State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Zhejiang, China.
J Infect Dev Ctries. 2020 Nov 30;14(11):1288-1295. doi: 10.3855/jidc.12063.
The interferon-γ release assays as potent adjunct tools for the quick detection of TB in high burden countries is feasible. In this retrospective study, we aimed to identify the risk factors for negative T-SPOT results in confirmed active tuberculosis.
We consecutively enrolled 1,021 patients who were positive for acid-fast bacilli smear staining or culture-confirmed mycobacterial infection and simultaneously tested with the T-SPOT.TB assay. All of the included specimens were used to discriminate the Mycobacterium species using the biochip assay. We collected basic clinical characteristics and laboratory results for further analysis.
Of the 1,021 patients enrolled in the study, 89 patients were identified as having nontuberculous mycobacteria (NTM). Ninety-nine patients were excluded from the analysis because of indeterminate T-SPOT.TB results, while the remaining 833 patients were identified as having Mycobacterium tuberculosis infection. In total, 159 patients had false-negative T-SPOT.TB results (19.1% of 833). The concordance rate between the T-SPOT.TB results and final diagnoses in females was always lower than that in males. Multivariate logistic regression analysis showed that female sex (OR 1.81; 95% CI 1.19, 2.7; p = 0.006), age (OR 1.02; 95% CI 1.01, 1.03; p = 0.003), acid-fast bacilli (AFB) smear-negative (OR 5.45; 95% CI 3.62, 8.19; p < 0.001), HIV coinfection (OR 6.83; 95% CI 2.73, 17.10; p < 0.001) were associated with negative T-SPOT.TB result.
Female is another independent risk factor of negative T-SPOT.TB results, besides to elder, HIV co-infection, acid-fast bacilli (AFB) smear-negative who are suspected of having active TB infection.
干扰素-γ 释放检测作为在高负担国家快速检测结核病的有力辅助工具是可行的。在这项回顾性研究中，我们旨在确定结核分枝杆菌感染患者中 T 细胞斑点试验（T-SPOT.TB）阴性结果的相关因素。
我们连续纳入了 1021 例经抗酸杆菌涂片染色或培养证实的分枝杆菌感染患者，同时进行 T-SPOT.TB 检测。所有纳入的标本均采用生物芯片法进行分枝杆菌菌种鉴定。我们收集了基本的临床特征和实验室结果进行进一步分析。
在纳入的 1021 例患者中，89 例被诊断为非结核分枝杆菌（NTM）感染。99 例因 T-SPOT.TB 检测结果不确定而被排除在分析之外，而其余 833 例被诊断为结核分枝杆菌感染。共有 159 例患者 T-SPOT.TB 检测结果为阴性（833 例患者的 19.1%）。女性 T-SPOT.TB 检测结果与最终诊断的符合率始终低于男性。多变量逻辑回归分析显示，女性（OR 1.81；95%CI 1.19，2.7；p = 0.006）、年龄（OR 1.02；95%CI 1.01，1.03；p = 0.003）、抗酸杆菌涂片阴性（OR 5.45；95%CI 3.62，8.19；p < 0.001）、HIV 合并感染（OR 6.83；95%CI 2.73，17.10；p < 0.001）是 T-SPOT.TB 检测阴性的相关因素。
除了年龄较大、HIV 合并感染、抗酸杆菌涂片阴性等被怀疑有活动性结核感染的因素外，女性也是 T-SPOT.TB 检测阴性的另一个独立危险因素。
