HIV 1/2抗体快速诊断试剂分析灵敏度评价
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摘要
目的对艾滋病病毒(HIV)抗体快速检测试剂盒进行分析灵敏度的评估,为今后试剂的质量提高及用户选择提供参考。方法用构建的性能血清盘和稀释系列血清盘来评价8种快速检测试剂,通过免疫层析判读仪进行结果的读值,然后对结果进行统计分析。结果 A、B、C、D、E、F、G、H 8种试剂检测性能血清盘结果显示:C、D、E、F、G、H 6种试剂的阳性检出率均达到20/20,且GOD值均较高(反应强度较高);2种试剂存在漏检的现象,GOD值均较低(反应强度较弱)。检测稀释系列血清盘结果显示,4种试剂对稀释后的弱阳性样本分析灵敏度较高,其他4种试剂分析灵敏度较低。随着样本稀释倍数的增加,抗体浓度的降低,检测出的GOD值也逐渐下降。当抗体浓度相同时,各个试剂之间的GOD值呈现差异;GOD值较高的试剂检测弱阳性样本的灵敏度更高。结论不同HIV抗体快速检测试剂盒在分析灵敏度方面存在差异。试剂在使用前,使用者应加强对试剂性能的验证,选择分析灵敏度较高的HIV抗体快速诊断试剂,提高实验室阳性检出率,及早发现HIV感染者。
Objective To evaluate the analytic sensitivity of HIV-1/2 antibody rapid diagnostic reagents and to improve the testing quality. Methods The performance panel and the linearity panel were constructed and used to evaluate the eight kinds of HIV-1/2 antibody rapid diagnostic kits. Then the results were read by immuno-chromatographic assay reader and analyzed. Results According to the results of the performance panel, six kits had the same positive rates of 20/20 and higher values of GOD than the other two with undetected probability and lower values of GOD. According to the results of the linearity panel, analytic sensitivity of four kits able to detect the weak positive samples was higher than that of the others. With increase of multiple dilution of the samples, and decrease of the concentration of HIV-1/2 antibodies, the value of GOD were gradually decreasing. When all kits were used to detect the same samples, there were different values of GOD, and the analytic sensitivity of the kits with high values of GOD was higher and could detect weaker positive samples. Conclusion HIV-1/2 antibody rapid diagnostic reagents differ greatly in the analysis sensitivity. Users should evaluate the performance of HIV-1/2 antibody rapid diagnostic reagents before using them and choose the better one. This will help increase the detection rate and timely find people living with HIV.
Objective To evaluate the analytic sensitivity of HIV-1/2 antibody rapid diagnostic reagents and to improve the testing quality. Methods The performance panel and the linearity panel were constructed and used to evaluate the eight kinds of HIV-1/2 antibody rapid diagnostic kits. Then the results were read by immuno-chromatographic assay reader and analyzed. Results According to the results of the performance panel, six kits had the same positive rates of 20/20 and higher values of GOD than the other two with undetected probability and lower values of GOD. According to the results of the linearity panel, analytic sensitivity of four kits able to detect the weak positive samples was higher than that of the others. With increase of multiple dilution of the samples, and decrease of the concentration of HIV-1/2 antibodies, the value of GOD were gradually decreasing. When all kits were used to detect the same samples, there were different values of GOD, and the analytic sensitivity of the kits with high values of GOD was higher and could detect weaker positive samples. Conclusion HIV-1/2 antibody rapid diagnostic reagents differ greatly in the analysis sensitivity. Users should evaluate the performance of HIV-1/2 antibody rapid diagnostic reagents before using them and choose the better one. This will help increase the detection rate and timely find people living with HIV.
引文
[1]中国疾病预防控制中心性病艾滋病预防控制中心性病控制中心.2016年8月全国艾滋病性病疫情[J].中国艾滋病性病,2016,22(10):767.
[2]邢文革,蒋岩.HIV抗体快速检测试验的临床应用[J].中华医学实践杂志,2005,4(1):24-26.
[3]朱伟光,陈尚林,戚晓飞,等.宿迁地区HIV抗体快速检测试剂性能评估[J].江苏预防医学,2016,27(4):486-487.
