Diagnostic Value of T-SOPT.TB in Patients of China with Bacterium Negative Pulmonary Tuberculosis: A Meta-analysis_Chinese Journal of Evidence-Based Medicine

Authors：

 HUANGYi ¹ , HUANGBin ¹ , HUXin ¹ , ABUDUJilili·julaiti ² ,  QIMANGULI·Wushouer ^1,2

1. Department of Respiratory Medicine, The First Affiliated Hospital of Xinjiang Medical University, Urumqi 830054, China;
2. Changji Branch Hospital, the First Affiliated Hospital of Xinjiang Medical University, Changji 831100, Xinjiang, China;

Corresponding author：

QIMANGULI·Wushouer, Email: qimenw@hotmail.com

Keywords：

T-SPOT.TB; Bacterium negative pulmonary tuberculosis; Diagnosis; Meta-analysis; Chinese

DOI：

10.7507/1672-2531.20160209

Video：

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Objective To systematically review the diagnosis value of T cell ELISA Spot (T-SOPT.TB) in for bacterium negative pulmonary tuberculosis in Chinese. Methods We electronically searched databases including PubMed, CBM, CNKI, WanFang Data and VIP from inception to December 31^st, 2015 to collect studies about T-SPOT.TB in diagnosis bacterium negative pulmonary tuberculosis in Chinese. Two researchers independently screened literatures, extracted data, and assessed the risk of bias of included studies, and then meta-analysis was performed by using Stata 12.1 and Meta-DiSc 1.4 software. Results A total of 11 studies including 1 413 patients and 1 256 controls were included. The results of meta-analysis showed that the pooled sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, diagnosis odds ratio and area under SROC curve for T-SPOT.TB diagnosis bacterium negative pulmonary tuberculosis was 83% (95%CI 0.81 to 0.85), 86% (95%CI 0.84 to 0.88), 5.73 (95%CI 4.99 to 6.59), 0.20 (95%CI 0.18 to 0.23), 31.09 (95%CI 25.11 to 38.49), and 0.92, respectively. Conclusion As a rapid and accurate method for diagnosis of bacterium negative pulmonary tuberculosis, T-SPOT.TB has a high diagnostic efficiency for bacterium negative pulmonary tuberculosis in Chinese.

Citation： HUANGYi, HUANGBin, HUXin, ABUDUJilili·julaiti, QIMANGULI·Wushouer. Diagnostic Value of T-SOPT.TB in Patients of China with Bacterium Negative Pulmonary Tuberculosis: A Meta-analysis. Chinese Journal of Evidence-Based Medicine, 2016, 16(12): 1381-1387. doi: 10.7507/1672-2531.20160209 Copy

