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 acc...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.展开更多
基金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).
文摘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.
