2种核酸筛查系统对血清学阳性献血者检测结果的分析  

Comparative analysis of two nucleic acid test systems in seropositive blood donors

作　　者：王立林[1] 卢亮[1] 聂冬梅[1] 杜鹏[1] 郑欣[1] 叶贤林[1] 蔡云玲 卢曼萍[1] 曾劲峰[1] 杨宝成[1] 

机构地区：[1]深圳市血液中心,广东深圳518035

出　　处：《中国输血杂志》2015年第9期1090-1093,共4页Chinese Journal of Blood Transfusion

基　　金：深圳市科技创新委员会项目(JCYJ20140403093211510);深圳市科卫生计生系统科研项目(201401074)

摘　　要：目的比较2种核酸筛查系统对血清学阳性标本的检测结果,分析不同核酸筛查系统不同核酸试剂降低输血残余风险的情况。方法对2013年8月5日—2013年9月1日共计6 889人(次)无偿献血者的血液标本进行血清学检测,同时平行进行HBV/HCV/HIV的3项联合单标本核酸定性检测(美国诺华核酸检测平台,Procleix Ultrio试剂)。血清学HBs Ag、抗-HCV、抗-HIV阳性标本用阴性血浆稀释6倍,模拟混合标本(美国罗氏核酸检测平台,cobas Taq Screen MPX试剂)检测核酸。血清学HBs Ag阳性标本完善血清学乙肝5项,同时用另1家公司HBs Ag酶联免疫吸附试剂重复试验;抗-HCV阳性标本应用重组免疫印迹试验(RIBA)确证;抗-HIV阳性标本采用HIV蛋白印迹法确证。分析不同核酸筛查平台使用不同核酸试剂检测血清学阳性献血者的结果。结果酶免阳性标本6倍稀释后,MPX试剂与Ultrio试剂阳性检测一致率100%。2种核酸试剂对HBV DNA检测结果一致性中等(K=0.640),检出率差异有统计学意义(P<0.001);对HCV RNA及HIV RNA检测结果一致性非常好(K=1.000)。2种核酸试剂一致检出的HCV RNA反应性样品及HIV RNA反应性标本,确证试验均为阳性。45份HBs Ag阳性标本,Ultrio试剂检测阴性MPX试剂检测阳性标本共有7例,1例HBs Ag酶免S/CO值介于1.0-2.0,6例S/CO值>1.8。另1种进口HBs Ag酶联免疫试剂盒检测,7例2种NAT结果不一致标本中6例阳性,1例阴性。其中2名在6个月后复检,酶免及2种核酸检测结果均为阳性。结论 HBs Ag阳性献血者中,MPX试剂HBV DNA检出率高于Ultrio试剂;抗-HCV与抗-HIV阳性献血者中,HCV RNA和HIV RNA检出率MPX试剂与Ultrio试剂差异不显著。血液筛查工作中,核酸检测与血清学检测结果存在不一致,应重视血清学检测试剂与核酸检测方法试剂的选择和质量控制,使二者互补,降低由于核酸检测灵敏度相对较低导致的漏检。Objective To evaluate the current value of two different nucleic acid test （NAT） systems and serological screening in reducing the risk in blood transfusion. Methods The Procleix Ultrio （Uhrio） assay were used to test 6 889 people （ number of times） who were volunteer blood donors from August 5, 2013 to September 1,2013. The routine serological testing was performed in parallel processing. Seropositive samples were further tested in minipools of 6 （MP6） donations by diluted negative plasma with the cobas s201 （MPX）. To accomplish the serological test and another HBsAg ELISA assay for HBsAg positive samples, recombinant immunoblot assay （ RIBA ） were used for detecting anti-HCV positive samples, western-blot assay for anti-HIV samples. The relationship between two NAT results and serological test outcomes was explored. Results All the seropositive samples detected by Uhrio-ID were in accordance with the MPX-MP6. It showed mod- erate concordance between the two NATs for detecting HBV DNA （K = 0. 640, P 〈 0. 001 ）, high concordance for HCV RNA and HIV RNA detection （ K = 1. 000, P 〈 0. 05 ）. HCV RNA and HIV RNA samples yielded by two NATs were identified by Western Blot. Seven samples were reactive on the cobas MPX test but nonreactive tot Ultrio of 45 HBsAg positive samples, l case HBsAg had an S/CO value between 1.0 and 2.0 and the other 6 samples had values of higher than 1.8. Two out of 7 follow up samples collected 6 months later were HBsAg positive and HBV DNA were reactive in both Ultrio and MPX. Con-clusion Detection rate of MPX is higher than that of Ultrio in HBsAg positive samples, while the difference of HCV RNAand HIV RNA detection rate for both methods is not significant in anti-HCV and anti-HIV positive blood donors. There arediscordance between serological screening and NAT. More attention should be paid to the selection of NAT methods and serological reagents, quality control, such that missing detection could be avoided due to relatively lower nucleic acid detect

关 键 词：核酸检测 血清学检测 ELISA Ultrio MPX 血液安全 

分 类 号：R446.6[医药卫生—诊断学]