Evaluating a New Stool Based qPCR for Diagnosis of Tuberculosis in Children and People Living With HIV

Inclusion criteria

• ✓. A child with ≥1 of the following criteria:
• ✓. Persistent unremitting cough (or cough significantly worse than usual in child with chronic lung disease including HIV-related) of \>2 weeks duration, unresponsive to a course of appropriate antibiotics (when clinically indicated)
• ✓. Poor growth documented over the preceding 3 months \[clear deviation from a previous growth trajectory and/or documented crossing of centile lines in the preceding 3 months and/or; weight-for-age, or weight-for-height Z-score of ≤2 in the absence of information on previous/recent growth trajectory AND not responding to nutritional rehabilitation (or to antiretroviral therapy if HIV-infected)\]
• ✓. Persistent unexplained lethargy or reduced playfulness/activity reported by the caregiver.
• ✓. Persistent (\>1w) unexplained fever (\>38C), reported by a guardian or objectively recorded at least once;
• ✓. In infants 0-60 days, also: unresponsive neonatal pneumonia or unexplained hepatosplenomegaly OR sepsis-like illness (all other more common causes excluded and/or not responding to appropriate therapy/ broad-spectrum antibiotics/antivirals).
• ✓. TB exposure. Either: i) Documented/Reported exposure to a known TB source case (regardless of smear status) in previous 12months OR ii) immunological evidence: positive IGRA or positive TST (defined as \>5mm in HIV infected or severely malnourished, \>10 otherwise)
• ✓. Chest radiograph suggestive of TB.