Every year, more than 3 million people with TB remain undiagnosed and 1 million die. Better diagnostics are essential to reducing the enormous burden of TB worldwide. The Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT) study seeks to reduce the burden of TB worldwide by evaluating faster, simpler, and less expensive TB triage and diagnostic tests.
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Eligibility Criteria
Novel TB triage and diagnostic tests:
Inclusion Criteria-
The investigators will include non-hospitalized adults (age ≥ 12 years) with either:
1. cough ≥2 weeks' duration, a commonly accepted criterion for identifying people with presumed pulmonary TB (to facilitate standardization across sites a…
Novel TB triage and diagnostic tests:
Inclusion Criteria-
The investigators will include non-hospitalized adults (age ≥ 12 years) with either:
1. 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
2. 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:
1. People Living with Human Immunodeficiency Virus (PLHIV) (Risk Factor): C Reactive Protein (CRP) \>5 mg/dL OR abnormal chest x-ray (CXR)
2. Self-reported Close Contact (Risk Factor): abnormal CXR History of mining work (Risk Factor): abnormal CXR
Exclusion Criteria-
1. Completed latent or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively);
2. Have taken any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason, within 2 weeks of study entry (to reduce false-negatives);
3. Reside \>20km from the study site or are unwilling to return for follow-up visits; OR
4. Are unwilling to provide informed consent
Assessment of the usability of novel TB tests:
Inclusion Criteria-
The investigators will include health workers at each clinical site who are:
1. aged ≥18 years; AND
2. involved in routine TB testing (collecting specimens for or performing TB tests).
Exclusion Criteria-
The investigators will exclude staff who are:
1\) unwilling to provide informed consent
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