γ-干扰素释放试验调整后的临界值对不明原因发热患者结核病诊断的影响。

Effect of adjusted cut-offs of interferon-γ release assays on diagnosis of tuberculosis in patients with fever of unknown origin.

作者信息

Shen Yaojie, Qi Xiao, Wu Jing, Gao Yan, Shao Lingyun, Zhang Wenhong, Wang Sen

机构信息

Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China.

Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, Shanghai 200040, China.

出版信息

J Clin Tuberc Other Mycobact Dis. 2021 Dec 20;26:100290. doi: 10.1016/j.jctube.2021.100290. eCollection 2022 Feb.

DOI:10.1016/j.jctube.2021.100290

PMID:35005253

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8717605/

Abstract

BACKGROUND

Tuberculosis (TB) is a leading cause of fever of unknown origin (FUO). In recent years, interferon-γ release assays (IGRAs) have been widely utilized and the cut-off values given by the manufacturers are set in countries where rates of TB are not as high.

METHODS

A prospective cohort study was conducted in a Chinese general hospital to evaluate the diagnostic performance of T-SPOT.TB (T-SPOT) and QuantiFERON-TB Gold (QFT) in detecting active TB (ATB) in a high TB endemic area. Test results were compared with the culture and clinically confirmed diagnosis. Further, we explored an alternative method of interpreting IGRAs by increasing the cut-off values.

RESULTS

The sensitivity and specificity of T-SPOT in detecting ATB were 85.3% (95% CI 81.6-94.0%) and 71.8% (95% CI 67.3-76.0%), respectively. The sensitivity and specificity of QFT were 72.3% (95% CI 62.8-80.1%) and 77.0% (95% CI 72.7-80.8%), respectively. Receiver operating characteristic analysis was used for evaluation of different cut-off values. When the cut-off values were adjusted as 125 spot-forming cells (SFCs)/ 2.5*10 cells for T-SPOT and 4.0 IU/ml for QFT, the specificity could be improved to > 90.0% (90.3% and 94.1%, respectively), and the sensitivity were 43.1% and 41.6%, respectively. The new adjusted cut-off values were validated in another independent validation cohort.

CONCLUSION

The adjusted cut-off values of the two assays considerably improved the diagnostic value when applied to FUO patients in clinical settings.

摘要

背景

结核病（TB）是不明原因发热（FUO）的主要原因。近年来，干扰素-γ释放试验（IGRAs）已被广泛应用，且制造商给出的临界值是在结核病发病率不那么高的国家设定的。

方法

在中国一家综合医院进行了一项前瞻性队列研究，以评估T-SPOT.TB（T-SPOT）和结核感染T细胞检测（QFT）在高结核病流行地区检测活动性结核病（ATB）的诊断性能。将检测结果与培养结果及临床确诊诊断进行比较。此外，我们通过提高临界值探索了一种解释IGRAs的替代方法。

结果

T-SPOT检测ATB的敏感性和特异性分别为85.3%（95%CI 81.6 - 94.0%）和71.8%（95%CI 67.3 - 76.0%）。QFT的敏感性和特异性分别为72.3%（95%CI 62.8 - 80.1%）和77.0%（95%CI 72.7 - 80.8%）。采用受试者工作特征分析来评估不同的临界值。当将T-SPOT的临界值调整为125个斑点形成细胞（SFCs）/2.5×10⁶细胞，QFT的临界值调整为4.0 IU/ml时，特异性可提高到>90.0%（分别为90.3%和94.1%），敏感性分别为43.1%和41.6%。新调整的临界值在另一个独立的验证队列中得到了验证。