摘要
目的了解核酸检测技术在福州地区无偿献血者血液筛查中的应用情况,评估开展血液核酸检测的必要性和试剂升级前后的检测性能差异。方法应用Procleix TIGRIS全自动核酸检测系统,对无偿献血者血液标本进行HBV/HCV/HIV-1联合检测,同时采用2种血清学ELISA试剂对所有标本进行HBsAg、抗-HCV、抗-HIV/P24和抗-TP等项目并行检测,并对核酸联合筛查反应性的标本进行鉴别试验。结果 2012年～2017年,共检测献血者血液标本491159份,其中ELISA无反应性,NAT反应性标本共计1637份,检出HBV窗口期标本共477份,HIV窗口期标本2份。2015年核酸检测升级后,ELISA无反应性NAT反应性率由0.28%提高到0.41%,鉴别阳性的预测值由25.61%提高到33.89%。结论核酸检测技术应用于无偿献血者血液筛查能有效降低输血感染风险,保证临床用血安全,试剂的更新升级有助于检测性能提高。
Objective To analyze NAT used in the blood donation screening in Fuzhou areas,evaluate the necessity of NAT for blood donation testing and the difference of proficiency after reagent updating. Methods All of the specimens were tested by Procleix TIGRIS NAT System for HBV/HCV/HIV-1, and HBsAg, anti-HCV, anti-HIV/P24, anti-TP tested by two different companies' ELISA kits. Furthermore, the NAT reactive specimens were further confirmed by discriminatory NAT.Results 491 159 blood donors' specimens were tested from 2012 to 2017, the ELISA negative and NAT reactive specimens were 1 637, after discriminatory NAT 477 were HBV positive and 2 were HIV positive. Updating of the reagent since 2015,NAT reactive rates were improved from 0.28% to 0.41%, and the rates of discriminatory improved from 25.61% to 33.89%.Conclusion The window period of blood transfusion infection could be shorten and the blood safety improved after NAT used for blood screening. The sensitivity of the NAT reagent was improved after updating.
引文
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