病毒核酸检测对降低输血传播疾病残余风险的分析研究

目的：探讨核酸扩增技术（NAT）对降低输血传播疾病残余风险的可行性。方法（1）采用2种不同厂家的酶联免疫吸附试验（ELISA）试剂同时对无偿献血者血液乙肝病毒表面抗原（HBsAg）、丙肝抗体（抗-HCV）、艾滋病抗体（抗-HIV）进行检测；（2）采用血筛系统检测单人份 HBV DNA、HCV RNA、HIV RNA；（3）对 ELISA 检测阴性、NAT 检测阳性的标本定期进行追踪分析，观察有无血清学转换，以确定感染状态。结果共筛查2011年3月-10月乌鲁木齐地区无偿献血者14696例，其中 ELISA 检测阳性共152例（其中2份标本 HBsAg、抗-HCV 同时阳性）：HBsAg 阳性率为0．52％（76/14696），抗-HCV 阳性率为0．37％（55/14696），抗-HIV 阳性率为0．16％（23/14696）；NAT 检测阳性共71例：HBV DNA 阳性率为0．22％（32/14696），HCV RNA 阳性率为0．17％（25/14696），HIV RNA 阳性率为0．10％（14/14696）；14544例 ELISA 阴性标本经 NAT 检测没有检出 HCV RNA、HIV RNA 阳性标本，检出2例 HBV DNA 阳性标本，经过追踪分析，第1例发生了血清学转换，为“窗口期”感染，第2例无血清学转换，但乙肝核心抗体持续阳性，为隐匿性乙型肝炎。结论ELISA 检测后血液安全性有了很好的保障，但是依然存在输血传播疾病残余风险，NAT 检测可降低输血残余风险，提高输血安全。

Study on reduction of the residual risk of transfusion-transmitted diseases by NAT detection in volunteer donors

Objective To explore the feasibility of NAT in reducing the residual risk of transfusion-trans-mitted diseases.Methods （1）Two ELISA reagents from different kit manufacturers are used to detect HBsAg,anti-HCV,anti-HIV in blood of unpaid blood donors;（2）NAT blood screening system is em-ployed to detect HBV DNA,HCV RNA,HIV RNA of blood of every unpaid blood donors;（3）Subjects whose ELISA assay was negative,the NAT detection was positive were tracked in a regular basis to ob-serve seroconversion so as to determine whether they were infected.Results 14 696 cases of voluntary blood donors were screened in Urumqi from March to October 2011,of which a total of 152 cases were positive by ELISA （Two specimens HBsAg,anti-HCV positive while）：HBsAg positive rate was 0.52%（76/14696）,anti-HCV positive rate was 0.36% （53/14 696 ）,anti-HIV positive rate was 0.16% （23/14 696）;a total of 71 cases were positive in the NAT detection：HBV DNA positive rate was 0.22% （32/14 696）,＆amp;nbsp;HCV RNA-positive rate was 0.17% （25/14 696）,the HIV RNA-positive rate was 0.10% （14/14 696）;14,544 cases of ELISA-negative specimens detected by NAT detection of HCV RNA,HIV RNA-positive specimen were not positive,Two cases were HBV DNA positive,after tracking analysis,one was con-firmed seroconversion in “window period”infection,seroconversion did not occur in the other,but hepati-tis B core antibody was persistently positive,and was confirmed as occult hepatitis B.Conclusion ELISA detection provides a good safety guarantee for blood safety,but there still remains residual risk of transfu-sion-transmitted diseases.NAT detection can reduce blood transfusion residual risk and improve the safety of blood transfusion.