γ-干扰素释放试验诊断成人肺外结核准确性的系统综述与荟萃分析

doi:10.19982/j.issn.1000-6621.20260145

中国防痨杂志 ›› 2026, Vol. 48 ›› Issue (6): 803-812.doi: 10.19982/j.issn.1000-6621.20260145

γ-干扰素释放试验诊断成人肺外结核准确性的系统综述与荟萃分析

郭宸浩¹(), 刘鑫宇², 詹斯蕊³, 王丽丽², 马梦婷⁴, 李秀梅⁴, 祁琳萍⁴, 李卫平¹

¹ 兰州大学第一医院泌尿外科, 兰州 730000
² 兰州大学口腔医学院, 兰州 730000
³ 兰州大学第一临床医学院, 兰州 730000
⁴ 兰州大学第二临床医学院, 兰州 730000

收稿日期:2026-03-16 出版日期:2026-06-10 发布日期:2026-05-25
通信作者: 郭宸浩 E-mail:ldyyguoch@163.com
基金资助:
甘肃省联合科研基金(25JRRA1254);兰州大学第一医院临床基础研究项目(ldyyyn2022-3);兰州大学第一医院临床基础研究项目(ldyyyn2025-31)

Interferon-gamma release assays for diagnosing extrapulmonary tuberculosis in adults: a systematic review and Meta-analysis

Guo Chenhao¹(), Liu Xinyu², Zhan Sirui³, Wang Lili², Ma Mengting⁴, Li Xiumei⁴, Qi Linping⁴, Li Weiping¹

¹ Department of Urology, The First Hospital of Lanzhou University, Lanzhou 730000, China
² School of Stomatology, Lanzhou University, Lanzhou 730000, China
³ The First Clinical Medical College, Lanzhou University, Lanzhou 730000, China
⁴ The Second Clinical Medical College, Lanzhou University, Lanzhou 730000, China

Received:2026-03-16 Online:2026-06-10 Published:2026-05-25
Contact: Guo Chenhao E-mail:ldyyguoch@163.com
Supported by:
Gansu Province Joint Scientific Research Fund(25JRRA1254);Clinical Basic Research Program of the First Hospital of Lanzhou University(ldyyyn2022-3);Clinical Basic Research Program of the First Hospital of Lanzhou University(ldyyyn2025-31)

摘要/Abstract

摘要：

目的: 系统评估γ-干扰素释放试验(interferon-γ release assay,IGRA)在不同标本类型及检测方法中对成人肺外结核(extrapulmonary tuberculosis,EPTB)的诊断价值,为优化临床诊断路径提供循证依据。方法: 系统检索2014年1月至2025年5月期间的PubMed、Web of Science及Cochrane图书馆数据库,纳入比较商业化IGRA[结核感染T细胞斑点试验(T-SPOT.TB)或QuantiFERON-TB Gold系列]与复合参考标准[培养和(或)临床诊断]的诊断准确性研究。采用双变量随机效应模型合并敏感度、特异度,并进行亚组分析(标本类型、检测方法、疾病类型等)和Meta回归。结果: 共纳入28项研究(32573例参与者)。总体合并敏感度、特异度和曲线下面积(area under curve,AUC)值分别为0.83(95%CI:0.79~0.87)、0.86(95%CI:0.82~0.90)和0.909。IGRA检测体液样本的敏感度与血液样本相当(0.86 vs. 0.84),但特异度更高(0.92 vs. 0.81)。酶联免疫斑点法(enzyme linked immunospot assay,ELISPOT)检测特异度优于酶联免疫吸附试验(enzyme-linked immunosorbent assay,ELISA)(0.86和0.81)。针对结核性胸膜炎,胸腔积液ELISPOT检测的AUC值为0.972,优于血液检测(AUC=0.909)。血液ELISPOT检测在淋巴结结核亚组中显现出良好诊断效能(AUC=0.936)。IGRA对骨关节结核的诊断价值有限(AUC=0.7343)。结论: IGRA是诊断EPTB的有效辅助工具,但检测性能取决于标本类型和检测方法。证据支持对疑似结核性胸膜炎患者优先使用胸腔积液ELISPOT检测,对淋巴结结核优先使用血液ELISPOT检测。骨关节结核诊断中应谨慎解读IGRA结果。

关键词: 干扰素类, 诊断技术和方法, 肺外结核, 评价研究, Meta分析

Abstract:

Objective: To systematically evaluate the diagnostic accuracy of interferon-γ release assays (IGRA) for extrapulmonary tuberculosis (EPTB) in adults across different specimen types and assay methods, and to provide evidence-based guidance for optimizing clinical diagnostic pathways. Methods: A systematic search was conducted across PubMed, Web of Science, and the Cochrane Library databases from January 2014 to May 2025, to identify studies comparing the diagnostic accuracy of commercial IGRA (T-SPOT.TB or QuantiFERON-TB Gold series) with composite reference standards (culture and/or clinical diagnosis). Bivariate random effect models were used to combine sensitivity and specificity, and subgroup analyses (specimen type, detection method, disease type, etc.) and meta-regression were conducted. Results: A total of 28 studies (32573 participants) were included. The overall pooled sensitivity, specificity, and area under curve (AUC) values were 0.83 (95%CI: 0.79-0.87), 0.86 (95%CI: 0.82-0.90), and 0.9089, respectively. The sensitivity of IGRA for detecting body fluid samples was comparable to that of blood samples (0.86 vs. 0.84), but the specificity was higher (0.92 vs. 0.81). The enzyme-linked immunospot assay (ELISPOT) demonstrated superior specificity compared to the enzyme-linked immunosorbent assay (ELISA)(0.86 vs. 0.81). For tuberculous pleurisy, the AUC value of pleural effusion ELISPOT detection was 0.972, which was superior to that of blood detection (AUC=0.909). Blood ELISPOT detection showed good diagnostic performance in the lymph node tuberculosis subgroup (AUC=0.936). IGRA had limited diagnostic value for osteoarticular tuberculosis (AUC=0.734). Conclusion: IGRA is an effective auxiliary tool for diagnosing EPTB, but its detection performance depends on the type of specimen and the detection method. Evidence suggests that for patients suspected of having tuberculous pleurisy, pleural effusion ELISPOT testing should be prioritized, while for lymph node tuberculosis, blood ELISPOT testing should be preferred. In the diagnosis of osteoarticular tuberculosis, IGRA results should be interpreted with caution.

