CAJ | 학술논문

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。
목적：탐토핵산확증기술（NAT）대강저수혈전파질병잔여풍험적가행성。방법（1）채용2충불동엄가적매련면역흡부시험（ELISA）시제동시대무상헌혈자혈액을간병독표면항원（HBsAg）、병간항체（항-HCV）、애자병항체（항-HIV）진행검측；（2）채용혈사계통검측단인빈 HBV DNA、HCV RNA、HIV RNA；（3）대 ELISA 검측음성、NAT 검측양성적표본정기진행추종분석，관찰유무혈청학전환，이학정감염상태。결과공사사2011년3월-10월오로목제지구무상헌혈자14696례，기중 ELISA 검측양성공152례（기중2빈표본 HBsAg、항-HCV 동시양성）：HBsAg 양성솔위0．52％（76/14696），항-HCV 양성솔위0．37％（55/14696），항-HIV 양성솔위0．16％（23/14696）；NAT 검측양성공71례：HBV DNA 양성솔위0．22％（32/14696），HCV RNA 양성솔위0．17％（25/14696），HIV RNA 양성솔위0．10％（14/14696）；14544례 ELISA 음성표본경 NAT 검측몰유검출 HCV RNA、HIV RNA 양성표본，검출2례 HBV DNA 양성표본，경과추종분석，제1례발생료혈청학전환，위“창구기”감염，제2례무혈청학전환，단을간핵심항체지속양성，위은닉성을형간염。결론ELISA 검측후혈액안전성유료흔호적보장，단시의연존재수혈전파질병잔여풍험，NAT 검측가강저수혈잔여풍험，제고수혈안전。
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), 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.