电化学发光免疫分析和酶联免疫吸附试验检测甲型肝炎病毒IgM抗体的比较  

Effects of Electrochemiluminescence Immunoassay and Enzyme- linked Immunosorbent Assay for Detection of Hepatitis A Virus IgM Antibody: a Comparative Study

作　　者：黄妩姣[1] 薛元霞[1] 杨佩桦[2] 黄惠[1] 涂晓欣 

机构地区：[1]广东省中医院,广东广州510120 [2]广州医科大学金域检验学院,广东广州510182

出　　处：《现代医院》2016年第3期383-385,共3页Modern Hospitals

基　　金：广东省科技计划项目(编号:2014A020212270)

摘　　要：目的比较和评价电化学发光免疫分析法(ECLIA)和酶联免疫吸附试验(ELISA)测定甲型肝炎病毒(HAV)抗体IgM。方法选择本院住院或门诊患者血清共116例,均使用ECLIA和ELISA检测HAV-IgM抗体,对两种方法的一致性和临床诊断效能进行比较分析。结果用ECLIA和ELISA方法同时检测116例血清标本的HAV-IgM抗体,两种方法的阳性符合率为12.8%,阴性符合率为100%,总符合率为70.7%,两种方法的检测结果有统计学差异(P<0.05)。对两种方法检测结果不一致的34例患者进一步跟踪和随访,以临床诊断为标准,ECLIA检测HAV-IgM的敏感度、特异性、阳性检出率分别是:62.5%、100.0%、4.3%;ELISA方法的敏感度、特异性、阳性检出率分别是:100.0%、71.3%和33.6%。结论 ECLIA和ELISA对HAV-Ig M抗体检测结果的一致性较低,ELISA方法敏感度高,但ECLIA特异性好,检测过程可全自动化,检验结果更符合临床,可引入实验室检测,为临床甲型肝炎病毒感染提供诊断依据。Objective To compare and evaluate the effects of electrochemiluminescence immunoassay（ECLIA） and enzyme -linked immunosorbent assay（ELISA） for determination of hepatitis A Virus （HAV） IgM antibody. Methods 116 patients were selected for detection of HAV - IgM antibody by ECLIA and ELISA at the same time, and then the consistency and clinical diagnostic efficiency of these two methods were compared. Results The HAV - IgM antibody of the serum sam- ples detected by ECLIA and ELISA showed that the positive coincidence rate of two methods was 12. 8%, the negative coinci- dence rate 100% , the total coincidence rate 70. 7%. Results of two methods were statistically different （P 〈 0. 05）. The fol- low - ups for the 34 patients with the methods were inconsistent. Based on clinical diagnosis as a gold standard, the sensitivi- ty, specificity and total positive rate of ECLIA were 62. 5% , 100. 0% and 4. 3% , respectively. Those by EL1SA were 100. 0%, 71.3% and 33.6%, respectively. Conclusion The consistency of HAV- IgM antibody detection results with ECLIA and ELISA is low. ELISA has a good sensitivity, while ECLIA has a better specificity and detection process of ECL1A can be automated and it＇s more consistent with clinical results. Therefore, ECLIA can be introduced for clinical laboratory to provide clinical diagnosis for HAV infection.

关 键 词：甲型肝炎病毒IgM抗体 电化学发光免疫分析法 酶联免疫吸附试验 

分 类 号：R446.112[医药卫生—诊断学] R512.61[医药卫生—临床医学]