核酸筛查中混检阳性拆分单检阴性血液标本的HBV残余风险分析  

HBV residual risk analysis of MPX-6 Positive but Individual Test negative blood specimens in nucleic acid screening

作　　者：周磊[1] 刘颖[1] 邓雪莲[1] 邹亚轩[1] 周璐[1] 王新梅[1] 臧亮[1] ZHOU Lei;LIU Ying;DENG Xuelian;ZOU Yaxuan;ZHOU Lu;WANG Xinmei;ZANG Liang(Daliang Blood Center,Dalian 116001,China.)

机构地区：[1]大连市血液中心

出　　处：《中国输血杂志》2018年第9期985-988,共4页Chinese Journal of Blood Transfusion

摘　　要：目的了解大连地区无偿献血者血液筛查中混样反应性拆分单检无反应性血液标本的输血传播乙型肝炎病毒（HBV）残余风险,评估应用不同原理核酸检测（NAT）血液筛查系统在降低输血传播HBV残余风险中的作用。方法应用PCR-荧光探针法（Cobas Taq Screen MPX Test,V2. 0）以6人份混样模式做定性检测HBV/HCV/HIV,混检反应性标本行拆分单检,采用TMA检测平台（Ultrio Plus/Ultrio Elite）对拆分无反应性的标本进行单检。TMA NAT平台得到的反应性标本再分别重复联检3遍,同时应用PCR-荧光探针法进行4遍6人份混样检测和4遍单人份检测,并用罗氏电化学发光作为第3方试剂,对标本乙肝血清学5项进行检测,以确认HBV感染情况。结果2017年8月—2018年7月,本中心MP-NAT方法共检测9 689 pool（57 868份无偿献血者标本）,混检呈反应性的有88 pool,经单人份拆分检测,其中拆分实验结果呈无反应性的有24 pool（141份标本）,拆分阳性率为72. 73%。141份标本用TMA联检实验复检,4份标本呈反应性。将4份标本分别重复4遍MPX-6 NAT,结果均为无反应性; 4份标本又进行4遍ID-NAT实验,仅有2份标本呈反应性（S018001 1/4,S018002 3/4）,其余2份标本仍不能重现反应性结果。Tigris和Panther NAT系统对该4份标本分别重复3遍HBV/HCV/HIV联检实验,结果显示,Tigris系统有2份标本呈反应性（S018002 3/3,S018004 1/3）; Panther系统中,也有2份标本检测结果呈反应性（S018001 2/3,S018002 1/3）。仅1份标本不可重现核酸反应性。用电化学发光法检测乙肝两对半,结果可见,4份标本的A-HBc均为阳性; 2份标本A-HBe为阳性（S018002,S018004）; 2份标本HBsAg为阳性（S018001,S018004）。结论核酸筛查中混样阳性拆分单检阴性血液标本有输血HBV感染残余风险,对这部分标本的结果判定需慎重对待,防止漏检,以提高血液的安全性。Objective In order to analyze the residual risk of HBV transfusion-transmitted hepatitis B virus（ HBV） in the blood screening of blood donors in Dalian area,and to evaluate the role of nucleic acid detection（ NAT） blood screening systems in reducing the residual risk of HBV transfusion-transmitted. Methods The QPCR Test（ Cobas Taq Screen MPX Test,V2. 0） was used for qualitative detection of HBV/HCV/HIV in pools of 6,and the reactive pool＇s specimens were tested by ID-NAT. If the results were non-reactive,the specimens were examined using the transcription-mediated amplification（ TMA） technique（ Ultrio Plus/Ultrio Elite）. The replicated reactive specimens were tested 3 times joint test and plus discrimination test by TMA NAT platform,at the same time Roche Cobas s 201 Taq Screen system was applied to 4 times MPX-6 test and 4 times individual test. We applied Roche electrochemical luminescence as third party reagent to confirm HBV infection status. Results From August 2017 to July 2018,a total of 9 689 pools（ 57 868 blood donors） were detected by MPX Test method in the blood center. 88 pools were reactivity in the mixed test,and 24 pools（ 141 specimens） were non-reactive in the split test,with a positive rate of 72. 73%. 141 specimens were re-tested using the Procleix Ultrio Plus/Elite assay,then 4 specimens presented reactivity. But the repeated test showed not all 4 specimens were repeated reactivity. HBsAg positivity was confirmed by using ECL method. As a result,the residual risk of HBV was found in all 4 samples,which could not be used in clinical blood transfusion. Conclusion Blood specimens of MPX-6 positive,but individual test negative in nucleic acid screening have the residual risk of HBV infection in blood transfusion. The determination of the results of these samples should be treated carefully to improve the safety of blood.

关 键 词：核酸检测 血液筛查 乙型肝炎病毒 残余风险 

分 类 号：R446.112[医药卫生—诊断学] R512.62[医药卫生—临床医学]