Key words: Interferons, Diagnostic techniques and procedures, Extrapulmonary tuberculosis, Evaluation studies, Meta-analysis

中图分类号:

郭宸浩, 刘鑫宇, 詹斯蕊, 王丽丽, 马梦婷, 李秀梅, 祁琳萍, 李卫平. γ-干扰素释放试验诊断成人肺外结核准确性的系统综述与荟萃分析[J]. 中国防痨杂志, 2026, 48(6): 803-812. doi: 10.19982/j.issn.1000-6621.20260145

Guo Chenhao, Liu Xinyu, Zhan Sirui, Wang Lili, Ma Mengting, Li Xiumei, Qi Linping, Li Weiping. Interferon-gamma release assays for diagnosing extrapulmonary tuberculosis in adults: a systematic review and Meta-analysis[J]. Chinese Journal of Antituberculosis, 2026, 48(6): 803-812. doi: 10.19982/j.issn.1000-6621.20260145

图/表 9

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评价领域	偏倚风险[项(构成比,%)]			适用性问题[项(构成比,%)]
评价领域	低风险	高风险	不明确	低风险	高风险	不明确
患者选择	18(64.28)	5(17.86)	5(17.86)	27(96.43)	0(0.00)	1(3.57)
指标检测	11(39.29)	1(3.57)	16(57.14)	28(100.00)	0(0.00)	0(0.00)
参考标准	22(78.57)	1(3.57)	5(17.86)	28(100.00)	0(0.00)	0(0.00)
流程与时间	25(89.29)	2(7.14)	1(3.57)	-	-	-

亚组	研究数量(篇)	测试结果(例)				合并敏感度 (95%CI)	Meta回归 P值	合并特异度 (95%CI)	Meta回归 P值
亚组	研究数量(篇)	TP	FP	FN	TN	合并敏感度 (95%CI)	Meta回归 P值	合并特异度 (95%CI)	Meta回归 P值
样本类型							0.010		<0.001
体液	9	155	44	35	416	0.86(0.77~0.95)		0.92(0.87~0.96)
血液	26	3354	3727	647	21557	0.84(0.79~0.89)		0.81(0.77~0.86)
检测方法							P<0.001		<0.001
ELISA	11	545	327	153	1221	0.84(0.77~0.92)		0.81(0.74~0.89)
ELISPOT	24	2964	3444	529	20752	0.85(0.80~0.90)		0.86(0.81~0.90)

协变量	研究数量(篇)	回归系数	RDOR(95%CI)值	P值
体液
检测方法
ELISA	2	-0.488	0.61(0.12~3.03)	0.483
ELISPOT	7	-	1.00(参照)	-
疾病类型
结核性脑膜炎	3	-	1.00(参照)	-
结核性胸膜炎	3	0.874	2.40(0.46~12.54)	0.244
诊断类型(ELISPOT)
确诊队列	7	-0.220	0.80(0.25~2.53)	0.682
疑似队列	7	-	1.00(参照)	-
血液
检测方法
ELISA	9	-0.233	0.79(0.26~2.46)	0.674
ELISPOT	17	-	1.00(参照)	-
疾病类型
结核性脑膜炎	5	-	1.00(参照)	-
结核性胸膜炎	8	-0.156	0.86(0.22~3.39)	0.819
结核性淋巴结炎	6	-0.259	0.77(0.20~2.96)	0.696
诊断类型(ELISPOT)
确诊队列	17	-0.111	0.90(0.21~3.78)	0.874
疑似队列	6	-	1.00(参照)	-
诊断类型(ELISA)
确诊队列	9	0.083	1.09(0.24~4.85)	0.906
疑似队列	6	-	1.00(参照)	-
地区背景
高结核负担地区	21	-0.163	0.85(0.20~3.59)	0.817
低结核负担地区	5	-	1.00(参照)	-

组别	研究数量 (篇)	敏感度 (95%CI)	特异度 (95%CI)	阳性似然比 (95%CI)	阴性似然比 (95%CI)	诊断比值比 (95%CI)	AUC值
血液ELISPOT	17	0.85 (0.84~0.86)	0.86 (0.85~0.86)	4.40 (2.81~6.91)	0.22 (0.15~0.33)	24.48 (11.48~52.23)	0.899
血液ELISA	9	0.77 (0.74~0.81)	0.78 (0.76~0.80)	3.61 (2.73~4.79)	0.22 (0.13~0.38)	17.91 (8.34~38.49)	0.879
体液ELISPOT	7	0.80 (0.72~0.86)	0.91 (0.88~0.94)	8.96 (6.30~12.73)	0.17 (0.07~0.43)	78.97 (35.73~176.6)	0.962

γ-干扰素释放试验诊断成人肺外结核准确性的系统综述与荟萃分析

Interferon-gamma release assays for diagnosing extrapulmonary tuberculosis in adults: a systematic review and Meta-analysis

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