HIV抗体无创(口腔黏膜渗出液及尿液)检测试剂与有创(血液)检测试剂的性能比较
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摘要
目的本研究以凉山州彝族人群作为研究对象,评价3种人类免疫缺陷病毒(HIV)抗体无创(口腔黏膜渗出液及尿液)检测试剂的检测性能。方法 2017年10月至2018年3月招募凉山州布拖县HIV感染者100例和未知感染状态的体检者200例,同时采集受试者口腔黏膜渗出液、尿液及血液标本。使用2种HIV-1/2抗体口腔黏膜渗出液检测试剂(评价试剂A、B)和1种酶联免疫吸附法尿液HIV-1/2抗体检测试剂(评价试剂C)对相应标本进行检测,同时使用丽珠HIV抗体酶联免疫法检测试剂(对比试剂)检测上述人群的血浆标本,再将评价试剂与对比试剂检测结果进行比较。结果评价试剂A、B、C阳性符合率分别为98.21%、90.82%、97.32%[95%可信区间(95%CI):93.06～99.69、82.84～95.45、91.79～99.31],阴性符合率分别为98.81%、96.24%、95.29%(95%CI:95.32～99.79、91.00～98.61、90.61～97.80),总符合率分别为98.57%、93.94%、96.10%(95%CI:96.13～99.54、89.82～96.52、92.93～97.94)。3种评价试剂与对比试剂一致性较好(κ=0.970、0.875、0.919)。3种评价试剂检测HIV抗体的受试者工作特征曲线下面积分别为0.991、0.935、0.975(95%CI:0.977～1.000、0.897～0.973、0.951～0.998)。结论 3种评价试剂与对比试剂的符合率较高,一致性较好,且无创检测样本采集方便,危险性小,在医疗条件有限、采血困难人群及具有特殊风俗习惯的少数民族地区可考虑推广应用口腔黏膜渗出液或者尿液无创检测试剂进行HIV抗体初筛检测。
Objective Taking Yi people of Liangshan Prefecture as the research objects,to evaluated the detection performance of three kinds of human immunodeficiency virus(HIV)antibody noninvasive(oral mucosal transudate fluid and urine)detection reagents.Methods Totally 100 HIV infectors and 200 healthy controls with unknown infectious condition in Butuo county of Liangshan Prefecture were enrolled from October2017 to March 2018,and the oral mucosal transudate fluid,urine and blood samples of the subjects were collected.Two kinds of oral mucosal exudate HIV 1/2 antibody detection reagent(A and B evaluation reagent)and enzyme-linked immunosorbent method urine HIV-1 1/2 antibody detection reagent evaluation reagent(C)were used to test the corresponding specimens,and the plasma samples of the above subjects were detected by Livzon HIV antibody enzyme-linked immunosorbent assay reagent(comparative reagent)at the same time,then the comparative reagent and the comparative reagent were compared.Results The positive coincident rate of the evaluation reagents A,B and C were 98.21%(95%CI 93.06-99.69),90.82%(95%CI 82.84-95.45)and 97.32%(95%CI 91.79-99.31)respectively,the negative coincidence rates were 98.81%(95%CI 95.32-99.79),96.24%(95%CI 91.00-98.61),95.29%(95%CI 90.61-97.80)respectively,the total coincidence rates were 98.57%(95%CI 96.13-99.54),93.94%(95%CI 89.82-96.52),96.10%(95%CI92.93-97.94)respectively.The three evaluation reagents were in good agreement with the comparison reagents(κ=0.97,0.875,0.919).The area under the ROC curve of the three evaluation reagents for detecting HIV antibodies were 0.991(95%CI 0.977-1.000),0.935(95%CI 0.897-0.973)and 0.975(95%CI0.951-0.998).Conclusion Compared with the contrast agents,the three kinds of evaluation reagents are with higher coincidence rate and better consistence.Non-invasive test sample collection is convenient and safety.In areas with limited medical conditions,it may be considered to promote the application of oral mucosal exudate or urine non-invasive detection reagent for HIV antibody screening among people with difficulty in collecting blood and ethnic minority areas with special customs and habits.
Objective Taking Yi people of Liangshan Prefecture as the research objects,to evaluated the detection performance of three kinds of human immunodeficiency virus(HIV)antibody noninvasive(oral mucosal transudate fluid and urine)detection reagents.Methods Totally 100 HIV infectors and 200 healthy controls with unknown infectious condition in Butuo county of Liangshan Prefecture were enrolled from October2017 to March 2018,and the oral mucosal transudate fluid,urine and blood samples of the subjects were collected.Two kinds of oral mucosal exudate HIV 1/2 antibody detection reagent(A and B evaluation reagent)and enzyme-linked immunosorbent method urine HIV-1 1/2 antibody detection reagent evaluation reagent(C)were used to test the corresponding specimens,and the plasma samples of the above subjects were detected by Livzon HIV antibody enzyme-linked immunosorbent assay reagent(comparative reagent)at the same time,then the comparative reagent and the comparative reagent were compared.Results The positive coincident rate of the evaluation reagents A,B and C were 98.21%(95%CI 93.06-99.69),90.82%(95%CI 82.84-95.45)and 97.32%(95%CI 91.79-99.31)respectively,the negative coincidence rates were 98.81%(95%CI 95.32-99.79),96.24%(95%CI 91.00-98.61),95.29%(95%CI 90.61-97.80)respectively,the total coincidence rates were 98.57%(95%CI 96.13-99.54),93.94%(95%CI 89.82-96.52),96.10%(95%CI92.93-97.94)respectively.The three evaluation reagents were in good agreement with the comparison reagents(κ=0.97,0.875,0.919).The area under the ROC curve of the three evaluation reagents for detecting HIV antibodies were 0.991(95%CI 0.977-1.000),0.935(95%CI 0.897-0.973)and 0.975(95%CI0.951-0.998).Conclusion Compared with the contrast agents,the three kinds of evaluation reagents are with higher coincidence rate and better consistence.Non-invasive test sample collection is convenient and safety.In areas with limited medical conditions,it may be considered to promote the application of oral mucosal exudate or urine non-invasive detection reagent for HIV antibody screening among people with difficulty in collecting blood and ethnic minority areas with special customs and habits.
