摘要
目的:了解无偿献血人群乙型肝炎病毒(hepatitis B virus,HBV)感染情况,评估TMA技术应用于献血者HBV-DNA筛查的效果及其必要性。方法:采用平行检测ELISA/NAT模式,对2016年3月-2018年2月169160人(次)献血者及部分归队献血者进行常规血清学和NAT检测,对NAT筛查阳性标本行核酸鉴别试验;对单边试剂HBsAg+、HBV-DNA-献血者进行中和确证试验。结果:169160人(次)献血者中,双边试剂HBsAg检测阳性的为803例,占0.476%,单边试剂检测阳性的为243例,占0.144%。对40名HBV-DNA-、单边试剂检测HBsAg+标本经中和确证试验确证,仅有4名为阳性,确证阳性率为10%。检出1003例HBV-DNA+标本,HBsAg和HBV-DNA均为阳性的739例,2者一致率为73.7%。3种试剂阳性检出率比较有统计学差异(P<0.05);Murex试剂和新创试剂2种试剂检出阳性率有统计学差异(P<0.125)。2016年3月-2017年2月和2017年3月-2018年2月期间HBsAg-/HBV-DNA+检出率比较,没有统计学差异(P>0.05)。60名HBsAg-/HBV-DNA+归队献血者中有1名发生HBsAg阳转,该名献血者为HBV窗口期感染;其余59名献血者HBsAg阴性;HBVDNA检测显示,28名献血者HBV-DNA-,31名献血者HBV-DNA+,1名结果为不确定。结论:结合HBsAg检测,常规应用TMA技术检测HBV-DNA能缩短HBV感染的检测窗口期,检出HBV隐匿性感染,避免HBV漏检,从而有效地降低输血后传播乙型肝炎潜在风险。
Objective:To understand the infection of hepatitis B virus(HBV)in blood donors,and to evaluate the effectiveness and necessity of TMA technology for HBV-DNA screening in blood donors.Methods:Using the ELISA/NAT model,routine serology test and NAT were performed in the 169160 donors,including voluntary blood donors and some of donors returned to donor team.For some donors with test positive NAT,nucleic acid identification test was performed.And the HBsAg neutralized and confirmed assay would conduct in blood donors with unilateral HBsAg positive and HBV-DNA negative result.Results:Among 169160 donation cases-times,the donors of bilateral positive of HB sAg detection was 803,accounted for 0.476%;donors of unilateral positive was 243,accounted for 0.144%.For 40 specimens with HBV-DNA negative,unilateral HBsAg positive,the neutralization and confirmed assay was performed.In result,only 4 specimens were confirmed to be HBsAg positive,the confirmed positive rate was 10%.Among detected1003 specimens with HBV-DNA positive specimens,both HBsAg and HBV-DNA positive were 739,the consistency rate between 2 kinds of detection was 73.7%.The comparision of positive rate detected by using 3 kinds of reagents showed that there were statistical differences(P<0.05);moreover,there were statistical difference in positive rate detected by using Murex reagent and In Tec reagent(P<0.0125).The comparison of detected rate of HBsAg+and HBV-DNA+during March 2016-February 2017 showed no statistical difference(P>0.05).Among 60 blood donors with HBsAg"and HBV-DNA+who has retured to the donor team,1 donor presented the transformation of HBsAg from negative to positive,suggesting the HBV infection of window period,HBsAg of the other 59 was negative.The detection of HBV-DNA showed that the HBV-DNA in 28 donors was negative,and the HBV-DNA in 31 donors was positive,1 donor showed HBV-DNA was uncertain.Conclusion:The routine TMA technology combined with ELISA HBsAg can effectively shorten the window period for detection of HBV infection,effectively detect the occult HBV infection,and reduce the potential risk of hepatitis B spread due to blood transfusion.
作者
任本春
周晓真
卓孝福
REN Ben-Chun;ZHOU Xiao-Zhen;ZHUO Xiao-Fu(Fujian Provincial Blood Center,Fuzhou 350004,Province,China)
出处
《中国实验血液学杂志》
CAS
CSCD
北大核心
2019年第6期1998-2002,共5页
Journal of Experimental Hematology
