Detection of Lipoarabinomannan in Urine Evaluation of the STANDARDTMF TBLAMFIA and Its Impact on the Initial TB Diagnosis
Evaluation of the performance of an in vitro test, the STANDARDTM F TB LAM Ag FIA (SD BIOSENSOR, INC.) for the early diagnosis of tuberculosis (TB) infection. This test is for in vitro professional diagnostic use and intended as an aid to early diagnosis of tuberculosis infection. The test will be used according to the instructions for use (IFU).
- EligibilityCriteria: Inclusion Criteria:  Inclusion criteria for PTB, PNTM and extraPTB:  Adult subjects with documented active pulmonary TB, pulmonary NTM or extrapulmonary TB Subjects who have signed informed consent Aged ≥18 years  Inclusion criteria for HC:  healthy donors who have signed informed consent aged ≥ 18 years no TB or NTM risk factors or exposure  Exclusion Criteria:  Exclusion criteria for PTB, PNTM and extraPTB:  Do not have active pulmonary TB, NTM or extrapulmonary TB Do not sign the informed consent Are aged < 18 years  Exclusion criteria for HC:  Have active pulmonary TB or NTM Do not sign the informed consent Are aged < 18 years - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Subjects attending the Infectious Diseases Ward of the participating centers with a pulmonary TB, pulmonary NTM or extrapulmonary TB. Healthy controls, - SamplingMethod: Probability Sample