化学发光免疫分析法与酶联免疫斑点试验诊断结核病的相关性研究

Correlation analysis of chemiluminescence assay and enzyme-linked immunospot assay for diagnosis of tuberculosis

目的通过分析化学发光免疫分析法(CLIA)与酶联免疫斑点试验(ELISPOT)检测γ-干扰素(IFN-γ)结果的相关性,探讨CLIA法诊断结核病的可行性。方法收集2018年8月7日—9月4日北京航天中心医院收治的28例疑诊结核病患者的血液标本,分别采用CLIA法和ELISPOT法对IFN-γ进行测定,同时以结核分枝杆菌(MTB)培养结果作为参照标准。采用Kappa相关性分析方法对CLIA法与ELISPOT法检测结果进行评价;绘制受试者工作特征曲线(ROC),分析两种方法诊断结核病的敏感度和特异度。结果相关性分析显示,两种方法检测IFN-γ的Kappa值为0.602;CLIA法诊断结核病的ROC曲线下面积(AUC)为0.875[95%可信区间(95%CI)=0.743~1.007],敏感度为100%,特异度为75%;ELISPOT法诊断结核病的AUC为0.750(95%CI=0.481~1.019),敏感度为75%,特异度为75%。结论 CLIA法与ELISPOT法检测IFN-γ的相关性尚可,CLIA法具有结果易于读取、容易进行高通量检测的特点,有一定的临床应用前景。

Objective Through analyzing two kinds of interferon gamma release assay（IGRA）： chemiluminescence assay（CLIA） and enzyme-linked immunospot assay（ELISPOT） to detect the correlation of the results of γ-interferon（IFN-γ） and approach the feasibility of using CLIA for the diagnosis of tuberculosis. Methods From August 7 to September 4, 2018, the blood samples of 28 patients with suspected tuberculosis were collected in Beijing Aerospace Central Hospital, their blood levels of IFN-γ were determined by CLIA and ELISPOT assays respectively, and in the mean time the Mycobacterium tuberculosis（MTB） cultures were performed to be the reference standards. The Kappa correlation analysis was used to evaluate the results of CLIA and ELISPOT assay： the receiver working characteristic（ROC） curve was plotted to determine the sensitivity and specificity of the two methods for diagnosis of tuberculosis. Results The correlation analysis showed： the Kappa value of the two methods（CLIA and ELISPOT） detecting IFN-γ was 0.602; the AUC（ROC） of CLIA method in diagnosis of TB was 0.875 [95% confidence interval（95%CI） = 0.743-1.007], the sensitivity and specificity were 100% and 75%, respectively; the AUC of ELISPOT assay in diagnosis of TB was 0.750（95%CI = 0.481-1.019）, the sensitivity and specificity were 75% and 75%, respectively. Conclusion The correlation of using CLIA and ELISPOT methods for detection of IFN-γ in patients with TB is available. It is easy to read and obtain the results of CLIA detection of IFN-γ and to carry out high-flux determination, so that CLIA has a certain application value in clinical prospects.