Xs02 (Sanroad)

Main study objectives 1) To evaluate the non-inferiority of the sensitivity of the test drug Xs02 to the control drug EC and QFT before skin test in patients with tuberculosis; 2) To evaluate the non-inferiority of the specificity of the test drug Xs02 to the control drug EC and QFT before skin test in healthy subjects and patients with other respiratory diseases other than tuberculosis; 3) To evaluate the negative rate of the BCG-vaccinated population in the triple-negative population aged 18-64 years old, which is better than the positive control TB-PPD. Secondary study objectives 1) To verify the positive reaction criteria of Xs02; 2) To evaluate the consistency of the skin test results of the test drug Xs02 and the control drug EC in patients with tuberculosis, healthy subjects and patients with other respiratory diseases other than tuberculosis, and the consistency with the QFT diagnostic results; 3) To compare the specificity of the test drug Xs02 and the control drug TB-PPD after skin test in healthy people aged 18-64 years old; 4) To evaluate the safety of the test drug Xs02 in people aged 3-64 years old.

To evaluate the safety and preliminary efficacy of intradermal injection of recombinant Mycobacterium tuberculosis fusion protein (EEC) in people aged 3-17 years and 66-75 years