目的:比较市售的三种HIV抗体试剂盒检测HIV感染的能力,为HIV感染的早期发现提供参考方法。方法:分别采用两种第4代HIV试剂盒(英国Abbott公司生产的Murex HIV Ag/Ab检测试剂:编号为A;荷兰Organon公司Vironostika HIV Uni-FormⅡAg/Ab检...目的:比较市售的三种HIV抗体试剂盒检测HIV感染的能力,为HIV感染的早期发现提供参考方法。方法:分别采用两种第4代HIV试剂盒(英国Abbott公司生产的Murex HIV Ag/Ab检测试剂:编号为A;荷兰Organon公司Vironostika HIV Uni-FormⅡAg/Ab检测试剂:编号为B);一种第3代HIV试剂盒(英国Abbott公司生产的Murex HIV-1.2.O试剂:编号为C)及P24抗原(ELISA法)检测盒对3 863份血液样本及BBI阳转血清盘进行检测,对两种第4代HIV试剂盒检测的敏感性、特异性进行分析,同时分析三种抗体检测试剂盒对HIV感染窗口期检出的时间是否提前。结果:试剂盒A、B均完全检出54例HIV感染阳性的血液样本,试剂A检出的灵敏度=100%,特异度=99.61%,漏诊率=0,误诊率=0.39%;试剂B检出的灵敏度=100%,特异度=99.37%,漏诊率=0,误诊率=0.63%;试剂A和试剂B检出结果进行比较,结果差异不显著(P>0.05);A试剂、B试剂分别较C试剂的检测窗口期提前5.5和3.7 d,但与P24抗原试剂盒的检出窗口期比较却滞后4.25至6.05 d。结论:本研究中的两种第四代HIV抗体试剂盒检测HIV感染的能力较强,灵敏度均达到100%,同时能够将HIV感染检出的窗口期提前,有利于保证用血安全。展开更多
目的:评价BioMerieux公司的HIV抗原/抗体联合检测快速法(VIDAS HIV DUO QUICK)和Vironostika HIV Uniform II Ag-Ab ELISA法检测HIV抗体和P24抗原的特异性及敏感性。方法:用上述两种试剂分别检测HIV抗体阴性样品1184例、HIV抗体阳性样品...目的:评价BioMerieux公司的HIV抗原/抗体联合检测快速法(VIDAS HIV DUO QUICK)和Vironostika HIV Uniform II Ag-Ab ELISA法检测HIV抗体和P24抗原的特异性及敏感性。方法:用上述两种试剂分别检测HIV抗体阴性样品1184例、HIV抗体阳性样品128例、BBI阳转血清盘(PRB929 01-07)和7种不同稀释度的P24抗原阳性对照血清等,对其进行敏感性和特异性分析。结果:两种试剂检测HIV抗体均具有较高特异性,但快速法检测特异性较高(为98.6%),而ELISA法检测特异性较低(为96.0%)。两种试剂检测HIV抗体和抗原的敏感性一样。另外,从检测BBI阳转血清盘的结果可知,两种4代抗原/抗体联合检测试剂检测BBI阳转血清盘AD第18 d结果即为阳性,而3代HIV抗体检测试剂在第21 d结果为阳性,4代检测试剂敏感性比3代检测试剂高,进一步缩短了HIV感染检测的窗口期,可以检出窗口期的样品。结论:这2种4代检测试剂在增加HIV P24抗原检测的情况下,不影响其检测HIV抗体的特异性和敏感性,并进一步缩短了HIV感染窗口期。建议HIV抗体初筛检测使用第4代HIV抗原/抗体联合检测试剂,可检出更多艾滋病早期感染者。展开更多
Objective To develop a rapid,highly sensitive quantitative method for detecting P24 antigen based on near-infrared fluorescent microsphere immunochromatography.Methods First,we prepared a lateral flow assay test strip...Objective To develop a rapid,highly sensitive quantitative method for detecting P24 antigen based on near-infrared fluorescent microsphere immunochromatography.Methods First,we prepared a lateral flow assay test strip,and labeled the detection antibody using a fluorescent microsphere.Second,we optimized the antibody labeling conditions.Third,we optimized the detection conditions.Fourth,we created a working curve.Fifth,we conducted a methodological assessment of the established fluorescent microsphere immunochromatography method.Sixty-six clinical samples were tested,and we compared the established fluorescent microsphere immunochromatography with the quantitative ELISA method.Results According to the working curve,the detection limit of the method is 3.4 pg/mL,and the detection range is 3.4 pg/mL to 10 ng/mL.The average intra-assay recovery was 99.6%,and the Coefficient of Variation(CV)was 5.4%–8.6%;the average inter-assay recovery was 97.3%,and the CV was 8.5%–11%.The detection rate of fluorescent microsphere immunochromatography was higher than ELISA method,and had a good correlation with ELISA.Conclusion The P24 antigen quantitative detection method based on near-infrared fluorescent microsphere immunochromatography has the advantages of rapid detection,high sensitivity,and wide detection range;thus,it is suitable for early clinical diagnosis and continuous monitoring of AIDS.展开更多
