开展核酸检测后凉山地区献血者HIV/HBV/HCV筛查策略探讨  

Study of the screening strategy for HIV / HBV / HCV in blood donors with nucleic acid testing( NAT)

作　　者：王胜蓝 吉克春农 魏禄川 杨冬 王剑 王兵 谭冬黎 付萍[2] 刘鱼[2] 

机构地区：[1]凉山州中心血站,四川西昌615000 [2]中国医学科学院北京协和医学院输血研究所

出　　处：《中国输血杂志》2016年第7期679-681,共3页Chinese Journal of Blood Transfusion

基　　金：四川省科技支撑项目(2014SZ0239);四川省民族地区医学重点专科(实验室)建设项目;(20120108)

摘　　要：目的探讨开展核酸检测后适合本地区传染病流行特征的献血者HIV/HBV/HCV筛查策略。方法收集本站开展NAT前后各2年献血者筛查数据及标本,分别为37 428和40 020份,对NAT阴性、单试剂ELISA阳性477份标本做补充试验和确证检测,对检测结果进行分析。结果开展NAT前后本地区献血者的HBs Ag、抗-HCV、抗-HIV阳性率分别为1.12%(64/37 428)vs 1.06%(423/40 020)、0.67%(250/37 428)vs 0.53%(212/40 020)(P<0.05)、0.50%(189/37 428)vs 0.41%(163/40 020)(P<0.05)。开展NAT后,3项指标ELISA检出总阳性率1.99%(798/40 020),NAT联检阳性率0.74%(276/40 020),ELISA与NAT联检同时阳性率0.53%(211/40 020);ELISA阴性标本中,NAT联检阳性率为0.21%(85/40 020),鉴别试验阴性比例70.59%(60/85),阳性比例29.41%(25/85),其中HBV DNA阳性率0.057%(23/40 020)、HIV RNA及HCV RNA阳性率均为0.002%(1/40 020);NAT阴性标本中,ELISA双试剂检测阳性率为0.17%(67/40 020),ELISA单试剂检测阳性率为1.30%(520/40 020),其中HBs Ag阳性率为0.55%(220/40 020)、抗-HCV阳性率为0.40%(160/40 020),抗-HIV阳性率为0.35%(140/40020)。对520份单试剂阳性标本中的477份标本做确证检测,HBs Ag阳性17份、抗-HCV阳性9份、抗-HIV阳性1份。结论本地区开展献血者NAT的HIV/HBV/HCV筛查对减低输血残余风险具有重要意义;若采用ELISA单试剂检测加NAT检测的模式,需对ELISA方法和试剂做谨慎评估。Objectives To evaluate the effect of the application of NAT on blood screening in Liangshan and to explore the most effective screening strategy for HIV / HBV / HCV according to the epidemiological characteristics of infectious diseases in this region. Methods The data on blood screening two years before and two years after implementation of NAT were collected. 37 428 and 40 020 samples were screened and collected. Supplemental and confirmatory testing were conducted on the477 samples tested negative by NAT but reactive by any one of the two ELISA assays. The testing results were compared and analyzed. Results The positive rate of HBs Ag,anti-HCV and anti-HIV before and after NAT implementation included in screening was 1. 12%（ 64 /37 428） and 1. 06%（ 423 /40 020）（ P 〉 0. 05）,0. 67%（ 250 /37 428） and 0. 53%（ 212 /40020）（ P 〈 0. 05）,0. 50%（ 189 /37 428） and 0. 41%（ 163 /40 020）（ P 〈 0. 05） respectively. The positive rate of both anti-HCV and anti-HIV before NAT was included was higher than that after NAT was included. A total of 798（ 1. 99%）samples were screened positive for HBs Ag,anti-HCV or anti-HIV by ELISA,296（ 0. 74%） samples were tested positive by simultaneous testing of HIV / HBV / HCV NAT and 211（ 0. 53%） samples were tested positive by both ELISA and NAT. Among the samples tested negative by ELISA,the positive rate by multiplex NAT was 0. 21%（ 85 /40 020）,and among which,70. 59%（ 60 /85） negative and 29. 41%（ 25 /85） were tested positive by discriminatory assay. 0. 057%（ 23 /40020） were positive for HBV DNA,while 0. 002%（ 1 /40 020） was positive for HIV RNA and HCV RNA respectively. Among the samples tested negative by multiplex NAT,0. 17%（ 67 /40 020） were tested reactive by both ELISA assays,and1. 30%（ 520 /40 020） were tested reactive by any one of the two ELISA assays. The rates of the samples screened reactive for HBs Ag,anti-HCV and anti-HIV were 0. 55%（ 220 /40 020）,0. 40%（ 160 /40 020） and 0. 35%（ 140 /40

关 键 词：乙型肝炎病毒 丙型肝炎病毒 人类免疫缺陷病毒 酶联免疫检测 核酸检测 血液筛查 残余风险 筛查策略 

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