血液HIV、HBV和HCV筛查策略的探讨  

Discussion on screening strategy for human immunodeficiency virus,hepatitis C virus and hepatitis B in blood donations

作　　者：黄成垠[1] 蒋昵真[1] 陈显[1] 朱绍汶[1] 胡文佳[1] 

机构地区：[1]江苏省血液中心,江苏南京210042

出　　处：《中国输血杂志》2015年第7期784-786,共3页Chinese Journal of Blood Transfusion

基　　金：江苏省卫生厅面上项目(H201332)

摘　　要：目的比较2种ELISA试剂加1种NAT试剂与1种ELISA试剂加1种NAT试剂筛查血液HBV、HCV、HIV的实验效果。方法以126 457(人)份献血者标本为检测对象,采用A、B 2种国产ELISA试剂平行检测其抗-HIV-1/2和抗-HCV,A、C 2种国产的ELISA试剂平行检测HBs Ag,以1种进口的NAT检测系统及配套试剂检测HBV DNA、HIV RNA和HCV RNA。对ELISA单试剂反应性、NAT阴性的标本做血清学确证试验,阳性者给予追踪随访。结果在本组献血者标本中共检出ELISA单试剂反应性、NAT阴性标本的比例为2.78‰(352/126 457),血清学确证试验阳性率0.13‰(17/126 457),其中抗-HCV:A试剂反应性79例,确证试验(RIBA)阳性1例,随访3个月后仍为阳性;B试剂反应性36例,RIBA阳性4例,随访3个月后,4例中RIBA试验1例转为阴性,1例转为不确定,2例仍为阳性。HBs Ag:A试剂反应性比例为0.88‰(112/126 457),确证试验(中和试验)阳性率0.09‰(11/126 457),有8例实现成功随访,3个月后2例转为阴性,1例转为A和C双试剂反应性,但NAT阴性、中和试验阳性,5例仍为A试剂反应性及中和试验阳性、但4例NAT转为阳性;C试剂反应性比例0.03‰(37/126 457),中和试验阳性率0.01‰(1/126 457),3个月后随访仍为阳性。抗-HIV-1/2:ELISA单试剂反应性、NAT阴性比例为0.69‰(88/126457),确证试验(WB)均为阴性。HBs Ag ELISA A试剂反应性、NAT阳性比例0.04‰(5/126 457);未检出抗-HIV-1/2、抗-HCV ELISA单试剂反应性伴NAT阳性标本。结论 1种ELISA试剂加1种NAT试剂的血液筛查模式,其HCV和HBV的残余风险高于2种ELISA试剂加1种NAT试剂,而2种试剂模式检测HIV的残余风险没有差别。Objective To evaluate and compare the influence of blood screening either by two rounds of ELISA combined with NAT or one round of ELISA with NAT. Methods To test 126 457 samples,domestic antibodies of HIV-1 /2 and HCV kits produced by company A and B were used for two rounds of ELISA detection,while HBs Ag kits produced by company A and C were used for HBs Ag detection. NAT of HCV / HIV / HBV was implemented by a foreign detection system and its matched reagent. Samples which were tested reactive by single ELISA reagent but non-reactive by NAT were further tested by confirmatory tests. For those samples with positive confirmatory results,their donors were followed up. Results Among 126457 blood donations,of which,2. 78‰（ 352 /126 457） were single ELISA reagent reactive and NAT non-reactive,while0. 13‰（ 17 /126 457） were serological confirmatory positive. As for anti-HCV,79 were reactive by reagent A,of which only1 was positive by confirmatory test（ RIBA） and the follow up result of the donor was still positive three months later. While36 were anti-HCV reactive by reagent B,of which,4 were RIBA positive. Two of the 4 donors followed up 3 months later were still positive,while 1 turned negative and 1 was undetermined. As for HBs Ag,0. 88‰（ 112 /126 457） were reactive by reagent A and 0. 09‰（ 11 /126 457） were positive by confirmatory test（ neutralization test）. 8 donors were followed up,of whom,2 turned negative. 1 became HBs Ag reactive by A and C and neutralization test positive but non-reactive by NAT. 5were still reactive by A and neutralization test positive,of which 4 were NAT reactive. 0. 03%（ 37 /126 457） were HBs Ag reactive by reagent C. Only 1（ 0. 01‰,1 /126 457） was positive by neutralization test and its donor followed up 3 months later remained positive. As for anti-HIV 1 /2,0. 69‰（ 88 /126 457） were single ELISA reagent reactive and NAT non-reactive but all negative by confirmatory test（ WB）. Generally,0. 04‰（ 5 /126 457） were HBs Ag reactive

关 键 词：核酸检测 酶联免疫检测 血液筛查策略 HCV HBV HIV 献血者 

分 类 号：R446[医药卫生—诊断学] R512.6[医药卫生—临床医学]