High accuracy of recombinant fusion protein early secretory antigenic target protein 6-culture filtrate protein 10 skin test for the detection of tuberculosis infection: a phase III, multi-centered, double-blind, hospital-based, randomized controlled trial

被引：5

作者：

Xia, Lu ^{[1
]}

Xu, Miao ^{[2
]}

Li, Feng ^{[1
]}

Li, Tao ^{[1
]}

Yang, Heng ^{[1
]}

Wang, Weihua ^{[3
]}

Wu, Qi ^{[4
]}

Li, Youlun ^{[5
]}

Chen, Xiaohong ^{[6
]}

Ou, Qinfang ^{[7
]}

Chu, Naihui ^{[8
]}

Pan, Hongqiu ^{[9
]}

Deng, Qunyi ^{[1
,10
]}

Mei, Xiaodong ^{[1
,11
]}

Lowrie, Douglas B. ^{[1
,10
]}

Liu, Xuhui ^{[1
,10
]}

Wang, Guozhi ^{[2
]}

Lu, Shuihua ^{[1
,10
]}

机构：

[1] Fudan Univ, Shanghai Publ Hlth Clin Ctr, Dept TB, Shanghai, Peoples R China

[2] Natl Inst Food & Drug Control, Inst Control Biol Prod, Beijing, Peoples R China

[3] Wuhan Pulm Hosp, Dept Pulm Med, Wuhan, Peoples R China

[4] Tianjin Univ, Tianjin Haihe Hosp, Dept Pulm Med, Tianjin, Peoples R China

[5] Chongqing Med Univ, Affiliated Hosp 1, Dept Pulm Med, Chongqing, Peoples R China

[6] Fuzhou Pulm Hosp Fujian, Dept TB, Fuzhou, Peoples R China

[7] Fifth Peoples Hosp Wuxi, Dept Pulm Med, Wuxi, Peoples R China

[8] Capital Med Univ, Beijing Chest Hosp, Dept TB, Beijing, Peoples R China

[9] Third Peoples Hosp Zhenjiang, Dept Pulm Med, Zhenjiang, Peoples R China

[10] Shenzhen Third Peoples Hosp, Natl Clin Res Ctr Infect Dis, Shenzhen, Peoples R China

[11] Univ Sci & Technol China, Affiliated Hosp 1, Anhui Prov Hosp, Dept Pulm Med, Hefei, Peoples R China

来源：

INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES | 2023年 / 126卷

关键词：

China; Tuberculosis; Skin test; ESAT6-CFP10; Clinical trial; Diagnosis; DIAGNOSIS; ASSAYS;

D O I：

10.1016/j.ijid.2022.11.014

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

Objectives: To verify the diagnostic utility of recombinant fusion protein ESAT6-CPF10 (EC), a novel skin test reagent to detect Mycobacterium tuberculosis infection. Methods: A multi-centered, double-blind, randomized controlled trial was conducted from December 17, 2015, to March 2, 2018. Participants involved in this study included those with active tuberculosis (TB), suspected pulmonary TB, or non-TB pulmonary disease. Each participant received three tests simultane-ously, TB-specific enzyme-linked immunospot assay (T-SPOT.TB), tuberculin skin test (TST), and EC skin test (ECST), and adverse events were reported. Results: Diagnostic accuracy was analyzed using data from 1085 protocol-compliant participants. The sen-sitivities of the ECST, TST, and T-SPOT.TB were 91.2% (95% CI, 89.0-93.2%), 91.4% (95% CI, 89.1-93.3%), and 92.1% (95% CI, 89.9-93.9%), respectively. The specificities of the ECST (69.7%, 95% CI, 64.5-74.5%) and T-SPOT.TB (76.1%, 95% CI, 71.2-80.5%) were significantly higher than the TST (54.4%, 95% CI, 48.9-59.7%). The agreements between ECST and TST (kappa = 0.632) and between ECST and T-SPOT.TB (kappa = 0.780) were substantial. No severe adverse event was reported. Conclusion: The diagnostic performance of the ECST was close to the T-SPOT.TB assay in the detection of TB infection and indicated good potential for clinical application in common scenarios. & COPY; 2022 The Author(s). Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY-NC-ND license ( http://creativecommons.org/licenses/by-nc-nd/4.0/ )

引用

页码：98 / 103

页数：6