A Trial in Subjects Suspected to Have Tuberculosis, Comparing the Diagnostic Performance of C-Tb to QuantiFERON®, in Combination With a Safety Assessment of C-Tb Versus Tuberculin PPD RT23 SSI

Inclusion Criteria: HIV NEGATIVE PARTICIPANTS: 1. Participants between 5 and 65 years attending the TB clinic due to suspicion of TB disease 2. Infants, toddlers and children between 28 days and 4 years must either have symptoms or signs of TB or be in close contact to a smear positive pulmonary TB case (more than 6 hours/day for at least five days) 3. Is between 28 days and 65 years of age 4. Participant, parent or legal guardian has signed the informed consent 5. Is HIV negative confirmed by two rapid tests. However, children between 28 days and 4 years may have an unknown HIV status and may receive antiretroviral therapy (ART) or have breastfeeding mothers on ART 6. Is willing and likely to comply with the trial procedures 7. Is prepared to grant authorized persons access to their medical record HIV POSITIVE PARTICIPANTS: 1. Participants between 5 and 65 years attending the TB clinic due to suspicion of TB disease 2. Infants, toddlers and children between 28 days and 4 years must either have symptoms\* or signs\*\* of TB or be in close contact to a smear positive pulmonary TB case (more than 6 hours/day for at least five days) 3. Is between 28 days and 65 years of age 4. Participant, parent or legal guardian has signed the informed consent 5. Is HIV positive confirmed by: 1. two positive rapid tests or 2. 1 positive rapid test and an additional confirmatory ELISA test 6. A CD4 count has been done 7. Is willing and likely to comply with the trial procedures 8. Is prepared to grant authorized persons access to their medical record HIV NEGATIVE CONTROL GROUP: 1. Participant with no known contact to people infected with MTb and no signs or symptoms of TB. 2. Is between 5 and 11 years of age 3. Participant, parent or legal guardian has signed the informed consent 4. Is HIV negative confirmed by two rapid tests 5. Is willing and likely to comply with the trial procedures 6. Is prepared to grant authorized persons access to their medical record Exclusion Criteria: HIV NEGATIVE PARTICIPANTS: 1. Has a confirmed diagnosis of tuberculosis at Screening Visit 2. Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. MMR, yellow fever, oral typhoid vaccines) except BCG vaccine 3. Has been tuberculin (TST) tested less than 12 months prior to the day of inclusion 4. Is pregnant, breastfeeding or intending to get pregnant during the trial period 5. Is a female of child bearing potential (12 years of age or older) not willing to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptive measures during the trial period 6. Has an active disease affecting the lymphoid organs (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis) 7. Has a current skin condition which interferes with the reading of the C-Tb and PPD e.g. tattoos, severe scarring, burns/sunburns, rash, eczema, psoriasis, or any other skin disease at or near the injection sites 8. Has a condition where blood drawings pose more than minimal risk for the participant, such as haemophilia, other coagulation disorders or significantly impaired venous access 9. Currently participating in another clinical trial with an investigational or non-investigational drug or device or has participated in another clinical trial within the 3 months prior to dosing 10. Has participated in previous clinical trials investigating the ESAT-6 and/or CFP-10 antigens 11. Has a condition which in the opinion of the investigator is not suitable for participation in the trial HIV POSITIVE PARTICIPANTS: 1. Has a confirmed diagnosis of tuberculosis at Screening Visit 2. Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. MMR, yellow fever, oral typhoid vaccines) 3. Has been tuberculin (TST) tested less than 12 months prior to the day of inclusion 4. Is pregnant, breastfeeding or intending to get pregnant during the trial period 5. Is a female of child bearing potential (12 years of age or older) not willing to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptive measures during the trial period 6. Has an active disease affecting the lymphoid organs except for HIV (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis) 7. Has a known diagnosis of AIDS or is receiving antiviral therapy at the time of Screening Visit 8. Has a current skin condition which interferes with the reading of the C-Tb and PPD e.g. tattoos, severe scarring, burns/sunburns, rash, eczema, psoriasis, or any other skin disease at or near the injection sites 9. Has a condition where blood drawings pose more than minimal risk for the participant, such as haemophilia, other coagulation disorders or significantly impaired venous access 10. Currently participating in another clinical trial with an investigational or non-investigational drug or device or has participated in another clinical trial within the 3 months prior to dosing 11. Has participated in previous clinical trials investigating the ESAT-6 and/or CFP-10 antigens 12. Has a condition which in the opinion of the investigator is not suitable for participation in the trial HIV NEGATIVE CONTROL GROUP: 1. Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. MMR, yellow fever, oral typhoid vaccines) except BCG vaccine 2. Has been tuberculin (TST) tested less than 12 months prior to the day of inclusion 3. Has an active disease affecting the lymphoid organs (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis) 4. Has a current skin condition which interferes with the reading of the C-Tb and PPD e.g. tattoos, severe scarring, burns/sunburns, rash, eczema, psoriasis, or any other skin disease at or near the injection sites 5. Has a condition where blood drawings pose more than minimal risk for the participant, such as haemophilia, other coagulation disorders, or significantly impaired venous access 6. Currently participating in another clinical trial with an investigational or non-investigational drug or device, or has participated in another clinical trial within the 3 months prior to dosing 7. Has participated in previous clinical trials investigating the ESAT-6 and/or CFP-10 antigens 8. Has a condition which in the opinion of the investigator is not suitable for participation in the trial