文摘目的:比较市售的三种HIV抗体试剂盒检测HIV感染的能力,为HIV感染的早期发现提供参考方法。方法:分别采用两种第4代HIV试剂盒(英国Abbott公司生产的Murex HIV Ag/Ab检测试剂:编号为A;荷兰Organon公司Vironostika HIV Uni-FormⅡAg/Ab检测试剂:编号为B);一种第3代HIV试剂盒(英国Abbott公司生产的Murex HIV-1.2.O试剂:编号为C)及P24抗原(ELISA法)检测盒对3 863份血液样本及BBI阳转血清盘进行检测,对两种第4代HIV试剂盒检测的敏感性、特异性进行分析,同时分析三种抗体检测试剂盒对HIV感染窗口期检出的时间是否提前。结果:试剂盒A、B均完全检出54例HIV感染阳性的血液样本,试剂A检出的灵敏度=100%,特异度=99.61%,漏诊率=0,误诊率=0.39%;试剂B检出的灵敏度=100%,特异度=99.37%,漏诊率=0,误诊率=0.63%;试剂A和试剂B检出结果进行比较,结果差异不显著(P>0.05);A试剂、B试剂分别较C试剂的检测窗口期提前5.5和3.7 d,但与P24抗原试剂盒的检出窗口期比较却滞后4.25至6.05 d。结论:本研究中的两种第四代HIV抗体试剂盒检测HIV感染的能力较强,灵敏度均达到100%,同时能够将HIV感染检出的窗口期提前,有利于保证用血安全。
文摘目的:评价BioMerieux公司的HIV抗原/抗体联合检测快速法(VIDAS HIV DUO QUICK)和Vironostika HIV Uniform II Ag-Ab ELISA法检测HIV抗体和P24抗原的特异性及敏感性。方法:用上述两种试剂分别检测HIV抗体阴性样品1184例、HIV抗体阳性样品128例、BBI阳转血清盘(PRB929 01-07)和7种不同稀释度的P24抗原阳性对照血清等,对其进行敏感性和特异性分析。结果:两种试剂检测HIV抗体均具有较高特异性,但快速法检测特异性较高(为98.6%),而ELISA法检测特异性较低(为96.0%)。两种试剂检测HIV抗体和抗原的敏感性一样。另外,从检测BBI阳转血清盘的结果可知,两种4代抗原/抗体联合检测试剂检测BBI阳转血清盘AD第18 d结果即为阳性,而3代HIV抗体检测试剂在第21 d结果为阳性,4代检测试剂敏感性比3代检测试剂高,进一步缩短了HIV感染检测的窗口期,可以检出窗口期的样品。结论:这2种4代检测试剂在增加HIV P24抗原检测的情况下,不影响其检测HIV抗体的特异性和敏感性,并进一步缩短了HIV感染窗口期。建议HIV抗体初筛检测使用第4代HIV抗原/抗体联合检测试剂,可检出更多艾滋病早期感染者。
基金supported by the National Natural Science Foundation of China[no.21677006]National Key Research and Development Project[2017YFC1200500].
文摘Objective To develop a rapid,highly sensitive quantitative method for detecting P24 antigen based on near-infrared fluorescent microsphere immunochromatography.Methods First,we prepared a lateral flow assay test strip,and labeled the detection antibody using a fluorescent microsphere.Second,we optimized the antibody labeling conditions.Third,we optimized the detection conditions.Fourth,we created a working curve.Fifth,we conducted a methodological assessment of the established fluorescent microsphere immunochromatography method.Sixty-six clinical samples were tested,and we compared the established fluorescent microsphere immunochromatography with the quantitative ELISA method.Results According to the working curve,the detection limit of the method is 3.4 pg/mL,and the detection range is 3.4 pg/mL to 10 ng/mL.The average intra-assay recovery was 99.6%,and the Coefficient of Variation(CV)was 5.4%–8.6%;the average inter-assay recovery was 97.3%,and the CV was 8.5%–11%.The detection rate of fluorescent microsphere immunochromatography was higher than ELISA method,and had a good correlation with ELISA.Conclusion The P24 antigen quantitative detection method based on near-infrared fluorescent microsphere immunochromatography has the advantages of rapid detection,high sensitivity,and wide detection range;thus,it is suitable for early clinical diagnosis and continuous monitoring of AIDS.
