核酸检测反应性献血者归队方法学及可行性的初步研究

The Primary Study on the Methods and Feasibility of Re-entry of NAT Reactive Blood Donors

目的实验探讨NAT反应性献血者归队的方法和可行性。方法挑选2012年-2014年ELISA无反应性NAT反应性献血者,获其知情同意后召回收集血样。先进行常规ELISA(HBs Ag、抗-HCV、抗-HIV和抗-TP)和NAT(HBV-DNA、HCV-RNA和HIV-RNA)检测。若均为无反应性的,再继续进行高灵敏度的化学发光法补充试验(HBs Ag、HBe Ag、抗-HBs、抗-HBc、抗-HBe、抗-HCV、抗-HIV)。结果召回献血者30人,经检测仍为ELISA无反应性NAT反应性的11例,拟建议永久屏蔽;ELISA、NAT均为无反应性的19例,化学发光法检测89.5%为抗-HBc和/或抗-HBe反应性(12例抗-HBc、抗-HBe均反应性,5例抗-HBe反应性)。抗-HBc或抗-HBe反应性存在感染风险,拟建议永久屏蔽。2例所有项目均无反应性,拟建议可以考虑归队。结论 NAT反应性献血者归队有其必要性和现实意义,但为血液安全考虑,应建立1个谨慎的适合中国人群的NAT反应性献血者归队方案。

Objective To study the methods andfeasibility of re-entry of NAT reactive blood donors.Methods ELISA Non-Reactive（NR） and NAT Reactive（R） Blood Donors in 2012-2014 were selected and informed consent. Blood samples collected were tested： ELISA（ HBsAg,Anti-HCV,Anti-HIV and Anti-TP） and NAT（ HBV-DNA, HCV-RNA and HIV- RNA）. ELISA NR/NAT NR samples were tested by ECLA for HBsAg,HBeAg,Anti-HBs,Anti-HBe,Anti-HBe,Anti-HCV, Anti-HIV. Results 30 donors were called back, and 11 of them were ELISA NR/NAT R, which were deferred permanently. 19 of them were ELISA NR/NAT NR, and the ECLA results were 89.5% ELISA NIL/NAT NR donors were Anti-HBe R and/or Anti-HBe R （ 12 cases Anti-HBc/Anti-HBe R,5 cases Anti-HBe R）. Anti-HBc R or Anti-HBe R donors had risk of infection, which were deferred permanently. 2 eases all items Non-Reactive may be eligible for re-entry. Conclusion Re-entry of NAT reactive blood donors is very necessary and meaningful, but in the view of blood safety, it is important that establish a set of safe program for Chinese.