1.	World Health Organization. Global Tuberculosis Report 2015. Geneva:World Health Organization, 2015.
2.	中华医学会结核病学分会. 肺结核诊断和治疗指南. 中华结核病和呼吸杂志, 2001, 24(1):70-74.
3.	Carrara S, Vincenti D, Petros ilo N, et al. Use of a T cell-based assay for monitoring efficacy of antituberculosis therapy. Clin Infect Dis, 2004, 38(5):754-756.
4.	Colangeli R, Spencer JS, Bifani P, et al. MTSA-10, the product of the Rv3874 gene of Mycobacterium tuberculosis, elicits tuberculosisspecific, delayed-type hypersensitivity in guinea pigs. Infect Immun, 2000, 68(2):990-993.
5.	Berthet FX, Rasmussen PB, Rosenkrands I, et al. A Mycobacterium tuberculosis operon encoding ESAT-6 and a novel low-molecularmass culture filtrate protein (CFP-10). Microbiology, 1998, 144(Pt 11):3195-3203.
6.	Mazurek GH, Jereb J, Lobue P, et al. Guidelines for using the QuantiFERON-TB Gold test for detecting Mycobacterium tuberculosis infection, United States. MMWR Recomm Rep, 2005, 54(RR-15):49-55.
7.	Lalvani A. Diagnosing tuberculosis infection in the 21st century:new tools to tackle an old enemy. Chest, 2007, 131(6):1898-1906.
8.	刘红, 黄永杰, 王静, 等. 结核感染T细胞斑点试验在疑似结核病患者诊断中的价值研究. 中华结核和呼吸杂志, 2014, 37(3):192-196.
9.	潘丽萍, 贾红彦, 刘菲, 等. γ-干扰素释放试验对不同年龄组疑似肺结核的辅助诊断价值. 中华结核和呼吸杂志, 2015, 38(12):892 896.
10.	Lee YM, Park KH, Kim SM, et al. Risk factors for false-negative results of T-SPOT.TB and tuberculin skin test in extrapulmonary tuberculosis. Infection, 2013, 41(6):1089-1095.
11.	Meier T, Eulenbruch HP, Wrighton-Smith P, et al. Sensitivity of a new commercial enzyme-linked immunospot assay (T-SPOT.TB) for diagnosis of tuberculosis in clinical practice. Eur J Clin Microbiol Infect Dis, 2005, 24(8):529-536.
12.	霍霏霏, 张丽帆, 刘晓清. 评价γ干扰素释放分析T-SPOT.TB在肺外结核病诊断中的敏感性. 中国医学科学院学报, 2009, 31 (4):449-452.
13.	Sattah MV, Aye SS, Azen C, et al. Interferon-gamma release assay T-SPOT.TB and HIV-related tuberculosis. Int J Tuberc Lung Dis, 2012, 16(2):281-282.
14.	曾谊, 林云霞, 宋梅梅, 等. T-SPOT.TB快速检测在菌阴肺结核中的诊断价值. 中华医学会结核病学分会2012年学术大会论文集, 2012:150-152.
15.	李悦, 吴琦. T-SPOT.TB在菌阴肺结核诊断中的价值研究. 医学信息, 2015, (42):65-65.
16.	李婷, 时代强. T细胞斑点试验在痰菌涂阴肺结核中的诊断价值. 中华临床感染病杂志, 2014, 7(3):255-257.
17.	崔丹, 赵杰, 李志惠, 等. γ-干扰素释放试验与结核菌素试验对菌阴肺结核的诊断价值. 解放军医药杂志, 2015, 27(7):89-91.
18.	曾谊, 冯枭, 宋梅梅, 等. 酶联免疫斑点试验在菌阴肺结核诊断中的价值. 中国防痨杂志, 2012, 34(2):100-102.
19.	李红, 方勇, 郝晓辉, 等. 外周血T-SPOT试验对菌阴肺结核诊断价值的研究. 中华医学会结核病学分会2011年学术会议论文集. 2011:24-29.
20.	杜岩青, 张立, 冯爽, 等. 探讨T-SPOT.TB、CA125、TB-Ab在痰菌阴性肺结核诊断中的价值. 中国现代医生, 2014, 52(32):43-45.
21.	赵冬梅, 李婷, 何彦清, 等. 结核感染的T细胞血液检测对菌阴肺结核诊断意义. 中华医学会结核病分会2013年学术大会论文集, 2013:223-224.
22.	刘荣梅, 马丽萍, 张立群. γ-干扰素释放分析试验在肺结核病中的诊断价值. 北京医学, 2015, 37(2):112-114.
23.	Qiu Y, Wang Y, Lin N, et al. Multicenter clinical evaluation of three commercial reagent kits based on the interferon-gamma release assay for the rapid diagnosis of tuberculosis in China. Int J Infect Dis, 2015, 40:108-112.
24.	Zhu C, Liu Z, Li Z, et al. The performance and limitation of T-SPOT. TB for the diagnosis of TB in a high prevalence setting. J Thorac Dis, 2014, 6(6):713-719.
25.	Whiting PF, Rutjes AW, Westwood ME, et al. QUADAS-2:a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med, 2011, 155(8):529-536.
26.	张天嵩, 钟文昭. Meta-DiSc软件在诊断试验Meta分析中的应用. 循证医学, 2008, 8(2):97-100.
27.	Lalvani A, Pathan AA, McShane H, et al. Rapid detection of Mycobacterium tuberculosis infection by enumeration of antigenspecific T cells. Am J Respir Crit Care Med, 2001, 163(4):824-828.
28.	Metcalfe JZ, Everett CK, Steingart KR, et al. Interferon-gamma release assays for active pulmonary tuberculosis diagnosis in adults in low and middle-income countries:systematic review and metaanalysis. J Infect Dis, 2011, 204(4):1120-1129.
29.	Dai Y, Feng Y, Xu R, et al. Evaluation of interferon-gamma release assays for the diagnosis of tuberculosis:an updated metaanalysis. Eur J Clin Microbiol Infect Dis, 2012, 31(11):3127-3137.
30.	林玲, 刘厚明, 邓群益, 等. γ-干扰素释放试验在肺结核和非结核分枝杆菌肺病鉴别诊断中的应用价值. 中国防痨杂志, 2014, 36(6):477-481.
31.	刘佳庆, 张立, 孙海柏, 等. γ-干扰素释放试验在肺结核早期诊断中的应用. 山东医药, 2013, 53(3):82-84.
32.	章淑梦, 周华, 符一骐, 等. γ-干扰素释放试验在活动性结核病诊断中的临床价值. 中华结核和呼吸杂志, 2014, 37(5):372-373.

