Department of Infectious Diseases, Peking Union Medical College Hospital.
Department of pathology, Peking Union Medical College Hospital.
Chin Med Sci J. 2019 Nov 12;34(4):233-240. doi: 10.24920/003497.
The aim of this study was to evaluate the diagnostic performance of T-SPOT.TB for tuberculous lymphadenitis. Suspected tuberculous lymphadenitis patients between September 2010 and September 2018 who had both peripheral blood T-SPOT.TB test and lymph node biopsy were retrospectively enrolled in this study. The cutoff value of T-SPOT.TB test for peripheral blood was set as 24 spot forming cell (SFC)/10 periphreral blood monocyte cell (PBMC) according to the instruction of testing kits. The gold standard for diagnosis of TBL was the combination of microbiology results, histopathology results and patient's response to anti-TB treatment. Diagnostic efficacy of T-SPOT.TB was evaluated, including sensitivity, specificity, accuracy, predictive values, and likelihood ratio. Among 91 patients who met the inclusion criteria, we excluded 8 cases with incomplete clinical information and 6 cases who lost to follow-up. According to the gold standard, there were 37 cases of true TBL (9 confirmed TBL and 28 probable TBL), 30 cases of non-TBL, and 10 cases of clinically indeterminate diagnosis who were excluded from the final analyses. The T-SPOT.TB tests yielded 43 cases of positive response and 24 cases of negative response. The sensitivity, specificity, accuracy, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR) and negative likelihood ratio (NLR) of peripheral blood T-SPOT.TB for diagnosing TBL were 89.2%, 66.7%, 79.1%, 76.7%, 83.3%, 2.68 and 0.16, respectively. The number of SFCs of T-SPOT.TB in TBL patients [432(134-1264)/10 PBMCs] was higher than that in non-TBL patients [0 (0-30) /10 PBMCs] with a significant difference (Z=-5.306, P <0.001). T-SPOT.TB is a rapid and simple diagnostic test for TBL with a high sensitivity and negative predictive value.
本研究旨在评估 T-SPOT.TB 在结核性淋巴结炎中的诊断性能。回顾性纳入 2010 年 9 月至 2018 年 9 月间既有外周血 T-SPOT.TB 检测又有淋巴结活检的疑似结核性淋巴结炎患者。根据试剂盒说明书,外周血 T-SPOT.TB 检测的截断值设定为 24 个斑点形成细胞(SFC)/10 个外周血单个核细胞(PBMC)。结核性淋巴结炎的诊断金标准是微生物学结果、组织病理学结果和患者对抗结核治疗的反应的综合判断。评估 T-SPOT.TB 的诊断效能,包括敏感性、特异性、准确性、预测值和似然比。在符合纳入标准的 91 例患者中,我们排除了 8 例临床资料不完整的病例和 6 例失访病例。根据金标准,9 例确诊结核性淋巴结炎和 28 例可能结核性淋巴结炎共 37 例为真结核性淋巴结炎,30 例为非结核性淋巴结炎,10 例临床诊断不确定病例被排除在最终分析之外。T-SPOT.TB 检测结果为阳性 43 例,阴性 24 例。外周血 T-SPOT.TB 诊断结核性淋巴结炎的敏感性、特异性、准确性、阳性预测值(PPV)、阴性预测值(NPV)、阳性似然比(PLR)和阴性似然比(NLR)分别为 89.2%、66.7%、79.1%、76.7%、83.3%、2.68 和 0.16。结核性淋巴结炎患者 T-SPOT.TB 的 SFC 数[432(134-1264)/10 PBMC]高于非结核性淋巴结炎患者[0(0-30)/10 PBMC],差异有统计学意义(Z=-5.306,P<0.001)。T-SPOT.TB 是一种快速简便的结核性淋巴结炎诊断试验,具有较高的敏感性和阴性预测值。