[4]李桓,王静,付晓,等.HIV抗体快速检测的临床意义探讨[J].儿科药学杂志,2013,19(8):3-5.
[5]中国疾病预防控制中心.全国艾滋病检测技术规范(2015年修订版)[S].2015.
[6]陈会超,冯瑞林,杨朝军,等.联合3种快速试剂用于HIV感染诊断的可行性探讨[J].中国艾滋病性病,2017,23(3):251-253.
[7]中国疾病预防控制中心.2015年全国艾滋病病毒抗体诊断试剂临床质量评估报告[EB/OL].http://www.chinaaids.cn/sysjc/jswjl/201510/t20151009_120929.htm.
[8]戴洁,杨莉,马艳玲,等.2010-2012年HIV抗体诊断试剂质量评估结果分析[J].中国艾滋病性病,2015,21(6):529-532.
[9]朱伟光,衬衫领,戚晓飞,等.宿迁地区HIV抗体快速检测试剂性能评估[J].江苏预防医学,2016,27(4):486-487.
[10]韦兴强,韦东禄,邱涛.HIV抗体快速检测现状及其推广应用[J].中国保健营养,2012,22(9):3561-3562.
[11]余育胜,王槐堂,郑曦.抗凝剂EDTA2K2对胶体硒免疫层析试验的影响[J].中国艾滋病性病,2008,14(1):60-61.
[12]陈远林,秦立新,张仁生.抗-HIV初筛试验阳性结果分析[J].实用预防医学,2006,13(2):284-286.
[13]程玉萍,鲁然,许亚辉.国产ELISA试剂检测抗-HIV假阳性原因分析[J].中国误诊学杂志,2004,4(1):54-55.
[14]陈兵,王美玉,裴丽健,等.HIV抗体快速诊断室内质控品的制备及应用[J].中国艾滋病性病,2015,21(7):635-638.
[2]邢文革,蒋岩.HIV抗体快速检测试验的临床应用[J].中华医学实践杂志,2005,4(1):24-26.
[3]朱伟光,陈尚林,戚晓飞,等.宿迁地区HIV抗体快速检测试剂性能评估[J].江苏预防医学,2016,27(4):486-487.
[4]李桓,王静,付晓,等.HIV抗体快速检测的临床意义探讨[J].儿科药学杂志,2013,19(8):3-5.
[5]中国疾病预防控制中心.全国艾滋病检测技术规范(2015年修订版)[S].2015.
[6]陈会超,冯瑞林,杨朝军,等.联合3种快速试剂用于HIV感染诊断的可行性探讨[J].中国艾滋病性病,2017,23(3):251-253.
[7]中国疾病预防控制中心.2015年全国艾滋病病毒抗体诊断试剂临床质量评估报告[EB/OL].http://www.chinaaids.cn/sysjc/jswjl/201510/t20151009_120929.htm.
[8]戴洁,杨莉,马艳玲,等.2010-2012年HIV抗体诊断试剂质量评估结果分析[J].中国艾滋病性病,2015,21(6):529-532.
[9]朱伟光,衬衫领,戚晓飞,等.宿迁地区HIV抗体快速检测试剂性能评估[J].江苏预防医学,2016,27(4):486-487.
[10]韦兴强,韦东禄,邱涛.HIV抗体快速检测现状及其推广应用[J].中国保健营养,2012,22(9):3561-3562.
[11]余育胜,王槐堂,郑曦.抗凝剂EDTA2K2对胶体硒免疫层析试验的影响[J].中国艾滋病性病,2008,14(1):60-61.
[12]陈远林,秦立新,张仁生.抗-HIV初筛试验阳性结果分析[J].实用预防医学,2006,13(2):284-286.
[13]程玉萍,鲁然,许亚辉.国产ELISA试剂检测抗-HIV假阳性原因分析[J].中国误诊学杂志,2004,4(1):54-55.
[14]陈兵,王美玉,裴丽健,等.HIV抗体快速诊断室内质控品的制备及应用[J].中国艾滋病性病,2015,21(7):635-638.