1. World Health Organization. Global Tuberculosis Report 2015. Geneva:World Health Organization, 2015.
2. 中华医学会结核病学分会. 肺结核诊断和治疗指南. 中华结核病和呼吸杂志, 2001, 24(1):70-74.
3. Carrara S, Vincenti D, Petros ilo N, et al. Use of a T cell-based assay for monitoring efficacy of antituberculosis therapy. Clin Infect Dis, 2004, 38(5):754-756.
4. Colangeli R, Spencer JS, Bifani P, et al. MTSA-10, the product of the Rv3874 gene of Mycobacterium tuberculosis, elicits tuberculosisspecific, delayed-type hypersensitivity in guinea pigs. Infect Immun, 2000, 68(2):990-993.
5. Berthet FX, Rasmussen PB, Rosenkrands I, et al. A Mycobacterium tuberculosis operon encoding ESAT-6 and a novel low-molecularmass culture filtrate protein (CFP-10). Microbiology, 1998, 144(Pt 11):3195-3203.
6. Mazurek GH, Jereb J, Lobue P, et al. Guidelines for using the QuantiFERON-TB Gold test for detecting Mycobacterium tuberculosis infection, United States. MMWR Recomm Rep, 2005, 54(RR-15):49-55.
7. Lalvani A. Diagnosing tuberculosis infection in the 21st century:new tools to tackle an old enemy. Chest, 2007, 131(6):1898-1906.
8. 刘红, 黄永杰, 王静, 等. 结核感染T细胞斑点试验在疑似结核病患者诊断中的价值研究. 中华结核和呼吸杂志, 2014, 37(3):192-196.
9. 潘丽萍, 贾红彦, 刘菲, 等. γ-干扰素释放试验对不同年龄组疑似肺结核的辅助诊断价值. 中华结核和呼吸杂志, 2015, 38(12):892 896.
10. Lee YM, Park KH, Kim SM, et al. Risk factors for false-negative results of T-SPOT.TB and tuberculin skin test in extrapulmonary tuberculosis. Infection, 2013, 41(6):1089-1095.
11. Meier T, Eulenbruch HP, Wrighton-Smith P, et al. Sensitivity of a new commercial enzyme-linked immunospot assay (T-SPOT.TB) for diagnosis of tuberculosis in clinical practice. Eur J Clin Microbiol Infect Dis, 2005, 24(8):529-536.
12. 霍霏霏, 张丽帆, 刘晓清. 评价γ干扰素释放分析T-SPOT.TB在肺外结核病诊断中的敏感性. 中国医学科学院学报, 2009, 31 (4):449-452.
13. Sattah MV, Aye SS, Azen C, et al. Interferon-gamma release assay T-SPOT.TB and HIV-related tuberculosis. Int J Tuberc Lung Dis, 2012, 16(2):281-282.
14. 曾谊, 林云霞, 宋梅梅, 等. T-SPOT.TB快速检测在菌阴肺结核中的诊断价值. 中华医学会结核病学分会2012年学术大会论文集, 2012:150-152.
15. 李悦, 吴琦. T-SPOT.TB在菌阴肺结核诊断中的价值研究. 医学信息, 2015, (42):65-65.
16. 李婷, 时代强. T细胞斑点试验在痰菌涂阴肺结核中的诊断价值. 中华临床感染病杂志, 2014, 7(3):255-257.
