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.	中華醫學會結核病學分會. 肺結核診斷和治療指南. 中華結核病和呼吸雜志, 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.	劉紅, 黃永杰, 王靜, 等. 結核感染T細胞斑點試驗在疑似結核病患者診斷中的價值研究. 中華結核和呼吸雜志, 2014, 37(3):192-196.
9.	潘麗萍, 賈紅彥, 劉菲, 等. γ-干擾素釋放試驗對不同年齡組疑似肺結核的輔助診斷價值. 中華結核和呼吸雜志, 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, 張麗帆, 劉曉清. 評價γ干擾素釋放分析T-SPOT.TB在肺外結核病診斷中的敏感性. 中國醫學科學院學報, 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.	曾誼, 林云霞, 宋梅梅, 等. T-SPOT.TB快速檢測在菌陰肺結核中的診斷價值. 中華醫學會結核病學分會2012年學術大會論文集, 2012:150-152.
15.	李悅, 吳琦. T-SPOT.TB在菌陰肺結核診斷中的價值研究. 醫學信息, 2015, (42):65-65.
16.	李婷, 時代強. T細胞斑點試驗在痰菌涂陰肺結核中的診斷價值. 中華臨床感染病雜志, 2014, 7(3):255-257.
17.	崔丹, 趙杰, 李志惠, 等. γ-干擾素釋放試驗與結核菌素試驗對菌陰肺結核的診斷價值. 解放軍醫藥雜志, 2015, 27(7):89-91.
18.	曾誼, 馮梟, 宋梅梅, 等. 酶聯免疫斑點試驗在菌陰肺結核診斷中的價值. 中國防癆雜志, 2012, 34(2):100-102.
19.	李紅, 方勇, 郝曉輝, 等. 外周血T-SPOT試驗對菌陰肺結核診斷價值的研究. 中華醫學會結核病學分會2011年學術會議論文集. 2011:24-29.
20.	杜巖青, 張立, 馮爽, 等. 探討T-SPOT.TB、CA125、TB-Ab在痰菌陰性肺結核診斷中的價值. 中國現代醫生, 2014, 52(32):43-45.
21.	趙冬梅, 李婷, 何彥清, 等. 結核感染的T細胞血液檢測對菌陰肺結核診斷意義. 中華醫學會結核病分會2013年學術大會論文集, 2013:223-224.
22.	劉榮梅, 馬麗萍, 張立群. γ-干擾素釋放分析試驗在肺結核病中的診斷價值. 北京醫學, 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.	張天嵩, 鐘文昭. Meta-DiSc軟件在診斷試驗Meta分析中的應用. 循證醫學, 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, 劉厚明, 鄧群益, 等. γ-干擾素釋放試驗在肺結核和非結核分枝桿菌肺病鑒別診斷中的應用價值. 中國防癆雜志, 2014, 36(6):477-481.
31.	劉佳慶, 張立, 孫海柏, 等. γ-干擾素釋放試驗在肺結核早期診斷中的應用. 山東醫藥, 2013, 53(3):82-84.
32.	章淑夢, 周華, 符一騏, 等. γ-干擾素釋放試驗在活動性結核病診斷中的臨床價值. 中華結核和呼吸雜志, 2014, 37(5):372-373.

1. World Health Organization. Global Tuberculosis Report 2015. Geneva:World Health Organization, 2015.
2. 中華醫學會結核病學分會. 肺結核診斷和治療指南. 中華結核病和呼吸雜志, 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. 劉紅, 黃永杰, 王靜, 等. 結核感染T細胞斑點試驗在疑似結核病患者診斷中的價值研究. 中華結核和呼吸雜志, 2014, 37(3):192-196.
9. 潘麗萍, 賈紅彥, 劉菲, 等. γ-干擾素釋放試驗對不同年齡組疑似肺結核的輔助診斷價值. 中華結核和呼吸雜志, 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, 張麗帆, 劉曉清. 評價γ干擾素釋放分析T-SPOT.TB在肺外結核病診斷中的敏感性. 中國醫學科學院學報, 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. 曾誼, 林云霞, 宋梅梅, 等. T-SPOT.TB快速檢測在菌陰肺結核中的診斷價值. 中華醫學會結核病學分會2012年學術大會論文集, 2012:150-152.
15. 李悅, 吳琦. T-SPOT.TB在菌陰肺結核診斷中的價值研究. 醫學信息, 2015, (42):65-65.
16. 李婷, 時代強. T細胞斑點試驗在痰菌涂陰肺結核中的診斷價值. 中華臨床感染病雜志, 2014, 7(3):255-257.
17. 崔丹, 趙杰, 李志惠, 等. γ-干擾素釋放試驗與結核菌素試驗對菌陰肺結核的診斷價值. 解放軍醫藥雜志, 2015, 27(7):89-91.
18. 曾誼, 馮梟, 宋梅梅, 等. 酶聯免疫斑點試驗在菌陰肺結核診斷中的價值. 中國防癆雜志, 2012, 34(2):100-102.
19. 李紅, 方勇, 郝曉輝, 等. 外周血T-SPOT試驗對菌陰肺結核診斷價值的研究. 中華醫學會結核病學分會2011年學術會議論文集. 2011:24-29.
20. 杜巖青, 張立, 馮爽, 等. 探討T-SPOT.TB、CA125、TB-Ab在痰菌陰性肺結核診斷中的價值. 中國現代醫生, 2014, 52(32):43-45.
21. 趙冬梅, 李婷, 何彥清, 等. 結核感染的T細胞血液檢測對菌陰肺結核診斷意義. 中華醫學會結核病分會2013年學術大會論文集, 2013:223-224.
22. 劉榮梅, 馬麗萍, 張立群. γ-干擾素釋放分析試驗在肺結核病中的診斷價值. 北京醫學, 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. 張天嵩, 鐘文昭. Meta-DiSc軟件在診斷試驗Meta分析中的應用. 循證醫學, 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, 劉厚明, 鄧群益, 等. γ-干擾素釋放試驗在肺結核和非結核分枝桿菌肺病鑒別診斷中的應用價值. 中國防癆雜志, 2014, 36(6):477-481.
31. 劉佳慶, 張立, 孫海柏, 等. γ-干擾素釋放試驗在肺結核早期診斷中的應用. 山東醫藥, 2013, 53(3):82-84.
32. 章淑夢, 周華, 符一騏, 等. γ-干擾素釋放試驗在活動性結核病診斷中的臨床價值. 中華結核和呼吸雜志, 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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