我国血站输血传播相关传染病标记物检测策略现状研究
Research on the present situation of detection strategies for infectious markers related to transfusion transimission in China
摘要目的:分析我国血站血液检测实验室输血传播传染病的标记物检测策略和基本情况。方法:基于2017—2021年中国大陆血站执业比对工作组数据,收集2017—2021年我国大陆血站执业比对工作组成员单位实验室输血传播传染病的标记物检测策略及基本情况数据,整理后制作图表对检测标记物的选择、检测方法的选择、检测方案等数据进行分析。结果:检测标记物选择一致,但部分单位增加了HTLV检测项目。有47家血站采用2遍酶联免疫吸附试验和1遍核酸的检测方法;3)核酸检测以混样检测为主,其中8混样由2017年17家到2021年降至14家,而6混样由2017年13家到2021年增至22家;罗氏核酸检测系统数量占比最多。结论:为保障血液安全,避免漏检,血站依旧采用2遍酶联免疫吸附试验和1遍核酸为主的检测策略;同时为增加核酸阳性检出率,核酸混样检测为主但是比例逐年降低,单检比例逐年提升。8混样检测逐步向6混样检测策略过渡;实验室核酸检测采用进口核酸系统的占比较大。
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abstractsObjective:To analyze the detection strategy and basic detection situation of markers of infectious diseases transmitted by transfusion in blood testing laboratories of blood stations in China.Methods:Based on the data of practice comparison working party of Blood Stations in Mainland of China from 2017 to 2021, the data on the testing strategies and the basic detection information of the markers for the transmission of infectious diseases through transfusion in the member laboratories of the practice comparison working party of Blood Stations in Mainland of China from 2017 to 2021 were collected, and the situation of the selection for testing markers, testing strategy and the testing method and other relevant aspects were sorted out and analyzed by charts.Results:The selection of the testing markers was consistent, but HTLV testing item was added in some member laboratories. The detection strategy of using two ELISA reagents and one nucleic acid testing (NAT) reagent simultaneously was adopted in 47 member blood stations; 3) NAT method was dominated by mini pool-NAT in member laboratories. The number of members adopting mini-pools of 8 (MP8)-NAT decreased from 17 in 2017 to 14 in 2021, while the number of members adopting mini-pools of 6 (MP6)-NAT increased from 13 in 2017 to 22 in 2021; Roche NAT system accounted for the largest proportion.Conclusions:In order to ensure blood safety and avoid missing detection, the blood stations still adopt the detection strategy of using two ELISA reagents and one nucleic acid testing (NAT) reagent simultaneously; Meanwhile, in order to increase the NAT positive rate, the proportion of mini pool-NAT mainly decreased year by year despite its dominating role, while the proportion of individual donation-NAT increased year by year; NAT method is transiting from mini-pools of 8 (MP8) to mini-pools of 6 (MP6); The proportion of imported NAT system used in NAT laboratory is relatively large.
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