17. 崔丹, 赵杰, 李志惠, 等. γ-干扰素释放试验与结核菌素试验对菌阴肺结核的诊断价值. 解放军医药杂志, 2015, 27(7):89-91.
18. 曾谊, 冯枭, 宋梅梅, 等. 酶联免疫斑点试验在菌阴肺结核诊断中的价值. 中国防痨杂志, 2012, 34(2):100-102.
19. 李红, 方勇, 郝晓辉, 等. 外周血T-SPOT试验对菌阴肺结核诊断价值的研究. 中华医学会结核病学分会2011年学术会议论文集. 2011:24-29.
20. 杜岩青, 张立, 冯爽, 等. 探讨T-SPOT.TB、CA125、TB-Ab在痰菌阴性肺结核诊断中的价值. 中国现代医生, 2014, 52(32):43-45.
21. 赵冬梅, 李婷, 何彦清, 等. 结核感染的T细胞血液检测对菌阴肺结核诊断意义. 中华医学会结核病分会2013年学术大会论文集, 2013:223-224.
22. 刘荣梅, 马丽萍, 张立群. γ-干扰素释放分析试验在肺结核病中的诊断价值. 北京医学, 2015, 37(2):112-114.
23. Qiu Y, Wang Y, Lin N, et al. Multicenter clinical evaluation of three commercial reagent kits based on the interferon-gamma release assay for the rapid diagnosis of tuberculosis in China. Int J Infect Dis, 2015, 40:108-112.
24. Zhu C, Liu Z, Li Z, et al. The performance and limitation of T-SPOT. TB for the diagnosis of TB in a high prevalence setting. J Thorac Dis, 2014, 6(6):713-719.
25. Whiting PF, Rutjes AW, Westwood ME, et al. QUADAS-2:a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med, 2011, 155(8):529-536.
26. 张天嵩, 钟文昭. Meta-DiSc软件在诊断试验Meta分析中的应用. 循证医学, 2008, 8(2):97-100.
27. Lalvani A, Pathan AA, McShane H, et al. Rapid detection of Mycobacterium tuberculosis infection by enumeration of antigenspecific T cells. Am J Respir Crit Care Med, 2001, 163(4):824-828.
28. Metcalfe JZ, Everett CK, Steingart KR, et al. Interferon-gamma release assays for active pulmonary tuberculosis diagnosis in adults in low and middle-income countries:systematic review and metaanalysis. J Infect Dis, 2011, 204(4):1120-1129.
29. Dai Y, Feng Y, Xu R, et al. Evaluation of interferon-gamma release assays for the diagnosis of tuberculosis:an updated metaanalysis. Eur J Clin Microbiol Infect Dis, 2012, 31(11):3127-3137.
30. 林玲, 刘厚明, 邓群益, 等. γ-干扰素释放试验在肺结核和非结核分枝杆菌肺病鉴别诊断中的应用价值. 中国防痨杂志, 2014, 36(6):477-481.
31. 刘佳庆, 张立, 孙海柏, 等. γ-干扰素释放试验在肺结核早期诊断中的应用. 山东医药, 2013, 53(3):82-84.
32. 章淑梦, 周华, 符一骐, 等. γ-干扰素释放试验在活动性结核病诊断中的临床价值. 中华结核和呼吸杂志, 2014, 37(5):372-373.

Chinese Journal of Evidence-Based Medicine

Diagnostic Value of T-SOPT.TB in Patients of China with Bacterium Negative Pulmonary Tuberculosis: A Meta-analysis

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