两种进口化学发光系统筛查HIV的灵敏度比较  

The Sensitivity Comparison of Two Imported Chemiluminescence Systems for HIV Screening

作　　者：袁晓华 左芳[2] 袁科[3] 高珊 汪宏良 YUAN Xiao-hua;ZUO Fang;YUAN Ke;GAO Shan;WANG Hong-liang(School of Medicine,Wuhan University of Science and Technology,Wuhan 430062,China;Transfusion Department,Huangshi Central Hospital,Huangshi 435000,China;Clinical Laboratory,Huangshi Central Hospital,Huangshi 435000,China)

机构地区：[1]武汉科技大学医学院,湖北武汉430062 [2]黄石市中心医院输血科,湖北黄石435000 [3]黄石市中心医院检验科,湖北黄石435000

出　　处：《标记免疫分析与临床》2019年第12期2141-2144,共4页Labeled Immunoassays and Clinical Medicine

摘　　要：目的对两种进口化学发光检测系统筛查HIV的灵敏度进行比较。方法用一种电化学发光试剂(ECLIA试剂)和一种化学发光试剂(CLIA试剂)各自筛查临床样本,ECLIA法从57265例样本中筛查出阳性229例,CLIA法从32541例样本中筛查出阳性65例。把这229例样本用CLIA法检测,65例样本用ECLIA法检测。全部294例样本送疾控中心进行Western blot(WB)确认试验。结果(1)ECLIA法阳性的229例,用CLIA法复检阳性155例,WB法确认阳性113例,不确定6例;CLIA法阳性的65例,用ECLIA法复检阳性64例,WB法确认阳性48例,不确定0例。(2)ECLIA法6例阳性而WB法不确定的样本,其中3例随访成功,1例转阳。结论ECLIA法的假阳性率高于CLIA法,同时ECLIA法的灵敏度高于CLIA法,虽然筛查方法的高灵敏度会导致送检确认的样本增多,提高了社会成本,但是能检测HIV-1 p24抗原的第4代化学发光法能缩短检测“窗口期”,更早的筛查出HIV阳性样本。Objective To compare the sensitivity of two imported chemiluminescence detection systems for HIV screening.Methods Clinical samples were screened by one electrochemiluminescent reagent(ECLIA reagent)and one chemiluminescent reagent(CLIA reagent).229 of 57,265 samples were positive by ECLIA method,and 65 of 32,541 samples were positive by CLIA method.The identified 229 samples were then detected by CLIA and 65 samples were detected by ECLIA.All 294 samples were sent to CDC for western blot(WB)confirmation test.Results(1)Among 229 cases of ECLIA positive:CLIA positive for 155 cases,WB positive for 113 cases,uncertain for 6 cases;Among 65 cases of CLIA positive:ECLIA positive for 64 cases,WB positive for 48 cases,uncertain for 0 cases.(2)Among six ECLIA positive and WB uncertain samples,3 were followed up successfully and 1 was positive.Conclusion The false positive rate of ECLIA method is higher than CLIA method,and the sensitivity of ECLIA method is higher than CLIA method.Although the high sensitivity of screening method will increase the number of confirmed samples and increase the social cost,the fourth generation chemiluminescence method,which can detect HIV-1 p24 antigen,can shorten the detection window period and screen HIV-positive samples earlier.

关 键 词：人类免疫缺陷病毒 血液筛查 化学发光 电化学发光 

分 类 号：R44[医药卫生—诊断学]