时间分辨荧光分析法测定抗原培养滤液蛋白10对结核性胸腔积液诊断的临床研究

摘要

Objective To probe the clinical value of time-resolved fluorometric immuno assay (TRFIA) in detecting CFP10 for early diagnosing tuberculous pleural effusion.Methods The specimen of pleural effusions from 106 patients of tuberculous pleural effusion and 40 patients of non-tuberculous pleural effusion were collected.TRFIA method was set up to detect CFP10 antigen in pleural effusion,and the results were compared with those of ELISA.Results The mean recovery rate of TRFIA to CFP10 was 96.87 ％ (r2 =0.998).The mean inter and intra assay CVs were 2.98 ％ and 4.20 ％ respectively.With TRFIA method,the Log concentration of CFP10 in patients group [(1.924 ±0.57) μg · L-1] was higher than that of control group [(0.108 ± 0.03) μg · L-1],and the difference was significant (t =24.72,P ＜ 0.01).AUC for ROC curve in patients group was 0.923.As the critical value was 11.86 μg · L-1,the sensitivity and specificity of TRFIA were 95.28％ and 92.50％ respectively,both of which were higher than those of ELISA.Conclusions Detection of CFP10 in tuberculous pleural effusion with TRFIA has high sensitivity and specificity,and it is in favor of early diagnosis of tuberculous pleural effusion.%目的 探讨时间分辨荧光免疫分析法(TRFIA)测定抗原培养滤液蛋白10(CFP10)对于早期诊断结核性胸腔积液的临床价值.方法 选择106例结核性胸腔积液病例与40例非结核性胸腔积液病例的胸腔积液标本.建立TRFIA法检测胸腔积液中CFP10抗原,并与酶联免疫吸附法(ELISA)的检测结果比较.结果 TRFIA法对CFP10抗原的平均回收率为96.87％,标准曲线相关系数r2=0.998,平均批内变异系数(CV)与批间CV分别为2.98％及4.20％,TRFIA法检测观察组CFP10的Log浓度为(1.924±0.57) μg·L-1,对照组为(0.108±0.03) μg·L-1,两组比较差异有统计学意义(t=24.72,P＜0.01).观察组ROC曲线的AUC=0.923.取临界值为11.86μg·L-1时,灵敏度与特异度分别为95.28％与92.50％,均高于ELISA法.结论 TRFIA法测定结核性胸腔积液中CFP10蛋白具有很高的灵敏度与特异度,有利于早期诊断结核性胸腔积液.