CFP10蛋白时间分辨荧光免疫分析法在结核性胸腔积液中的诊断价值

Diagnostic Value of CFP10 Time-resolved Fluoroimmunoassay in Tuberculosis Pleural Effusion

目的 对基于时间分辨荧光免疫分析技术(time-resolved fluoroimmunoassay,TRFIA)诊断结核性胸腔积液的新方法进行临床评价。方法 共收集191例疑似结核性胸腔积液标本。采用TRFIA检测胸腔积液标本中结核分枝杆菌培养滤液蛋白-10(CFP10),并与培养、涂片及T.SPOT.TB进行比较。结果 有效检测标本174例,其中100例临床综合诊断为结核性胸腔积液,74例诊断为非结核性胸腔积液。以临床综合诊断为金标准,CFP10蛋白时间分辨荧光免疫分析法(CFP10-TRFIA)检测结核性胸腔积液患者的敏感度为42%(42/100)高于细菌学方法(P<0.05),特异性为90.5%(67/74)优于T.SPOT.TB(P<0.05),阳性预测值为84%(42/50),阴性预测值为53.2%(66/124)。其中24例培养阳性患者中,CFP10-TRFIA共检测出24例。结论 CFP10-TRFIA可提高结核性胸腔积液的检出率,可作为结核性胸腔积液的快速诊断工具并为临床及时治疗提供参考。

Objective To evaluate the mycobacterium tuberculosis specific antigen culture filtrate protein10 time-resolved fluoroimmunoassay（CFP10-TRFIA） for the diagnosis of tuberculous pleural effusion（TPE）. Methods A total of 191 suspected TPE patients were enrolled. CFP10-TRFIA were performed and compared with culture、acid fast stain and T. SPOT. TB. Results Eventually 174 sample results were analysed,of which 100 patients were diagnosed as TPE,and 74 patients were diagnosed as non-tuberculosis pleural effusion according to the composite reference standards（CRS）. The sensitivity of CFP10-TRFIA（42%,42/100） was higher than bacteriologic methods（P〈0.05）,the specificity（90.5%,67/74） was higher than T. SPOT. TB（P〈0.05）,PPV and NPV of CFP10-TRFIA in diagnosing TPE was 84%（42/50） and 53. 2%（66/124）. Also,CFP10-TRFIA has identified all 24 culture positive samples. Conclusion CFP10-TRFIA can enhance the detection rate of TPE and provide treatment reference for clinicians as a fast diagnosing technic.