血液核酸检测试剂UltrioPlus与Ultrio检测结果分析及血液检测模式的探讨  

Analysis of blood screening results by nucleic acid testing using ultrioplus and ultrio assays and in different screening modes

作　　者：杜荣松[1] 王淏[1] 梁浩坚[1] 李仲平[1] 林诗雅[1] 谢君谋[1] 黄志健[1] 蓝岚茵[1] 郑优荣[1] DU Rongsong;WANG ftao;LIANG Haojian;LI Zhongping;LIN Shiya;XIE Junmou;HUANG Zhijian;DIN Lanyin;ZHENG Yourong.(Guangzhou Blood Center, Guangzhou 510095, China.)

机构地区：[1]广州血液中心广州市医学重点实验室

出　　处：《中国输血杂志》2018年第2期137-140,共4页Chinese Journal of Blood Transfusion

基　　金：广州市医药卫生科技项目(20161A011056)

摘　　要：目的分析TIGRIS血液筛查系统采用新旧两代试剂及新一代试剂不同检测模式核酸单反应性变化情况,为进一步提高核酸检测质量提供参考。方法回顾分析2011—2016年血液标本采用Ultrio或UltrioPlus核酸检测（NAT）试剂与酶免疫法（EIA）试剂平行血液检测（NAT/EIA平行检测模式）,以及血液标本先采用EIA试剂检测,后采用UltrioPlus NAT试剂检测EIA合格标本（先EIA后NAT检测模式）,2种模式的核酸联检单反应性率和鉴别反应性率。结果 2011—2015年,采用NAT/EIA平行检测模式,Ultrio试剂检测血液标本1 412 432例,核酸联检单反应性率、核酸鉴别反应性率和HBV DNA检出率分别为：0.23%、29.20%和0.07%,各年份核酸联检单反应性率、核酸鉴别反应性率差异分别为P〈0.05（χ2=9.80）和P〈0.05（χ2=3.91）;Ultrio试剂检测1 465 864例血液标本,核酸联检单反应性率和核酸鉴别反应性率分别为0.22%和29.21%,UltrioPlus试剂检测261 238例血液标本,核酸联检单阳性率和鉴别阳性率分别为0.33%、39.12%,两指标与Ultrio试剂比较,差异有统计学意义（χ2=92.58,P〈0.01;χ2=31.07,P〈0.01）;2016年2—3月,采用NAT/EIA平行检测模式,UltrioPlus试剂检测血液标本51 686例,核酸联检单反应性率、核酸鉴别反应性率和HBV DNA检出率分别为：0.57%、22.90%和0.13%;2016年4—12月,采用先EIA后NAT检测模式,UltrioPlus核酸试剂检测血液标本208 962例,核酸联检单反应性率、鉴别反应性率和HBV DNA检出率分别为：0.27%、47.73%和0.13%,2种血液检测模式的核酸联检单反应性率和鉴别反应性率比较,差异有统计学意义（χ2=117.90,P〈0.01;χ2=50.15,P〈0.01）,HBV DNA检出率相同（0.13%）。结论新一代核酸试剂UltrioPlus相比Ultiro有更高的检测灵敏度和特异性,采用先EIA后NAT检测模式较EIA/NAT平行检测模式能有效减低实验室污染,减少血液核酸检测假阳性的发生。Objective To investigate the reaction rate of nucleic acid test（ NAT） in Tigris system when using ultrioplus and ultrio assasys and in different screening modes. Methods The data of NAT and EIA tests in 2011—2016 was reviewed and analyzed. The reaction rates of sero-negative blood samples were compared when using ultrioplus and ultrio assasys. In addition,the reaction rates and confirming positive rate for HBV,HCV and HIV-1 were compared between parallel test mode and the EIA-NAT mode,which runs the EIA test firstly and then the sero-negative samples were selected to run NAT test.Results During the period between 2011 and 2015,1 412 432 donations were tested in parallel mode using Ultrio assay.The reaction rate,confirming positive rate for the three viruses and for HBV were 0. 23%、29. 20% and 0. 07%,respectively.And the difference of reaction rate and confirming positive rate between the five years were P〈0. 05（ χ2= 9. 80） and P〈0. 05（ χ2= 3. 91）,respectively. Ultrio assays was used to detect 1 465 864 donations,the reaction rate,confirming positive rate for the three viruses were 0. 22% and 29. 21%,respectively. Ultrioplus detecting 261 238 donations,the reaction rate,confirming positive rate for the three viruses were 0. 33% and 39. 12%,respectively. The indexes between Ultrio and Ultrioplus were statistically significant diference,respectively（ χ2= 92. 58,P〈0. 01; χ2= 31. 07,P〈0. 01）. From Feb 2016 to Mar 2016,51 686 donations were detected in parallel mode using Ultrio Plus assay. The reaction rate,confirming positive rate for the three viruses and for HBV were 0. 57%、22. 90% and 0. 13%,respectively. From Apr 2016 until Dec 2016,208962 donations were detected in EIA-NAT mode using Ultrio Plus assay. The reaction rate,confirming positive rate for the three viruses and for HBV were 0. 27%、47. 73% and 0. 13%,respectively.The reaction rate and confirming positive rate for the three viruses were significantly different between the parallel mode and the EIA-NAT mode（ χ2= 117.

关 键 词：血液核酸检测 酶联免疫试验 检测模式 假阳性 

分 类 号：R446.11[医药卫生—诊断学] Q503[医药卫生—临床医学]