Recombinant fusion ESAT6-CFP10 immunogen as a skin test reagent for tuberculosis diagnosis in children and adolescents:An open-label,randomized,multicenter phase Ⅲ trialOA
Objective:There are limited data on the use of the creation tuberculin skin test(C-TST)for detecting tuberculosis(TB)infection(TBI)in individuals under 18 years of age.We conducted a study to assess the diagnostic accuracy of C-TST in this population.Methods:A double-blind,randomized controlled trial was conducted across 4 tertiary hospitals in China to evaluate the diagnostic accuracy of the C-TST in detecting TBI in individuals under 18 years of age.Participants with suspected pulmonary TB,extrapulmonary TB,or non-TB pulmonary disease were enrolled.The primary outcome was the diagnostic accuracy of the C-TST.Secondary outcomes included the consistency among C-TST,the traditional tuberculin skin test(TST),and T-SPOT.TB assays in different subgroups,as well as the safety of C-TST.Each participant underwent all 3 tests simultaneously:T-SPOT.TB assay,TST,and C-TST.Results:C-TST showed a sensitivity of 83.0%(95%CI,68.7%-91.9%),while TST and T-SPOT.TB demonstrated sensitivities of 80.9%(95%CI,66.3%-90.4%)and 76.6%(95%CI,61.6%-87.2%),respectively.The specificities of C-TST,TST,and T-SPOT.TB were 100%(95%CI,91.9%-100%),98.0%(95%CI,87.8%-99.9%),and 100%(95%CI,90.9%-100%),respectively.The consistency between C-TST and T-SPOT.TB was high(kappa=0.847).No serious adverse events(AEs)were reported.
Lu Xia;Xu-hui Liu;Miao Xu;Ting Zhang;Guo-zhi Wang;Bao-dong Yuan;Feng Li;Guo-xi Chen;Xi-rong Wu;Yan Guo;Ting Song;A-dong Shen;Tao Li;Shui-hua Lu
Department of Tuberculosis,Shanghai Public Health Clinical Center,Fudan University,Shanghai 200083,China Tuberculosis Research Center,Shanghai Public Health Clinical Center,Fudan University,Shanghai 200083,ChinaDepartment of Tuberculosis,Shanghai Public Health Clinical Center,Fudan University,Shanghai 200083,China Tuberculosis Research Center,Shanghai Public Health Clinical Center,Fudan University,Shanghai 200083,ChinaNational Health Commission Key Laboratory of Research on Quality and Standardization of Biotech Products,National Institutes for Food and Drug Control,Beijing102629,ChinaDepartment of Gastroenterology,Children’s Hospital of Shanghai,Shanghai 200040,ChinaNational Health Commission Key Laboratory of Research on Quality and Standardization of Biotech Products,National Institutes for Food and Drug Control,Beijing102629,ChinaDepartment of Tuberculosis,Wuhan Pulmonary Hospital,Wuhan 430030,Hubei,ChinaDepartment of Tuberculosis,Shanghai Public Health Clinical Center,Fudan University,Shanghai 200083,ChinaDepartment of Tuberculosis,Wuhan Pulmonary Hospital,Wuhan 430030,Hubei,ChinaRespiratory Department,Beijing Children’s Hospital,Capital Medical University,China National Clinical Research Center of Respiratory Diseases,National Center for Children’s Health,Beijing 100101,ChinaRespiratory Department,Beijing Children’s Hospital,Capital Medical University,China National Clinical Research Center of Respiratory Diseases,National Center for Children’s Health,Beijing 100101,ChinaTuberculosis Research Center,Shanghai Public Health Clinical Center,Fudan University,Shanghai 200083,ChinaNational Clinical Research Center for Respiratory Diseases,National Key Discipline of Pediatrics,Capital Medical University,Key Laboratory of Major Diseases in Children,Ministry of Education,National Center for Children’s Health,Beijing Children’s Hospital,Beijing 100045,ChinaTuberculosis Research Center,Shanghai Public Health Clinical Center,Fudan University,Shanghai 200083,China Department of Infectious Diseases,Huashan Hospital,Fudan University,Shanghai 200040,ChinaTuberculosis Research Center,Shanghai Public Health Clinical Center,Fudan University,Shanghai 200083,China National Clinical Research Center for Infectious Diseases,Shenzhen Third People’s Hospital,Shenzhen 102206,Guangdong,China
医药卫生
Tuberculosis(TB)Tuberculosis infection(TBI)Creation tuberculin skin test(C-TST)Secreted antigenic target 6-kDa protein-culturefiltrate protein 10(ESAT6-CFP10)Skin testSerious adverse events(AEs)
《LabMed Discovery》 2025 (2)
P.1-6,6
supported by Anhui Longcom Biologic Pharmacy Co.Ltd.,ChinaThis study received grant support from the Clinical Research Project of Shanghai Public Health Clinical Center of China(No.KY-GW-2024-01)research start-up funds for introduced talents of Shanghai Public Health Clinical Center of China(No.RCJJ2025-08).
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