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.
Conclusions
This study demonstrates that C-TST is a reliable and safe diagnostic tool for detecting TBI in children and adolescents. It shows higher sensitivity than both T-SPOT.TB and the traditional TST, with no associated serious AEs. Therefore, C-TST is an effective and safe option for diagnosing TBI in this age group.
