune
基金
山东省人文社会科学课题(2021-ZXJK-24)
山东省医药卫生科技发展计划(2019WS541)。
