γ干扰素释放试验对结核性淋巴结炎的诊断价值研究

doi:10.24920/003497

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This study investigated the diagnostic performance of T-SPOT.TB for tuberculous lymphadenitis(TBL). The authors suggest that T-SPOT.TB is a rapid and simple diagnostic test for TBL with a high sensitivity and high negative predictive value.

Abstract

Objective The aim of this study was to evaluate the diagnostic performance of T-SPOT.TB for tuberculous lymphadenitis. Methods 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 ⁶ 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. Results 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 ⁶ PBMCs] was higher than that in non-TBL patients [0 (0-30) /10 ⁶PBMCs] with a significant difference (Z=-5.306, P <0.001).Conclusion T-SPOT.TB is a rapid and simple diagnostic test for TBL with a high sensitivity and negative predictive value.

Key words: Tuberculous lymphadenitis (TBL), T-SPOT.TB, diagnostic test, sensitivity, specificity

Funding: Fund supported by the Ministry of Science and Technology of the People’s Republic of China(2014ZX10003003);Chinese Academy of Medical Sciences Initiative for Innovative Medicine(2016-12M-1-013);Chinese Academy of Medical Sciences Fund for Tuberculosis Research(2016ZX310183-4)

Xinchao Liu, Susu Ye, Wenze Wang, Yueqiu Zhang, Lifan Zhang, Xiaocheng Pan, Ziyue Zhou, Miaoyan Zhang, Jianghao Liu, Zhiyong Liang, Xiaoqing Liu. Diagnostic Utility of Interferon-Gamma Release Assay in Tuberculous Lymphadenitis[J].Chinese Medical Sciences Journal, 2019, 34(4): 233-240.

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References 32.

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Characteristic	Confirmed TBL n=9	Probable TBL n=28	Indeterminate n=10	Non-TBL n=30
Age (years, mean±SD)	43.1±17.3	46.5±16.0	49.9±11.9	50.0±12.0
Gender (n)
Male	5	7	4	12
Female	4	21	6	18
TB history positive (n)	1	6	0	1
Co-Medication (n)
Steroids	1	5	2	2
Immunosuppressive agent*	1	2	0	1
Underlying condition [n(%)]	7 (77.8%)	8 (28.6%)	3 (30%)	6 (20%)
Cancer	1	1	1	2
Diabetes mellitus	2	2	1	2
Chronic liver diseases	2	1	1	0
Chronic kidney diseases	1	0	0	1
Autoimmune diseases	1	4	0	1
Blood tests [median (IQR)]
Leukocyte (×10⁹/L)	7.6 (6.0-8.4)	6.1 (4.8-7.7)	4.2 (4.0-6.2)	7.8 (4.6-11.8)
Lymphocyte(×10⁹/L)	1.6 (1.1-3.1)	1.4 (1.1-1.8)	1.0 (0.8-1.5)	1.4 (1.0-1.9)
Erythrocyte sedimentation rate (mm/h)	38.0 (13.0-57.0)	12.0 (4.5-19.8)	43.0 (23.0-69.0)	22.0 (14.3-39.3)
C-reactive protein (mg/dL)	8.3 (4.1-49.0)	5.9 (1.7-18.8)	6.1 (2.8-10.3)	4.9 (2.1-32.4)
Site of lymph node biopsy‡ (n)	13	30	14	31
Postauricular	0	2	0	0
Submandibular	1	2	1	0
Cervical	2	7	3	8
Supraclavicular	3	5	1	4
Axillary	1	1	1	2
Mediastinal	4	8	4	13
Celiac	2	5	4	1
Inguinal	0	0	0	3
Histopathologic finding (n)
Granuloma	9	28	10	26
Caseous necrosis	6	9	0	0
Multinucleate giant cell	4	16	4	6

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T-SPOT.TB	Diagnosed by gold standard		Total
T-SPOT.TB	TBL	Non-TBL	Total
Positive	33	10	43
Negative	4	20	24
Total	37	30	67