2种酶联免疫试剂和核酸同步筛查HIV的策略评价
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摘要
目的评价酶联免疫法(ELISA)第三代试剂、第四代试剂和核酸同步检测无偿献血者人类免疫缺陷病毒(HIV)的检测策略。方法采用1种第三代、1种第四代ELISA试剂和1种核酸检测试剂分别对2016年1月至2017年6月无偿献血者血浆样本进行平行检测。初筛结果为反应性的标本送检至确证实验室,采用免疫印迹法(WB)进行HIV-1抗体确证。结果第三代抗-HIV诊断ELISA试剂与WB的阳性符合率为72.11%;第四代抗-HIV诊断ELISA试剂与WB的阳性符合率为37.06%;核酸检测与WB的阳性符合率为93.04%;3种方法同步检测与WB的阳性符合率为100.00%。结论使用ELISA第三代与第四代HIV筛查试剂和核酸同步检测可以提高筛查无偿献血者HIV的能力,降低经血传播HIV的风险。
Objective To evaluate the blood screening strategy of human immunodeficiency virus(HIV)in volutary unpaid blood donors with third generation,fourth generation reagents enzyme-linked immunosorbent assay(ELISA)reagents and nucleic acid test.Methods One third generation anti-HIV ELISA reagent,one fourth generations HIV antigen-anti-HIV co-diagnose ELISA reagent and one viral nucleic acid test reagent were used for detecting the plasma samples of blood donors in parallel.The samples which considered reactive results of the screening test were confirmed by the Western blot(WB).Results The positive rate of third generation anti-HIV diagnostic ELISA reagent and WB was 72.11%,the positive rate of fourth generation anti-HIV diagnostic ELISA reagent and WB was 37.06%,the positive rate of nucleic acid detection and WB was93.04%,while the positive coincidence rate between the three methods of synchronous detection and WB was100.00%.Conclusion The use of synchronous detection of the third and fourth generation HIV screening reagents and nucleic acid detection can improve blood donation screening ability of HIV,and reduce the risk of transfusion transmitted HIV.
Objective To evaluate the blood screening strategy of human immunodeficiency virus(HIV)in volutary unpaid blood donors with third generation,fourth generation reagents enzyme-linked immunosorbent assay(ELISA)reagents and nucleic acid test.Methods One third generation anti-HIV ELISA reagent,one fourth generations HIV antigen-anti-HIV co-diagnose ELISA reagent and one viral nucleic acid test reagent were used for detecting the plasma samples of blood donors in parallel.The samples which considered reactive results of the screening test were confirmed by the Western blot(WB).Results The positive rate of third generation anti-HIV diagnostic ELISA reagent and WB was 72.11%,the positive rate of fourth generation anti-HIV diagnostic ELISA reagent and WB was 37.06%,the positive rate of nucleic acid detection and WB was93.04%,while the positive coincidence rate between the three methods of synchronous detection and WB was100.00%.Conclusion The use of synchronous detection of the third and fourth generation HIV screening reagents and nucleic acid detection can improve blood donation screening ability of HIV,and reduce the risk of transfusion transmitted HIV.
引文
[1]中华人民共和国国家卫生和计划生育委员会.国家卫生计生委关于印发血站技术操作规程(2015版)的通知[EB/OL].2015-12-17[2018-04-11].http://www.nhfpc.gov.cn/yzygj/s7658/201512/d9c 61cbe 48c14b88ab 82ebae72036223.shtml.
[2]周国平,王迅,任亚娜,等.血液筛查策略的选择要因地制宜[J].中国输血杂志,2015,28(1):108-110.
[3]王迅.采供血机构开展血液病毒核酸检测的条件及意义[J].中国输血杂志,2008,21(11):825-826.
[4]曾劲峰,郑欣,许晓绚.ELISA检测与NAT在血液筛查应用中的互补性研究[J].中国输血杂志,2012,25(10):1012-1014.
[5]王胜蓝,吉克春农,魏禄川,等.开展核酸检测后凉山地区献血者HIV/HBV/HCV筛查策略探讨[J].中国输血杂志,2016,29(7):679-681.
