Tuberculin Skin Test (TST) is currently the standard test for latent tuberculosis (TB). Nevertheless, a drawback of this test is it may provide false positive results in participants who have received BCG vaccine. Interferon Gamma Release Assays (IGRA) have been used to overcome this limitation and could provide more a accurate result. However, the assay needs experienced operators and is costly, which limits its implementation. Mtb antigen-based skin tests (TBST) have recently been approved as
Conditions
Interventions
TST, C-Tb and C-TST,TST, C-Tb and C-TST,TST, C-Tb and C-TST
Active TB,Low risk TB,High risk TB
Sponsors
Health Systems Research Institute
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.1.1. For microbiologically-confirmed TB participants 1) Male or female subject aged 18-65 years or older. 2) Medically diagnosed with TB within the last 6 months (confirmed through cultures and/or molecular testing) and undergoing treatment with anti-tuberculosis agents. 3) Capable of comprehending (speaking, reading, and/or writing) Thai. 4) Capable of attending all study visits according to the study schedule. 5) Willing to provide written inform consent before any study procedures. 1.1.2. For participants with low risk of TB-infection 1) Male or female subject aged 18-65 years or older. 2) No history of contracting TB or contact with patients infected with TB. 3) Capable of comprehending (speaking, reading, and/or writing) Thai. 4) Capable of attending all study visits according to the study schedule. 5) Willing to provide written inform consent before any study procedures. 1.1.3. For participants with high risk of TB-infection 1) Male or female subject aged 18-65 years or older. 2) Living with pulmonary TB positive patients, in contact with TB positive patients >120 hours/month, or in contact with TB positive patients >8 hours in a single sitting. 3) Capable of comprehending (speaking, reading, and/or writing) Thai. 4) Capable of attending all study visits according to the study schedule. 5) Willing to provide written inform consent before any study procedures.
Exclusion criteria
Exclusion criteria: For microbiologically-confirmed TB participants 1) Immunodeficient; chemotherapy or immunosuppressant medication use within a year of screening (excludes HIV positive patients with CD4 more than 200 cells/mm3 and viral suppression at least 6 months prior to screening and enrollment). 2) TST at least 12 months prior to enrolling in the clinical trial 3) Pregnant or lactating (for biological female subjects) 4) History of skin disease(s), tattoos, or scarring in regions where the device(s) will be administered (potentially hindering their efficacy and interpretations of results). 1.2.2. For participants with low risk of TB-infection 1) Has a history of TB infection, manifestation of, or thoracic X-ray with TB-related symptoms. 2) Immunodeficient; chemotherapy or immunosuppressant medication use within a year of screening (excludes HIV positive patients with CD4 more than 200 cells/mm3 and viral suppression at least 6 months prior to screening and enrollment). 3) TST at least 12 months prior to enrolling in the clinical trial. 4) Pregnant or lactating (for biological female subjects). 5) History of skin disease(s), tattoos, or scarring in regions where the device(s) will be administered (potentially hindering their efficacy and interpretations of results). 1.2.3. For participants with high risk of TB-infection 1) Had a history of TB infection or manifestation of TB-related symptoms. 2) Immunodeficient; chemotherapy or immunosuppressant medication use within a year of screening (excludes HIV positive patients with CD4 more than 200 cells/mm3 and viral suppression at least 6 months prior to screening and enrollment). 3) TST at least 12 months prior to enrolling in the clinical trial. 4) Pregnant or lactating (for biological female subjects). 5) History of skin disease(s), tattoos, or scarring in regions where the device(s) will be administered (potentially hindering their efficacy and interpretations of results).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity, Specificity, and Likelihood ratios of C-Tb and C-TST with microbiologically-confirmed TB as standard. at 48-72 h after TB skin test Skin Assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity, Specificity, and Likelihood ratios of C-Tb and C-TST with IGRA as reference standard. at 48-72 h after TB skin test Skin Assessment,Reliability of the inter-observer variation to determine TB infection using each test. at 48-72 h after TB skin test Cohen's Kappa coefficient | — |
Countries
Thailand
Contacts
Public ContactAssist Prof. Phatharajit Phatharodom
Mahidol University
Outcome results
None listed