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.2017年11月全国艾滋病性病疫情[J].中国艾滋病性病,2018,24(1):1.
[2] Ruan Y H,Hong K X,Liu S Z,et al.Community-based survey of HCV and HIV coinfection in drug abusers in Sichuan province of China[J].World J Gastroenterol,2004,10(11):1589-1593.
[3]王菊,杨淑娟,王启兴,等.凉山彝族自治州2011-2015年艾滋病哨点吸毒人群HIV感染状况及影响因素[J].中国艾滋病性病,2017,23(12):1107-1110.
[4] HOLM-HANSEN C,CONSTANTINE N T,HANKENES G.Detection of antibodies to HIV in homologous sets of plasma,urine and oral mucosal transudate samples using rapid assays in Tanmnia[J].Clin Diagn Vrol,1993,1(4):207-214.
[5]戴建平,李庆华,覃绍莹,等.203名吸毒人员血液和尿液HIV抗体检测结果对比分析[J].中国艾滋病性病,2003,9(5):278-279.
[6]万卓越,周海,赵茜茜,等.人血液和尿液样本HIV-1抗体的ELISA检测比较[J].华南预防医学,2002,28(1);25-26.
[7] Li X,Lu H,Raymond H F,et al.Untested and undiagnosed:barriers to HIV testing among men who have sex with men.Beijing,China[J].Sex Transm Infect,2012,88(3):187-193.
[8]许瑜楠,齐啸,李东亮,等.北京市男男性行为者HIV唾液快检支付意愿调查[J].中国公共卫生,2013,29(12):1721-1725.
[9]中国疾病预防控制中心防艾中心.2017年全国艾滋病病毒抗体诊断试剂临床质量评估报告[DB/OL].[2018-12-20]. https://max. book118. com/html/2017/1112/139768423.shtm.
[10]周久顺,董彩婷,黄俊,等.彝族人群艾滋病流行病学调查的组织管理[J],预防医学情报杂志,2014,30(2):81-83.
[11]REYNOLDS S J,MUWONGA J.OraQuick ADVANCE Rapid HIV-1/2antibody test[J].Expert Rev Mol Diagn,2004,4(5):587-591.
[12]TAMASHIRO H,CONSTANTINE N T.Serological diagnosis of HIV infection using oral fluid samples[J].Bull World Health Organ,1994,72(1):135-143.
[13]李秀,陈莉霞,海美玲.尿液抗HIV-1抗体检测结果分析[J]中国实验诊断学,2015,19(8):1420.
[2] Ruan Y H,Hong K X,Liu S Z,et al.Community-based survey of HCV and HIV coinfection in drug abusers in Sichuan province of China[J].World J Gastroenterol,2004,10(11):1589-1593.
[3]王菊,杨淑娟,王启兴,等.凉山彝族自治州2011-2015年艾滋病哨点吸毒人群HIV感染状况及影响因素[J].中国艾滋病性病,2017,23(12):1107-1110.
[4] HOLM-HANSEN C,CONSTANTINE N T,HANKENES G.Detection of antibodies to HIV in homologous sets of plasma,urine and oral mucosal transudate samples using rapid assays in Tanmnia[J].Clin Diagn Vrol,1993,1(4):207-214.
[5]戴建平,李庆华,覃绍莹,等.203名吸毒人员血液和尿液HIV抗体检测结果对比分析[J].中国艾滋病性病,2003,9(5):278-279.
[6]万卓越,周海,赵茜茜,等.人血液和尿液样本HIV-1抗体的ELISA检测比较[J].华南预防医学,2002,28(1);25-26.
[7] Li X,Lu H,Raymond H F,et al.Untested and undiagnosed:barriers to HIV testing among men who have sex with men.Beijing,China[J].Sex Transm Infect,2012,88(3):187-193.
[8]许瑜楠,齐啸,李东亮,等.北京市男男性行为者HIV唾液快检支付意愿调查[J].中国公共卫生,2013,29(12):1721-1725.
[9]中国疾病预防控制中心防艾中心.2017年全国艾滋病病毒抗体诊断试剂临床质量评估报告[DB/OL].[2018-12-20]. https://max. book118. com/html/2017/1112/139768423.shtm.
[10]周久顺,董彩婷,黄俊,等.彝族人群艾滋病流行病学调查的组织管理[J],预防医学情报杂志,2014,30(2):81-83.
[11]REYNOLDS S J,MUWONGA J.OraQuick ADVANCE Rapid HIV-1/2antibody test[J].Expert Rev Mol Diagn,2004,4(5):587-591.
[12]TAMASHIRO H,CONSTANTINE N T.Serological diagnosis of HIV infection using oral fluid samples[J].Bull World Health Organ,1994,72(1):135-143.
[13]李秀,陈莉霞,海美玲.尿液抗HIV-1抗体检测结果分析[J]中国实验诊断学,2015,19(8):1420.
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