[一种新型基于特异性T细胞的结核病检测方法的诊断性能]
[Diagnostic performance of a novel specific T-Cell based assay for tuberculosis].
作者信息
Pan L P, Gao M Q, Jia H Y, Huang M L, Wei R R, Sun Q, Xing A Y, Du B P, Zhang Z D
机构信息
Department of Tuberculosis, Beijing Chest Hospital Affiliated to Capital Medical University, Beijing 110149, China.
出版信息
Zhonghua Jie He He Hu Xi Za Zhi. 2021 May 12;44(5):443-449. doi: 10.3760/cma.j.cn112147-20200821-00916.
To evaluate the diagnosic performance of a novel (MTB) specific T-cell based assay for tuberculosis, which targets the mRNA detection of interferon gamma-induced protein 10 (IP-10). Suspected tuberculosis patients were prospectively and consecutively recruited in Beijing Chest Hospital between March 2018 and November 2019, and individuals with lower risk of MTB infection were also recruited. IP-10.TB and T-SPOT.TB assays were simulataneously performed on peripheral blood samples. The diagnostic performance of IP-10.TB and T-SPOT.TB were analyzed using the receiver operating characteristic curve. Accordance of IP-10.TB and T-SPOT.TB was analyzed by Cohen's kappa test, while the correlation between the expression level of IP-10 mRNA in IP-10.TB test and the number of SFCs in T-SPOT.TB test were analyzed by Pearson correlation test. A total of 235 patients with tuberculosis, 110 patients with other diseases and 153 individuals with lower risk of MTB infection were included in the final analysis. No significant difference was detected in the rate of indeterminate results between IP-10.TB assay (3/498, 0.60%) and T-SPOT.TB assay (6/498, 1.21%). The total sensitivity and specificity of IP-10.TB assay were 91.3% (95% 86.8%-94.6%) and 81.1% (95% 75.8%-85.7%). The specificity of IP-10.TB in individuals with lower risk of MTB infection was 98.0% (95% 94.4%-99.6%). The total sensitivity and specificity of T-SPOT.TB assay were 93.0% (95% 88.9%-96.0%) and 83.8% (95% 78.7%-88.1%). The specificity of T-SPOT.TB in individuals with lower risk of MTB infection was 100% (95% 97.6%-100.0%). No significant differences were detected in sensitivity and specificity between IP-10.TB and T-SPOT.TB assays (>0.05). The positive coincidence rate of these 2 methods was 91.0% (95% 87.5%-94.5%), and the negative coincidence rate was 88.9% (95% 84.9%-92.9%) and the total coincidence rate was 90.0% (95% 87.3%-92.6%). The Cohen's kappa value was 0.80 (95% 0.75-0.85, <0.001) between IP-10.TB and T-SPOT.TB assays. These results showed that the diagnostic performance of IP-10.TB was consistent with that in T-SPOT.TB, and this test could be a novel adjunctive tool for the diagnosis of tuberculosis.
为评估一种新型的基于结核分枝杆菌（MTB）特异性T细胞的检测方法对结核病的诊断性能，该方法靶向检测干扰素γ诱导蛋白10（IP-10）的mRNA。2018年3月至2019年11月期间，在北京胸科医院前瞻性连续招募疑似结核病患者，同时也招募MTB感染风险较低的个体。对采集的外周血样本同时进行IP-10.TB检测和T-SPOT.TB检测。采用受试者工作特征曲线分析IP-10.TB检测和T-SPOT.TB检测的诊断性能。通过Cohen's kappa检验分析IP-10.TB检测和T-SPOT.TB检测结果的一致性，同时采用Pearson相关检验分析IP-10.TB检测中IP-10 mRNA表达水平与T-SPOT.TB检测中斑点形成细胞（SFC）数量之间的相关性。最终纳入分析的有235例结核病患者、110例其他疾病患者和153例MTB感染风险较低的个体。IP-10.TB检测（3/498，0.60%）和T-SPOT.TB检测（6/498，1.21%）的不确定结果发生率差异无统计学意义。IP-10.TB检测的总敏感性和特异性分别为91.3%（95%可信区间86.8%-94.6%）和81.1%（95%可信区间75.8%-85.7%）。IP-10.TB检测在MTB感染风险较低个体中的特异性为98.0%（95%可信区间94.4%-99.6%）。T-SPOT.TB检测的总敏感性和特异性分别为93.0%（95%可信区间88.9%-96.0%）和83.8%（95%可信区间78.7%-88.1%）。T-SPOT.TB检测在MTB感染风险较低个体中的特异性为100%（95%可信区间97.6%-100.0%）。IP-10.TB检测和T-SPOT.TB检测的敏感性和特异性差异无统计学意义（P>0.05）。这两种方法的阳性符合率为91.0%（95%可信区间87.5%-94.5%），阴性符合率为88.9%（95%可信区间84.9%-92.9%），总符合率为90.0%（95%可信区间87.3%-92.6%）。IP-10.TB检测和T-SPOT.TB检测的Cohen's kappa值为0.80（95%可信区间0.75-0.85，P<0.001）。这些结果表明，IP-10.TB检测的诊断性能与T-SPOT.TB检测相当，该检测可作为结核病诊断的一种新型辅助工具。
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