单采血小板献血者初复检检测模式的分析  

Initial screening and retest mode in apheresis platelet donors:a comparative analysis

作　　者：陈元锋[1] 吴晓玲[1] 赵爱平[1] CHEN Yuanfeng;WU Xiaoling;ZHAO Aiping(Blood Center of Shandong Province,Jinan 250014,China)

机构地区：[1]山东省血液中心,山东济南250014

出　　处：《中国输血杂志》2023年第3期208-211,共4页Chinese Journal of Blood Transfusion

基　　金：山东省卫生健康政策研究重点课题(WZY202259)。

摘　　要：目的统计现行单采血小板献血者献血前初复检指标的筛查效果及评价该检测策略的适当性。方法收集本中心2019年1月~2021年12月(3年)的18510人单采献血者初筛(速率法ALT、金标法HBsAg)及复检(速率法ALT、ELISAHBsAg)结果数据,按照各年度、不同献血次数做回顾性分析比较及统计学处理。结果捐献单采血小板献血者血液筛查:1)2019至2021年初筛(ALT+HBsAg)不合格率为12.98%(2403/18510),其中ALT不合格率依次为13.19%(712/5398)、13.33%(873/6549)和11.05%(725/6563),2021年与其余两年相比均存在明显差异(P<0.05);HBsAg不合格率依次为0.43%(23/5398)、0.66%(43/6549)和0.41%(27/6563),2021年与2019年相比存在明显差异(P<0.05),与2020年相比无明显差异(P>0.05);2)2019至2021年复检(ALT+HBsAg)不合格率为0.26%(40/15412),其中ALT不合格率分别为0.20%(9/4410)、0.06%(3/5387)和0.07%(4/5615),HBsAg不合格率分别为0.18%(8/4410)、0.20%(11/5387)和0.09%(5/5615)(均为P>0.05);3)复检ALT不合格中68.75%(11/16)为初筛ALT≥45 U/L,复检ELISA HBsAg不合格中91.67%(22/24)是单试剂阳性。结论单采血小板献血者初筛ALT临界值设定为<45 U/L可以有效降低复检不合格率,仅对初次献血者做HBsAg筛查可降低检测成本。根据当地经血液传染病流行情况,献血前可增加相应指标的检测,将有助于进一步减少单采血小板的报废率。Objective To investigate the effectiveness of current indicators in initial screening and retest before donation and access the optimal testing strategies.Methods Data of initial screening(rate method for ALT,colloidal gold method for HBsAg)and retest(rate method for ALT,ELISA for HBsAg)of 18510 platelet donors in our center from January 2019 to December 2021 were collected,and the results were retrospectively analyzed and compared in terms of different years and number of donations.Results From 2019 to 2021,data of initial screening and retest of platelet donors were as follows:1)the deferral rate of ALT and HBsAg was 12.98%(2403/18510)vs 0.26%(40/15412);2)the deferral rate of ALT was 13.19%(712/5398)us 0.20%(9/4410)in 2019,13.33%(873/6549)us 0.06%(3/5387)in 2020 and 11.05%(725/6563)us 0.07%(4/5615)in 2021;for initial screening,significant difference was noticed in ALT reactivity in 2021 as in comparison to other two years(P<0.05);3)the reactive rate of HBsAg was 0.43%(23/5398)us 0.18%(8/4410)in 2019,0.66%(43/6549)us 0.20%(11/5387)in 2020 and 0.41%(27/6563)us 0.09%(5/5,615)in 2021.For initial screening,HBsAg deferral in 2021 was significantly different from 2019,while similar with 2020.4)Among ALT deferral samples in the retest,68.75%(11/16)were ALT≥45 U/L.Among HBsAg reactive samples,91.67%(22/24)were reactive by single reagent.Conclusion Setting the threshold value of ALT for platelet donors in initial screening as less than 45 U/L can effectively reduce the reactive rate in the retest.HBsAg screening only for first-time platelet donors can reduce the detection cost.Adding pre-donation detection indicators according to local prevalence of transfusion transmitted diseases is conductive to reduce the discarding rate of platelets.

关 键 词：单采血小板献血者 血液筛查模式 检测策略 ALT/HBsAg初筛阳性率 复检阳性率 ELISA NAT 

分 类 号：R446.6[医药卫生—诊断学]