ECLIA与TP-ELISA在梅毒检测中的一致性比较

Consistent Comparison of ECLIA and TP-ELISA in Detection of Syphilis

目的探讨电化学发光免疫(ECLIA)分析法与梅毒螺旋体抗体酶联免疫吸附试验(TP-ELISA)在梅毒检测中的差异性及其各自的特点。方法收集重庆医科大学附属第三医院临床确诊的梅毒患者血清标本112例以及非梅毒患者血清标本1 000例。分别采用ECLIA法和TP-ELISA法对标本进行检测,计算两种方法的符合率并分析其差异。结果 ECLIA与TP-ELISA两种方法的阳性符合率为96.43%,阴性符合率为100%,两种方法具有一致性(κ=0.980,P<0.01)。结论 ECLIA法是一种敏感性、特异性和准确性都较高的检测梅毒抗体的方法,TP-ELISA法在S/CO<2.68时重复性低于ECLIA法,需要注意复检工作,以防止漏检造成的不必要的医疗纠纷。

Objective To investigate the differences between the Electrochemical luminescence immunoassay(ECLIA)and the TP-ELISA in the detection of syphilis and their characteristics. Methods Serum samples were collected from 112 patients with and 1000 without Syphilis in the Third Affiliated Hospital of CQMU. Both ECLIA and TPELISA methods were used to analyze the samples,the coincidence rate and the differences of the two methods were calculated and analyzed. Results The positive coincidence rate for the two methods was 96.43%,while the negative rate was 100%. There was intensive concordance between ECLIA and TP-ELISA(κ=0.980,P<0.01). Conclusions ECLIA is a method with high sensitivity,specificity and accuracy in syphilis antibody detections. The repeatability of TP-ELISA was lower than ECLIA when S/CO<2.68. The re-examination work should be pay more attention to in order to prevent unexpected medical disputes caused by false negative results.