上海地区无偿献血者乙肝病毒核酸检测分析

目的了解无偿献血者乙肝病毒核酸筛查(NAT)阳性人群特点,为血液安全策略提供参考。方法无偿献血者血液经Murex和科华HBsAg ELISA试剂检测,结果为阴性的血液使用cobas TaqScreen MPX试剂进行HBV DNA,HCV RNA,HIV RNA 3项联合核酸检测。对于MPX反应性标本,使用COBAS AmpliPrep/TaqMan进行核酸鉴别试验,同时使用罗氏ECL电化学发光检测系统进行乙肝补充血清学试验。结果 2011年11月1日～2012年1月31日3个月共有献血者86 375人(次),其中有63 351人(次)为初次献血者,HBsAg反应性为1.04%,23 024人(次)为重复献血者,HBsAg反应性为0.46%,两者差异有统计学意义(χ2=63.63,P0.05)。84 990份HBsAg、抗-HCV、抗-HIV1/2阴性血液进行MPX核酸检测,共发现52例(0.060%)HBV DNA阳性,均为低拷贝,含量为(20～200)IU/ml间,其中32例(0.051%)来自初次献血者,20例(0.087%)来自重复献血者,两者比例差异无统计学意义(χ2=3.65,P0.05),没有发现HCV RNA与HIV RNA阳性。结论重复献血者HBsAg反应性比率低于初次献血者;HBsAg阴性献血者HBV DNA阳性率为0.060%,重复献血者HBV DNA阳性率与初次献血者比较,两者差异无统计学意义;开展HBV核酸检测能够进一步保障血液安全。

Detection of HBV DNA in non-remunerated blood donors in Shanghai

Objective To explore the HBV NAT yield in the blood donors from Shanghai.Methods All donations were tested by two different HBsAg ELISA tests.Subsequently,blood donations,which were detected with negative results by the ELISA tests,were screened by a multiplexed NAT test for HBV DNA,HCV RNA and HIV-1 & 2 RNA.Groups of 6 donations were pooled and tested using the cobas Taqscreen MPX test.Reactive pools were resolved by individual-donation tests on the same NAT test.The final reactive samples after resolution testing were confirmed and quantified using the COBAS AmpliPrep/COBAS TaqMan viral load tests,and further supplemental Hepatitis B serological tests were performed using the Roche Elecsys assays that employ the electrochemiluminescence technology.Results A total of 86 375 donations were collected from 1st Nov.2011 to 31st Jan.2012,among which 63 351 were first-time donors,with a HBsAg positive rate of 1.04%;and 23 024 were repeated donors,with a HBsAg positive rate of 0.46%.The remaining 84 990 HBsAg negative donations were screened and revealed that 52(0.060%)donations were HBV DNA reactive with a viral load range from 20 IU/ml to 200 IU/ml.Among 52 HBV NAT reactive donations,32(0.051%)were from first-time donors and 20(0.087%)were from repeated donors.Conclusion The HBV NAT yield in this blood donor population was 1:1693.No statistical differences were observed between first-time donors and repeated donors with HBV DNA.HBV DNA screening should be applied to further ensure blood transfusion safety.