特异性三色荧光斑点试验在鉴别疑似结核病发热患者结核感染状态中的诊断准确性。
Diagnostic accuracy of -specific triple-color FluoroSpot assay in differentiating tuberculosis infection status in febrile patients with suspected tuberculosis.
作者信息
Zhang Lifan, Li Yuanchun, Zou Xiaoqing, Ma Huimin, Gao Mengqiu, Ge Qiping, Zhang Yueqiu, Yang Zhengrong, Song Xinuo, Yang Qiwen, Liu Xiaoqing
机构信息
Division of Infectious Diseases, Department of Internal Medicine, State Key Laboratory of Complex Severe and Rare Disease, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Clinical Epidemiology Unit, Peking Union Medical College, International Clinical Epidemiology Network, Beijing, China.
出版信息
Front Immunol. 2025 Jan 8;15:1462222. doi: 10.3389/fimmu.2024.1462222. eCollection 2024.
OBJECTIVE
This study aims to evaluate the diagnostic accuracy of a (MTB)-specific triple-color FluoroSpot assay (IFN-γ/IL-2/TNF-α) in the differentiation of tuberculosis (TB) infection status in febrile patients.
METHOD
Febrile patients with suspected active TB (ATB) were consecutively enrolled. The frequencies and proportions of MTB-specific T cells secreting IFN-γ, IL-2, and TNF-α were detected at the single-cell level by triple-color FluoroSpot assay. The diagnostic index was fitted with a binary logistic regression model, and the diagnostic accuracy was evaluated according to the receiver operating characteristic (ROC) curve. The sensitivity, specificity, predictive values (PV), and likelihood ratios (LR) were calculated.
RESULT
A total of 210 febrile patients were enrolled, 53 patients were diagnosed with ATB (28 pathogen-confirmed vs. 25 clinically diagnosed) and 157 patients were non-ATB (84 with latent tuberculosis infection (LTBI) vs. 73 uninfected with MTB). Additionally, 30 pathogen-confirmed ATB patients were assembled. When diagnosing ATB, the area under the ROC curve (AUROC) of the MTB-specific triple-color FluoroSpot assay was significantly better than that of T-SPOT.TB (0.882 vs. 0.811, = 0.017). With the fitted diagnostic index at a cutoff value of 0.378, the sensitivity, specificity, LR+, and LR- were 74.7%, 93.0%, 10.66, and 0.27, respectively. When differentiating ATB from LTBI, the AUROC of the FluoroSpot assay and T-SPOT.TB was 0.878 and 0.692, respectively ( < 0.001). With a diagnostic index of 0.413, the sensitivity, specificity, LR+, and LR were 77.1%, 85.7%, 5.40, and 0.27, respectively.
CONCLUSION
The MTB-specific triple-color FluoroSpot (IFN-γ/IL-2/TNF-α) might be helpful for the differentiation of TB infection status in febrile patients.
目的
本研究旨在评估一种结核分枝杆菌（MTB）特异性三色荧光斑点试验（IFN-γ/IL-2/TNF-α）在发热患者结核（TB）感染状态鉴别诊断中的准确性。
方法
连续纳入疑似活动性结核（ATB）的发热患者。采用三色荧光斑点试验在单细胞水平检测分泌IFN-γ、IL-2和TNF-α的MTB特异性T细胞的频率和比例。将诊断指标拟合二元逻辑回归模型，并根据受试者工作特征（ROC）曲线评估诊断准确性。计算敏感性、特异性、预测值（PV）和似然比（LR）。
结果
共纳入210例发热患者，53例被诊断为ATB（28例病原体确诊，25例临床诊断），157例为非ATB（84例潜伏结核感染（LTBI），73例未感染MTB）。此外，收集了30例病原体确诊的ATB患者。诊断ATB时，MTB特异性三色荧光斑点试验的ROC曲线下面积（AUROC）显著优于T-SPOT.TB（0.882对0.811，P = 0.017）。拟合诊断指标的截断值为0.378时，敏感性、特异性、阳性似然比（LR+）和阴性似然比（LR-）分别为74.7%、93.0%、10.66和0.27。鉴别ATB与LTBI时，荧光斑点试验和T-SPOT.TB的AUROC分别为0.878和0.692（P < 0.001）。诊断指标为0.413时，敏感性、特异性、LR+和LR分别为77.1%、85.7%、5.40和0.27。
结论
MTB特异性三色荧光斑点试验（IFN-γ/IL-2/TNF-α）可能有助于发热患者结核感染状态的鉴别。
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