Assessing Diagnostics At Point-of-care for Tuberculosis

Prior treatment

• Have taken any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason, within 2 weeks of study entry (to reduce false-negatives);

Other

• Completed latent or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively);
• Reside \>20km from the study site or are unwilling to return for follow-up visits; OR
• Are unwilling to provide informed consent
  • Assessment of the usability of novel TB tests:
• The investigators will exclude staff who are:
• 1\) unwilling to provide informed consent

• The investigators will include non-hospitalized adults (age ≥ 12 years) with either:
• cough ≥2 weeks' duration, a commonly accepted criterion for identifying people with presumed pulmonary TB (to facilitate standardization across sites and comparison of test performance across sub-groups; OR
• risk factors for which TB screening is recommended (HIV infection, self-reported close contact, history of mining work). People with risk factors will be included if they screen positive for TB based on WHO-recommended screening tools as specified below:
  • Positive TB screening definitions by risk factor:
• People Living with Human Immunodeficiency Virus (PLHIV) (Risk Factor): C Reactive Protein (CRP) \>5 mg/dL OR abnormal chest x-ray (CXR)
• Self-reported Close Contact (Risk Factor): abnormal CXR History of mining work (Risk Factor): abnormal CXR
• The investigators will include health workers at each clinical site who are:
• aged ≥18 years; AND
• involved in routine TB testing (collecting specimens for or performing TB tests).

Criteria the registry did not label

• Novel TB triage and diagnostic tests: