尿液HIV抗体胶体金检测方法性能评价  

Performance evaluation of urine HIV antibody colloidal gold assay

作　　者：王月华[1] 程焕义 王继宝[2] 陈凯 赫晓霞[1] 段星[2] 叶润华[2] 段松[2] 蒋岩[1] WANG Yuehua;CHENG Huanyi;WANG Jibao;CHEN Kai;HE Xiaoxia;DUAN Xing;YE Runhua;DUAN Song;JIANG Yan(National Center for AIDS/STD Control and Prevention,Chinese Center for Disease Control and Prevention,Beijing 102206,China;Dehong Center for Disease Control and Prevention,Dehong 650034,Yunnan)

机构地区：[1]中国疾病预防控制中心性病艾滋病预防控制中心中心参比实验室,北京102206 [2]云南省德宏州疾病预防控制中心,云南德宏650034

出　　处：《中国艾滋病性病》2019年第7期668-670,686,共4页Chinese Journal of Aids & STD

基　　金：国家“十三五”重大专项研究课题(2018ZX10732101-001-010)~~

摘　　要：目的对国家"十三五"重大专项课题研发的2个尿液艾滋病病毒(HIV)抗体检测试剂(胶体金法)的检测性能进行临床试验前评价。方法用HIV1/2抗体尿液国家参考品对胶体金法HIV尿液抗体检测试剂进行检验评估;用541份未接受抗病毒治疗(ART)、72份接受ART的HIV抗体确证阳性者、214份HIV抗体阴性者尿液样本,以酶联免疫吸附试验(ELISA)尿液HIV抗体检测试剂作为对照,比较两种方法的敏感性与特异性及ART对胶体金法尿液HIV抗体检测结果的影响。结果 HIV1/2抗体尿液国家参考品检测结果显示,两个胶体金法HIV尿液抗体检测试剂能达到该参考品检测要求;未进行ART的541份样本中,两个尿液胶体金法与ELISA法HIV抗体检测试剂敏感性分别为98.52%(533例),97.04%(525例)与98.89%(535例),特异性均为100%。两个尿液胶体金检测结果与尿液ELISA检测结果相比、尿液HIV抗体检测结果与血液HIV抗体检测结果相比,差异均无统计学意义(P>0.05)。72例ART病人样本,两个胶体金法与ELISA法尿液HIV抗体检测试剂的检测敏感性分别为58.33%(42例),52.78%(38例)与70.83%(51例),经卡方检验两个尿液胶体金法与ELISA法敏感性差异无统计学意义(P>0.05),尿液胶体金法与ELISA法HIV抗体检测结果与血液HIV抗体检测结果差异有统计学意义(P<0.05)。结论胶体金法尿液HIV抗体检测试剂盒的敏感性与特异性与已经上市的ELISA没有差别,可用于高危人群HIV筛查,接受ART的HIV感染者/艾滋病病人不适用尿液抗体检测。Objective To have pre-clinical performance evaluation of two urine human immunodeficiency virus antibodies test kits(colloidal gold method). Methods The "national reference panel for antibodies to human immune-deficiency virus in human urine" was used for this laboratory assessment of urine HIV antibody test reagents. The sensitivity, specificity and consistency of the two kits were compared with the 541 clinically HIV antibody(WB confirmed) positive without antiviral therapy(ART), 214 HIV-negative specimens, and 72 HIV antibodies(WB confirmed) positive with ART, to evaluate the effect of performance of the urine HIV antibody detection reagents of colloidal gold method and ELISA method. Results The result of evaluation of urine HIV antibody test reagents showed that it was compliant with the requirements of the "national reference panel for antibodies to human immune-deficiency virus in human urine". The sensitivity of the colloidal gold method and the ELISA method for detection of urine HIV antibodies was 98.52%(533), 97.04%(525)and 98.89%(535) respectively, and the specificity was 100%. The sensitivity and specificity of the urine HIV antibodies test kits were not statistically significant compared with the results of blood HIV antibody detection(P>0.05). The sensitivity of urine HIV antibody test reagents of two methods to ART samples was 58.33%(42), 52.78%(38) and 70.83%(51)respectively. The sensitivity of two methods was not significantly different(P>0.05). The sensitivity of the urine HIV antibodies test reagents was statistically significant compared with that of blood HIV antibody detection(P<0.05). Conclusion The sensitivity and specificity of the colloidal gold urine HIV antibody detection reagents are not different from the ELISA approved by CFDA. It can be used for HIV screening in high-risk groups after clinical trials. Urine HIV antibody detection reagents are not applicable to AIDS patients with antiviral treatment.

关 键 词：艾滋病病毒 尿液 抗体检测 胶体金法 

分 类 号：R512.91[医药卫生—内科学] R373.9[医药卫生—临床医学]