ELISA法检测抗-HIV灰区设置的探讨
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摘要
目的探讨采用ELISA法对无偿献血者进行抗-HIV筛查所设灰区的合理性。方法回顾分析本站2014年1月1日～2017年12月31日无偿献血者抗-HIV有反应性和灰区(0.5≤s/co<1)标本,以市疾病控制中心对其确认结果作为金标准,绘制ROC曲线,比较不同s/co情况下试剂灵敏度和特异性的变化。随机抽取20份抗-HIV非反应性标本(s/co≤0.5)做WB确认,确定是否有阳性标本漏检。结果万泰试剂对39991标本检测出有反应性标本26份,灰区22份;丽珠试剂检测出有反应性15份,灰区标本7份;市疾病控制中心共确认5例为阳性;所有灰区标本经确认均阴性;20例无反应性标本确认均阴性。结论试剂厂商提供的s/co值具有较高灵敏度,满足血液筛查要求,但是设置的灰区造成不必要的血液浪费。
Objective To explore the rationality of the grey zone determination in anti-HIV detections by ELISA in screening of blood donation.Methods A retrospective analysis was performed with anti-HIV positive and grey zone(0.5≤s/co<1) specimens that were subsequently subjected to Tongling Center for Disease Control for confirmation from January2014 to December 2017.The ROC curve was used to compare the sensitivity and specificity of the reagents under different s/co conditions.Twenty negative specimens of anti-HIV(s/co<0.5) were randomly selected for WB tests.Results A total of39991 specimens were tested by the reagents from Wantai company,and 26 positive specimens and 22 grey zone specimens were found.Fifteen positive and 7 grey zone specimens were detected out by the reagents provided by Lizhu company.Among them,however,only 5 specimens were confirmed to be positive by Tongling CDC.Conclusion The over-sensitive values of s/co recommended by the reagent manufacturers for blood screening is able to meet our requirements and the setting of grey zone may cause unnecessary waste of donated blood.
Objective To explore the rationality of the grey zone determination in anti-HIV detections by ELISA in screening of blood donation.Methods A retrospective analysis was performed with anti-HIV positive and grey zone(0.5≤s/co<1) specimens that were subsequently subjected to Tongling Center for Disease Control for confirmation from January2014 to December 2017.The ROC curve was used to compare the sensitivity and specificity of the reagents under different s/co conditions.Twenty negative specimens of anti-HIV(s/co<0.5) were randomly selected for WB tests.Results A total of39991 specimens were tested by the reagents from Wantai company,and 26 positive specimens and 22 grey zone specimens were found.Fifteen positive and 7 grey zone specimens were detected out by the reagents provided by Lizhu company.Among them,however,only 5 specimens were confirmed to be positive by Tongling CDC.Conclusion The over-sensitive values of s/co recommended by the reagent manufacturers for blood screening is able to meet our requirements and the setting of grey zone may cause unnecessary waste of donated blood.
引文
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4陈静,李帮芬,先秀,等.酶联免疫四项检测结果灰区与窗口期感染的关系[J].检验医学与临床,2017,14(17):2554-2556.
5吕蒙恩,凌霞.献血者HIV1/2血清学ELISA检测初筛灰区标本的结果分析[J].中国输血杂志,2017,30(12):1387-1388.
6岳献荣,孟毓,秦小敏.从无偿献血者HIV确证结果探讨灰区的设置[J].中国卫生产业,2015,21:189-190.
7陈显,胡文佳,黄成垠,等.献血者ELISA检测为灰区标本的确证试验与核酸检测情况分析[J].中国输血杂志,2015,28(2):198-199.
8王庆敏,冯晨晨,将昵真,等.常用抗-H I V、抗-TPELISA血液筛查试剂盒阳性判断值得验证[J].中国输血杂志,2017,30(8):904-906.
9郭宏.抗-HIV ELISA检测结果分析及灰区设置研究[J].中国卫生检验杂志,2018,28(6):691-693.
10姚栋,肖珊,张如胜,等.第四代HIV初筛试剂在血液筛查种的应用评价[J].实用预防医学,2012,19(10):1567-1568.
11马晓旭.第四代HIV检测试剂与第三代HIV检测试剂的结果比较[J].中国医药指南,2016,14(4):154-155.
2高景波.HIV酶联免疫吸附试验检测设置灰区的必要性[J].中国艾滋病性病,2016,22(12):1009-1010.
3冯晓丹,叶莉莉,高玲娟,等.人类免疫缺陷病毒抗体检测“灰区”设置的探讨[J].检验医学与临床,2015,12(22):3332-3333.
4陈静,李帮芬,先秀,等.酶联免疫四项检测结果灰区与窗口期感染的关系[J].检验医学与临床,2017,14(17):2554-2556.
5吕蒙恩,凌霞.献血者HIV1/2血清学ELISA检测初筛灰区标本的结果分析[J].中国输血杂志,2017,30(12):1387-1388.
6岳献荣,孟毓,秦小敏.从无偿献血者HIV确证结果探讨灰区的设置[J].中国卫生产业,2015,21:189-190.
7陈显,胡文佳,黄成垠,等.献血者ELISA检测为灰区标本的确证试验与核酸检测情况分析[J].中国输血杂志,2015,28(2):198-199.
8王庆敏,冯晨晨,将昵真,等.常用抗-H I V、抗-TPELISA血液筛查试剂盒阳性判断值得验证[J].中国输血杂志,2017,30(8):904-906.
9郭宏.抗-HIV ELISA检测结果分析及灰区设置研究[J].中国卫生检验杂志,2018,28(6):691-693.
10姚栋,肖珊,张如胜,等.第四代HIV初筛试剂在血液筛查种的应用评价[J].实用预防医学,2012,19(10):1567-1568.
11马晓旭.第四代HIV检测试剂与第三代HIV检测试剂的结果比较[J].中国医药指南,2016,14(4):154-155.