运用单样本核酸扩增检测技术对提高深圳地区HIV检出率的效果分析  

Effect analysis of improving the HIV positive detection rate by single sample nucleic acid amplification test in Shenzhen

作　　者：王宋兴[1] 熊文[1] 古醒辉[1] 刘衡[1] 徐筠娉[1] 曾劲峰[1] WANG Songxing;XIONG Wen;GU Xinghui;LIU Heng;XU Yunping;ZENG Jinfeng(Shenzhen Blood Center,Shenzhen,Guangdong 518035,China)

机构地区：[1]深圳市血液中心,广东深圳518035

出　　处：《国际检验医学杂志》2018年第13期1562-1565,共4页International Journal of Laboratory Medicine

基　　金：广东省医学科研基金资助(A2016222);深圳市战略新兴产业发展专项资金资助(JSGG20160328103642937)

摘　　要：目的分析运用单样本核酸扩增检测技术(SS-NAT)对提高深圳地区HIV检出能力的效果,探讨SS-NAT对降低输血感染HIV残余风险的作用。方法采用Procleix Tigris单样本核酸检测系统和第三代、第四代两种酶联免疫吸附试验(ELISA)试剂对2015年1月至2017年8月采集的269 228份无偿献血者血液标本进行平行检测。对ELISA检测无反应性而SS-NAT有反应性的标本进行HIV鉴别试验,并对鉴别有反应性的献血者进行追踪检测。所有ELISA或SS-NAT HIV鉴别试验有反应性的样本均送到深圳市疾病预防控制中心(CDC)做免疫印迹法(WB)确证试验。结果 269 228份样本HIV第三代ELISA试剂检测有反应性188份,有反应性率为0.698‰(188/269 228),第四代ELISA试剂检测有反应性340份,有反应性率为1.263‰(340/269 228),两种ELISA试剂共检测有反应性422份,有反应性率为1.567‰(422/269 228),SS-NAT检测有反应性共103份,有反应性率为0.383‰(103/269 228),其中有4份ELISA无反应性而SS-NAT有反应性标本,对应献血者随访追踪血液标本ELISA和SS-NAT均呈有反应性。所有ELISA或SS-NAT HIV鉴别试验有反应性标本经CDC确认有103份标本呈阳性。ELISA检测后HIV窗口期检出率为1∶67 307(4/269 228)。结论 SS-NAT应用于血液筛查可提高HIV检出率,缩短HIV检测窗口期,降低输血感染HIV残余风险,从而有效提高输血安全性。Objective To investigate the effect of improving the human immunodeficiency virus（HIV）positive detection rate by single sample nucleic acid amplification test（SS-NAT）in Shenzhen,and to explore the effect of SS-NAT on reducing the risk of HIV infection in transfusion.Methods 269 228 blood samples were performed parallel detection by SS-NAT（Procleix Tigris）and two kinds of enzyme-linked immuno sorbent assay（ELISA）reagents,and then the samples with nonreactive by ELISA and reactive by SS-NAT were tested by HIV identification assay.The blood donors with reactive HIV identification assay were made tracing tests.All the samples with reactive by ELISA or HIV identification assay were sent to the Shenzhen Center for Disease Control and Prevention（CDC）for Western Blot（WB）diagnostic tests.Results The samples with reactive by the third generation ELISA reagents,the fourth generation ELISA reagents,both ELISA reagents and SS-NAT were 188,340,422 and 103,which reactive rate was 0.698‰（188/269 228）,1.263‰（340/269 228）,1.567‰（422/269 228）and 0.383‰（103/269 228）,respectively.We found four samples with nonreactive by ELISA but reactive by SS-NAT.The four donors were found HIV reactive by both ELISA and SS-NAT after tracing.All the samples with reactive by ELISA or HIV identification assay were sent to CDC for confirmatory tests and 103 of them were positive.The positive detection rate of transfusion-transmissible HIV infection after ELISA detection was 1∶67 307（4/269 228）.Conclusion The application of SS-NAT in blood screening can improve the HIV positive detection rate,shorten window period of HIV detection and reduce residual risk of transfusion-transmissible HIV infection,and then blood safety can be effectively improved.

关 键 词：核酸检测 酶联免疫吸附试验 人类免疫缺陷病毒 窗口期 输血安全 

分 类 号：R512.91[医药卫生—内科学]