第四代电化学发光HIV筛查试剂在AIDS诊断中的应用探讨  

Value of the Fourth Generation Electrochemiluminescence HIV Screening Reagent in the Diagnosis of Acquired Immunodeficiency Syndrome(AIDS)

作　　者：方欢英[1] 郭金虎[1] 姜鹏飞 杨术生[1] FANG Huanying;GUO Jinhu;JIANG Pengfei;YANG Shusheng(Department of Laboratory Medcine,Shanghai East Hospital,Tongji University School of Medicine,Shanghai 200123,China)

机构地区：[1]同济大学附属东方医院检验科,上海200123

出　　处：《中国皮肤性病学杂志》2020年第8期959-963,共5页The Chinese Journal of Dermatovenereology

基　　金：上海市浦东新区卫生系统重点学科建设资助(PWZxk2017-09)。

摘　　要：目的对比人类免疫缺陷病毒(HIV)抗体第四代电化学发光免疫分析(ECLIA)试剂筛查结果与免疫印迹试验(WB)结果,评估ECLIA法HIV筛查在艾滋病诊断中的临床价值。方法ECLIA法对2016年1月-2019年8月本院109649例患者进行HIV抗体初筛检测,复核阳性标本用WB法确证,记录结果并进行对比分析。结果ECLIA法初筛阳性217例,WB确证阳性45例,ECLIA初筛方法确证阳性率为20.74%。WB确证阳性患者ECLIA法S/CO值为367.70(160.60,790.80),与确证阴性患者S/CO值[2.1(1.45,3.96)]和确证不确定患者S/CO值[1.84(1.31,3.83)]差异有统计学意义(P<0.05)。比较1<S/CO≤10、10<S/CO≤50及S/CO>50三组,WB法获得的阳性率的差异有统计学意义(P<0.05)。结论ECLIA法筛查HIV抗体灵敏度较高,但存在较高的假阳性率,尤其是低S/CO值的标本。较高的S/CO值的患者HIV感染的风险较大,但是高S/CO值并不代表HIV感染,应进一步推进诊断试剂的研发和改进进程,助力临床精准医疗,减轻AIDS公共管理负担。Objective To evaluate the clinical value of human immunodeficiency virus(HIV)antibody screening in the diagnosis of acquired immunodeficiency syndrome(AIDS)by comparing the fourth generation electrochemiluminescence immunoassay(ECLIA)results with those from Western blot(WB).Methods The 109649 patients in our hospital from January 2016 to August 2019 were examined for HIV antibody by the fourth generation ECLIA method.The re-inspection of positive samples was confirmed by WB,the results were recorded and analyzed.Results There were 217 HIV-antibody preliminary screening positive samples totally,45 cases of which were confirmed positive by WB.The positive rate of ECLIA screening method was 20.74%.The S/CO value of ECLIA in WB positive patients was 367.70(160.60,790.80),which was significantly different from that of negative patients[2.1(1.45,3.96)]and uncertain patients[1.84(1.31,3.83)](P<0.05).The confirmed positive rate was statistically significant among 1<S/CO≤10,10<S/CO≤50 and S/CO>50 groups(P<0.05).Conclusion ECLIA for HIV-antibody screening has a high sensitivity,while the false positive rate is also high,especially in low S/CO value samples.Patients with higher S/CO value have a higher risk of HIV infection,but high S/CO value does not represent HIV infection.Therefore the diagnostic reagent development and improvement should be further accelerated to help clinically precise treatment and reduce the burden of AIDS in public health management.

关 键 词：人类免疫缺陷病毒 电化学发光免疫分析 免疫印迹试验 

分 类 号：R512.91[医药卫生—内科学]