[6]梁启忠,掌友湖,程玉根.第4代与第3代HIV检测试剂质量比较[J].临床血液学杂志(输血与检验),2010,23(3):356-358.
[7]于茂河,柳忠泉,夏建晖,等.两代酶联免疫试剂在男男性行为人群HIV检测中的应用[J].中国艾滋病性病,2012,18(4):242-244.
[8]冯健亮,翁远桥,陈日明,等.2种酶联免疫试剂筛查血液抗-HIV应用比较[J].中国输血杂志,2012,25(6):568-569.
[9]许四宏,李秀华,宋爱京,等.第4代HIV抗原抗体联合检测试剂的评价[J].中国输血杂志,2006,19(3):188-191.
[10]程绍辉,赵璇,周宁,等.采用四代试剂结合核酸检测方法早期发现HIV感染者的检测策略[J].中国艾滋病性病,2015,21(5):358-360.
[11]薛文颖,王瑞丽,许丹,等.沧州血站筛查抗-HIV的两种ELISA试剂质量的评估[J].河北医药,2014,36(13):2046-2047.
[12]王丽梅,池泉,林授,等.无偿献血者HIV检测和归队情况分析[J].中国输血杂志,2017,30(8):901-903.
[13]黄力勤,查祎,姚凤兰,等.无偿献血人群HIV检测结果多样性分析[J].中国输血杂志,2016,29(5):505-508.
[14]余谨,毕昊,陆华新,等.核酸检测技术在酶联免疫吸附法漏检HIV和HBV血样筛查中的应用[J].国际检验医学杂志,2012,33(8):964-965.
[15]李玲,牛丽彬,朱邵汶,等.中国采供血机构抗-HIV/HIV核酸筛查阳性献血者确证策略研究[J].中国输血杂志,2015,28(9):1118-1121.
[2]周国平,王迅,任亚娜,等.血液筛查策略的选择要因地制宜[J].中国输血杂志,2015,28(1):108-110.
[3]王迅.采供血机构开展血液病毒核酸检测的条件及意义[J].中国输血杂志,2008,21(11):825-826.
[4]曾劲峰,郑欣,许晓绚.ELISA检测与NAT在血液筛查应用中的互补性研究[J].中国输血杂志,2012,25(10):1012-1014.
[5]王胜蓝,吉克春农,魏禄川,等.开展核酸检测后凉山地区献血者HIV/HBV/HCV筛查策略探讨[J].中国输血杂志,2016,29(7):679-681.
[6]梁启忠,掌友湖,程玉根.第4代与第3代HIV检测试剂质量比较[J].临床血液学杂志(输血与检验),2010,23(3):356-358.
[7]于茂河,柳忠泉,夏建晖,等.两代酶联免疫试剂在男男性行为人群HIV检测中的应用[J].中国艾滋病性病,2012,18(4):242-244.
[8]冯健亮,翁远桥,陈日明,等.2种酶联免疫试剂筛查血液抗-HIV应用比较[J].中国输血杂志,2012,25(6):568-569.
[9]许四宏,李秀华,宋爱京,等.第4代HIV抗原抗体联合检测试剂的评价[J].中国输血杂志,2006,19(3):188-191.
[10]程绍辉,赵璇,周宁,等.采用四代试剂结合核酸检测方法早期发现HIV感染者的检测策略[J].中国艾滋病性病,2015,21(5):358-360.
[11]薛文颖,王瑞丽,许丹,等.沧州血站筛查抗-HIV的两种ELISA试剂质量的评估[J].河北医药,2014,36(13):2046-2047.
[12]王丽梅,池泉,林授,等.无偿献血者HIV检测和归队情况分析[J].中国输血杂志,2017,30(8):901-903.
[13]黄力勤,查祎,姚凤兰,等.无偿献血人群HIV检测结果多样性分析[J].中国输血杂志,2016,29(5):505-508.
[14]余谨,毕昊,陆华新,等.核酸检测技术在酶联免疫吸附法漏检HIV和HBV血样筛查中的应用[J].国际检验医学杂志,2012,33(8):964-965.
[15]李玲,牛丽彬,朱邵汶,等.中国采供血机构抗-HIV/HIV核酸筛查阳性献血者确证策略研究[J].中国输血杂志,2015,28(9):1118-1121.