时间分辨荧光免疫法检测脑脊液结核分枝杆菌特异性抗原的诊断价值

Detection of Specific Antigen of Mycobacterium Tuberculosis in Cere-brospinal Fluid by Time-resolved Fluoroimmunoassay and Its Diagnostic Value

目的对时间分辨荧光免疫法检测脑脊液结核分枝杆菌特异性抗原的诊断价值进行研究。方法整群选取2012年6月—2013年6月于该院确诊为结核性脑膜炎患者48例,收集患者的脑脊液,建立时间分辨荧光免疫分析法检测脑脊液中ESAT-6-CFP10抗原。同时采用TRIFA法和ELISA法对结核性脑膜炎患者脑脊液检查特异度进行检测。结果 ESAT6/CFP10的TRIFA法稳定性好,线性宽,其检测灵敏度为2.5 ng/m L,平均回收率为97.6%,批内变异系数平均为3.35%,批间CV平均为5.32%。TRFIA法结核性脑膜炎患者脑脊液检查特异度为92.6%,明显高于ELISA法的82.4%,差异有统计学意义(P<0.05,χ2=5.5311)。结论 TRFIA法敏感度、精密度、重复性、线性相关性较好,检测脑脊液中ESAT-6-CFP10抗原对诊断结核性脑膜炎有很高的敏感度和特异度。

Objective To investigate the application of the time-resolved fluoroimmunoassay（TRIFA） in detecting the specific antigen of mycobacterium tuberculosis in cerebrospinal fluid and evaluate its diagnostic value. Methods The ESAT6/CFP10 antigen in the cerebrospinal fluid of 48 patients who were confirmed with tuberculous meningitis in our hospital during June 2012 and June 2013 were detected by time-resolved fluoroimmunoassay. For the diagnosis of tuberculous meningitis, the specificity of TRIFA in detecting the specific antigen of mycobacterium tuberculosis and that of the ELISA was compared. Results In detecting ESAT6/CFP10 antigen, TRIFA was stable and wide in linearity range, and its sensitivity, the mean recovery rate, the within-run and interday-run coefficients of variation were 2.5 ng/mL, 97.6%, 3.35%, 5.32%, respectively. The specificity of TRIFA in detecting the specific antigen of mycobacterium tuberculosis was 92.6%, obviously higher that of ELISA, 82.4%, and the difference was statistically significant（P〈0.05, χ^2=5.5311）. Conclusion With good sensitivity, precision, repeatability and linear correlation, TRFIA applied in the detection of ESAT6/CFP10 antigen in the cerebrospinal fluid has high sensitivity and specificity for the diagno-sis of tuberculous meningitis.