Recombinant fusion ESAT6-CFP10 immunogen as a skin test reagent for tuberculosis diagnosis: an open-label, randomized, two-centre phase 2a clinical trial

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Recombinant fusion ESAT6-CFP10 immunogen as a skin test reagent for tuberculosis diagnosis: an open-label, randomized, two-centre phase 2a clinical trial F. Li, M. Xu, C. Qin, L. Xia, Y. Xiong, X. Xi, X. Fan, J. Gu, J. Pu, Q. Wu, S. Lu, G. Wang Clinical Microbiology and Infection Volume 22, Issue 10, Pages 889.e9-889.e16 (October 2016) DOI: 10.1016/j.cmi.2016.07.015 Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases Terms and Conditions

Fig. 1 Flow diagram of trial. (A) Flowchart of participants who received TB-PPD injection in left forearm and ESAT6-CFP10 injection in right forearm. (B) Flowchart of participants who received placebo injection in left forearm and ESAT6-CFP10 injection in right forearm. FAS, full-analysis set; PPD, purified protein derivative (of tuberculin); PPS, per-protocol set; SCC, squamous cell carcinoma; TB, tuberculosis. Clinical Microbiology and Infection 2016 22, 889.e9-889.e16DOI: (10.1016/j.cmi.2016.07.015) Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases Terms and Conditions

Fig. 2 Comparisons of ESAT6-CFP10 skin test with TB-PPD skin test and ELISPOT assay. Comparisons between ESAT6-CFP10 and TB-PPD skin tests in full-analysis set population (A) and per-protocol set population (B) and comparisons between ESAT6-CFP10 skin test and ELISPOT assay in full-analysis set population (C) and per-protocol set population (D) were performed using receiver operating characteristic curve analysis. Area under curve and p value are shown. ELISPOT, enzyme-linked immunospot; PPD, purified protein derivative of tuberculin; TB, tuberculosis. Clinical Microbiology and Infection 2016 22, 889.e9-889.e16DOI: (10.1016/j.cmi.2016.07.015) Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases Terms and Conditions