"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"

作者全名："Xia, Lu; Xu, Miao; Li, Feng; Li, Tao; Yang, Heng; Wang, Weihua; Wu, Qi; Li, Youlun; Chen, Xiaohong; Ou, Qinfang; Chu, Naihui; Pan, Hongqiu; Deng, Qunyi; Mei, Xiaodong; Lowrie, Douglas B.; Liu, Xuhui; Wang, Guozhi; Lu, Shuihua"

作者地址："[Xia, Lu; Li, Feng; Li, Tao; Yang, Heng; Deng, Qunyi; Mei, Xiaodong; Lowrie, Douglas B.; Liu, Xuhui; Lu, Shuihua] Fudan Univ, Shanghai Publ Hlth Clin Ctr, Dept TB, Shanghai, Peoples R China; [Xu, Miao; Wang, Guozhi] Natl Inst Food & Drug Control, Inst Control Biol Prod, Beijing, Peoples R China; [Wang, Weihua] Wuhan Pulm Hosp, Dept Pulm Med, Wuhan, Peoples R China; [Wu, Qi] Tianjin Univ, Tianjin Haihe Hosp, Dept Pulm Med, Tianjin, Peoples R China; [Li, Youlun] Chongqing Med Univ, Affiliated Hosp 1, Dept Pulm Med, Chongqing, Peoples R China; [Chen, Xiaohong] Fuzhou Pulm Hosp Fujian, Dept TB, Fuzhou, Peoples R China; [Ou, Qinfang] Fifth Peoples Hosp Wuxi, Dept Pulm Med, Wuxi, Peoples R China; [Chu, Naihui] Capital Med Univ, Beijing Chest Hosp, Dept TB, Beijing, Peoples R China; [Pan, Hongqiu] Third Peoples Hosp Zhenjiang, Dept Pulm Med, Zhenjiang, Peoples R China; [Deng, Qunyi; Lowrie, Douglas B.; Liu, Xuhui; Lu, Shuihua] Shenzhen Third Peoples Hosp, Natl Clin Res Ctr Infect Dis, Shenzhen, Peoples R China; [Mei, Xiaodong] Univ Sci & Technol China, Affiliated Hosp 1, Anhui Prov Hosp, Dept Pulm Med, Hefei, Peoples R China"

通信作者："Wang, GZ (通讯作者)，Natl Inst Food & Drug Control, Inst Control Biol Prod, Beijing, Peoples R China.; Liu, XH; Lu, SH (通讯作者)，Shenzhen Third Peoples Hosp, Natl Clin Res Ctr Infect Dis, Shenzhen, Peoples R China."

来源：INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES

ESI学科分类：IMMUNOLOGY

WOS号：WOS:001026207900001

JCR分区：Q1

影响因子：4.8

年份：2023

卷号：126

期号：　

开始页：98

结束页：103

文献类型：Article

关键词：China; Tuberculosis; Skin test; ESAT6-CFP10; Clinical trial; Diagnosis

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/ )"

基金机构：Shanghai Municipal Health Commission [shslczdzk03002]; Shenzhen Key Medical Discipline Construction Fund [SZGSP010]

基金资助正文："The phase III trial was funded by Anhui Longcom Biologic Pharmacy Co. Ltd., China. This study received grant support from the Shanghai Municipal Health Commission (shslczdzk03002) and Shenzhen Key Medical Discipline Construction Fund (SZGSP010) ."