C-TST for Diagnosis of Latent Mycobacterium Tuberculosis Infection in Indonesia

This is an operational research in household/close contacts of confirmed TB patients to evaluate the effectiveness of C-TST compared to IGRA test in identifying latent TB cases using parameters of effectiveness and safety.

The study is designed as an operational research. After informed consent and screening by evaluation of medical history followed by thorough physical examination and vital signs test (body temperature, blood pressure, pulse rate, and respiration rate) and urine pregnancy test for women of childbearing potential, blood collection will be done in 300 eligible subjects for IGRA test, followed by C-TST skin test. Measure the body temperature of all subjects 30 min after the skin test. Test results will be observed with skin reaction at the injection site 48\~72 h after the skin test. Test results along with presence of adverse events until 7 days follow-up will be recorded. If there are discrepancies in the test result, a T-SPOT test will be conducted after the skin test.