Table 2.
Inclusion criteria | Exclusion criteria | |
---|---|---|
1 | At least one sputum sample tested positive for MTB by Xpert MTB/RIF assay in the study clinic/study laboratory or at least one sputum sample tested positive by culture methods in study laboratory or other TB laboratory | Anti-TB treatment in the last 6 monthsa |
2 | Be ≥18 years of age | Incapacity to produce and provide two sputum samples of sufficient volume and qualityb |
3 | Willing to provide a written consent or witnessed oral consent in the case of illiteracy for participation in the study, prior to patient’s first sample or other study-specific data being collected | Severe medical or psychiatric condition which in the opinion of the site investigator or designee, might interfere with the ability to give true informed consent and to adhere to the study requirements |
4 | Willing to be tested for HIV infection | Currently imprisoned |
5 | Agreeing to the collection and storage of blood, urine, and sputum specimens | Taking part in investigational product trials related to TB and/or lung diseases |
6 | Willing to start anti-TB treatment after TB diagnosis | |
7 | Living within the study area and willing to inform the study team of any change of address during the treatment and follow up period |
aTo ensure that no treatment failure are recruited into (immunological or genetic) marker studies
bTo ensure sufficient amount of sputum for host- and mycobacterial marker studies