Diagnostic accuracy of tuberculin-antigen skin test (TBST) (Cy-TB) for diagnosed TB infection in children

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250429001

Enrollment

300

Registered

2025-04-29

Start date

2025-11-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis in Children TB infection in children TBST (Tuberculin-antigen skin test) Cy-TB T-SPOT.TB

Interventions

Specimen Collection and Handling for T SPOT TB IGRA For T SPOT TB testing the research team will prepare the blood collection tubes in advance. If the participant is already scheduled for venipunctur

Active Comparator No treatment

Tuberculin-antigen skin test (TBST) (Cy-TB) for diagnosed TB infection in children

Eligibility

Sex/Gender

All

Age

No minimum to 18 Years

Inclusion criteria

Inclusion criteria: Volunteers must meet all of the following criteria to be eligible for participation in the study 1. Thai pediatric patients under 18 years of age 2. History of receiving BCG vaccination 3. Require screening for tuberculosis infection based on at least one of the following 3.1 Presenting with symptoms or clinical signs suggestive of tuberculosis, or 3.2 History of household or close contact with a patient with pulmonary or laryngeal tuberculosis 3.3 Planned to receive immunosuppressive therapy or chemotherapy 4. Written informed consent obtained voluntarily from the parent or legal guardian

Exclusion criteria

Exclusion criteria: Inability to undergo blood draw or intradermal injection

Design outcomes

Primary

Measure	Time frame
Sensitivity and specificity of Cy-TB at the 5-mm cut-point (overall, stratified into three predefined groups, and weighted estimates), with 95% confidence intervals 72 hr TBST,Positive predictive value (PPV) and negative predictive value (NPV) of Cy-TB at the 5-mm cut-point 72 hr TBST	—

Secondary

Measure	Time frame
Proportion of indeterminate/invalid results and associated factors. 3 days TBST,Sensitivity and specificity of Cy-TB at the 10-mm cut-point (overall, stratified into three predefined groups, and weighted estimates), with 95% confidence intervals (CIs) 3 days TBST,Comparison of sensitivity and specificity between groups (symptomatic, contacts, and immunosuppressed), age groups, and other relevant subgroups, with adjustment for multiple testing. 3 days TBST,Agreement between Cy-TB (at various cut-points) and T-SPOT.TB. 3 days TBST,Description of adverse events and injection-site reactions, reported as the number and percentage of participants affected. 3 days TBST	—

Measure

Time frame

Proportion of indeterminate/invalid results and associated factors. 3 days TBST,Sensitivity and specificity of Cy-TB at the 10-mm cut-point (overall, stratified into three predefined groups, and weighted estimates), with 95% confidence intervals (CIs) 3 days TBST,Comparison of sensitivity and specificity between groups (symptomatic, contacts, and immunosuppressed), age groups, and other relevant subgroups, with adjustment for multiple testing. 3 days TBST,Agreement between Cy-TB (at various cut-points) and T-SPOT.TB. 3 days TBST,Description of adverse events and injection-site reactions, reported as the number and percentage of participants affected. 3 days TBST

—

Countries

Thailand

Contacts

Public ContactChayapon Mangking

Faculty of Medicine, Chulalongkorn University

promchayapon@gmail.com022564930

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026