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

Prior treatment

• Receiving TB treatment for \>72 hours in previous 2 weeks

Other illness

• History of TB treatment in the last year
• Refusal to provide consent for study participation or HIV testing when status is unknown
• Severe illness resulting in unstable condition
• Absolute contra-indication to any of sampling procedures required by the study (ie: acute severe asthma, pertussis syndrome etc.)

Other

• Participants will be excluded (both from study groups) if:

• Pediatric Cohort
• \<8 years of age
• Identified with suspected PTB defined as follows:
  • A child with ≥1 of the following criteria:
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  • 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).
  • OR
  • 2\) Any duration of cough/ wheeze/ acute pneumonia with ≥1:
• 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.
  • Adult Cohort (WHO definition of a HIV-positive presumptive TB case)
• \> 15 years of age
• Confirmed HIV infection (ELISA or molecular)
• Presenting at any health facility with any of the following: cough, fever, night sweats or unintentional weight loss (any duration).