C-TST

Operational Research of Recombinant Mycobacterium Tuberculosis Fusion Protein Tuberculin Skin Test (C-TST)

Information

This is an operational research study evaluating the use of an antigen-based skin test for tuberculosis (TB) infection, specifically the recombinant ESAT-6/CFP-10-based skin test (C-TST), among adult household and close contacts of patients with TB.

Anhui Zhifei Longcom Biopharmaceutical Co., Ltd
PT Jakarta Biopharmaceutical Industry (J-Bio)

Type of Study

Collabolator

Operational Research

Background

Tuberculosis (TB), caused by Mycobacterium tuberculosis, remains a major global health challenge, particularly in developing countries. Indonesia is among the countries with the highest TB burden worldwide. Household and close contacts of patients with TB are considered a priority population for TB prevention efforts due to their increased risk of TB infection and disease progression. Early detection of TB infection is therefore essential, yet many cases remain undiagnosed.

Current screening methods for latent TB infection (LTBI), including the tuberculin skin test (TST) and interferon-gamma release assay (IGRA), have limitations related to specificity, cost, and accessibility. In routine programmatic settings, LTBI screening tools need to balance diagnostic performance, feasibility of implementation, safety, and overall programmatic value. The World Health Organization has recognized antigen-based skin tests such as C-TST as acceptable tools for the diagnosis of TB infection. C-TST uses ESAT-6 and CFP-10 recombinant antigens and has demonstrated high sensitivity, improved specificity in Bacillus Calmette–Guérin (BCG)-vaccinated populations, and fewer adverse effects.

This operational research study aims to evaluate the implementation and use of C-TST for TB infection screening among adult household and close contacts of patients with TB in routine programmatic settings.