电化学发光免疫法与酶联免疫法在梅毒诊断中的价值分析

The Value of Electrochemiluminescence Immunoassay and Enzyme-linked Immunosorbent Assay in the Diagnosis of Syphilis

目的对比探讨电化学发光免疫分析法(ECLIA法)和酶联免疫法(ELISA法)用于梅毒诊断的灵敏度和准确性。方法选择83例2018年12月—2019年6月该院进行梅毒抗体ECLIA法检测诊断的弱阳性标本(发光值在1-10 COI))和临界值标本(发光值接近1COI),再用ELISA法进行检测,以对比两种检测方法的灵敏度、准确度、特异度、阳性/阴性预测值;最后用TPPA确诊试验检测。结果TPPA确诊试验检测阳性73例,阴性10例,ECLIA法准确度为93.98%,灵敏度为100.00%,特异度为50.00%,阳性预测值为93.59%,阴性预测值为100.00%;ELISA法准确度为90.36%,灵敏度90.41%,特异度为90.00%,阳性预测值98.50%,阴性预测值56.25%;ECLIA法的准确度(χ^2=4.751,P=0.039)、灵敏度(χ^2=5.402,P=0.020)、阴性预测值(χ^2=4.608,P=0.021)均高于ELISA法。结论ECLIA法与ELISA法用于梅毒诊断均有非常高的灵敏度、准确度,用于临床梅毒早期筛查和诊断具有显著的价值,ECLIA法的灵敏度高于ELISA法,可用于弱阳性样本的检测,避免出现ELISA法假阴性而漏诊。

Objective To compare the sensitivity and accuracy of electrochemiluminescence immunoassay(ECLIA)and enzyme-linked immunosorbent assay(ELISA)for the diagnosis of syphilis.Methods 83 cases of weakly positive specimens(luminescence values of 1-10 COI)and critical specimens(luminescence values close to 1 COI)were selected from 83 patients from December 2018 to June 2019 in the hospital for serotonin antibody ECLIA and then the ELISA method was used,to compare the sensitivity,accuracy,specificity,and positive/negative prediction values of the two methods;finally,the TPPA was used to confirm the test.Results 73 cases were positive by TPPA,and 10 cases were negative.The accuracy of ECLIA was 93.98%,the sensitivity was 100.00%,the specificity was 50.00%,the positive predictive value was 93.59%,and the negative predictive value was 100.00%.The ELISA method of accuracy 90.36%,the sensitivity was 90.41%,the specificity was 90.00%,the positive predictive value was 98.50%,the negative predictive value was 56.25%;the ECLIA method was accurate(χ^2=4.751,P=0.039),sensitivity(χ^2=5.402,P=0.020);the negative predictive value(χ^2=4.608,P=0.021)was higher than the ELISA method.Conclusion ECLIA method and ELISA method have very high sensitivity and accuracy for syphilis diagnosis.They are of great value for early screening and diagnosis of clinical syphilis.The sensitivity of ECLIA method is higher than ELISA method,and it can be used for weak positive samples detection,to avoid false negative ELISA and missed diagnosis.