电化学发光法、化学发光法与酶联免疫吸附试验检测梅毒抗体效果对比分析

Comparative analysis of the effects of Electrochemiluminescence(ECLIA),Chemiluminescence(CLIA)and Enzyme-linked immunosorbent assay(ELISA)on the detection of syphilis antibodies

目的利用电化学发光法(Electrochemiluminescence,ECLIA)、化学发光法(Chemiluminescence,CLIA)和酶联免疫吸附试验(Enzyme-linked immunosorbent assay,ELISA)对梅毒抗体进行检测,对比分析三种方法的检测效果,以便选择出最合适大批量样本的筛查方法。方法选取安徽医科大学第一附属医院检验科于2018年1月~2019年2月间接收的2237例无偿献血者的血浆样本为研究对象,所有样本采用ECLIA、CLIA和ELISA三种方法进行检测,对其检测结果的敏感性和特异性进行分析比较。结果2237份样本中ECLIA确认阳性47例、CLIA确认阳性49例、ELISA确认阳性53例,灵敏度分别为97.92%、96.08%、94.64%,特异性分别为99.68%、99.67%、97.48%,ECLIA和CLIA的灵敏度和特异性显著高于ELISA,差异有统计学意义(灵敏度:0.032、0.015,特异性:0.011、0.043),ECLIA的灵敏度和特异性略高于CLIA,但差异无统计学意义(灵敏度:0.947,特异性:0.998);随着ELISA阳性检测结果S/CO值的增大,ELISA与ECLIA和CLIA的阳性符合率和阳性滴度也随之升高,但ECLIA的阳性符合率较CLIA高,且ECLIA的假阳性率较CLIA低。结论ECLIA具有较高的灵敏度和特异性,适合对无偿献血样本进行大规模筛查,对于S/CO值低的样本可结合CLIA或ELISA进行再确证。

Objective To detect the syphilis antibodies with the use of Electrochemiluminescence(ECLIA),Chemiluminescence(CLIA)and Enzyme-linked immunosorbent assay(ELISA),and compare the tests results of these three method so as to select the most suitable screening method for large quantities of samples.Methods Totally 2237 plasma samples from unpaid donors were selected as the research object by the Clinical Laboratory of the First Affiliated Hospital of Anhui Medical University from January 2018 to February 2019.All samples were detected by ECLIA,CLIA and ELISA,and the sensitivity and specificity of the detection results were analyzed and compared.Results The 47 cases of total 2237 plasma samples were confirmed positive by ECLIA,with 49 samples confirmed positive by CLIA and 52 cases confirmed positive by ECLIA.Their sensitivity were 97.92%,96.08%and 94.64%,respectively.And the specificity of them were 99.68%,99.67%,97.48%,respectively.The sensitivity and specificity of ECLIA and CLIA were greatly higher than those of ELISA,the difference was statistically significant(sensitivity:0.032,0.015;specificity:0.011,0.043).The sensitivity and specificity of ECLIA were higher than those of CLIA,and the difference was not statistically significant(sensitivity:0.947;specificity:0.998).With the increase of S/CO value of ELISA positive test result,the positive coincidence rate and positive titer of ELISA,ECLIA and CLIA also increased.However,compared with CLIA,the positive coincidence rate of ECLIA was higher and its false positive rate was lower.Conclusion ECLIA has higher sensitivity and specificity,so it is suitable for large-scale screening of blood samples from unpaid donors.For samples with low S/CO value,they can be reconfirmed by ECLIA combined with CLIA or ELISA.