TPP: For a community-based triage/referral test for identification of tuberculosis suspects

Tuberculosis

Minimum/Acceptable: To develop a test that can be used during a patient's first encounter with the health-care system to identify patients with any symptoms of or risk factors for active pulmonary TB, including patients coinfected with HIV, those who do not have TB and those who need referral for further confirmatory testing. Preferred/Optimal/Ideal: To develop a test that can be used during a patient's first encounter with the health-care system to identify patients with any symptoms of or risk factors for active TB, including patients coinfected with HIV, those who do not have TB and those who need referral for further confirmatory testing.

Minimum/Acceptable: Adults and children with signs and symptoms of active pulmonary TB in countries with a medium prevalence to a high prevalence of TB as defined by WHO. Preferred/Optimal/Ideal: Adults and children with signs and symptoms of active TB at any site in countries with a medium prevalence to a high prevalence of TB as defined by WHO.

Minimum/Acceptable: Sputum; non-sputum samples are preferred (such as urine, oral mucosal transudates, saliva, exhaled air, or blood from a finger-stick; imaging technology. Preferred/Optimal/Ideal: Non-sputum samples (such as urine, oral mucosal transudates, saliva, exhaled air or blood from a finger-stick).

Minimum/Acceptable: Health posts and primary-care clinics or higher levels of the health-care system. Preferred/Optimal/Ideal: Community level or village level or higher levels of the health-care system.

Clinical sensitivity:: Minimum/Acceptable: Overall sensitivity should be >90% compared with the confirmatory test for pulmonary TB. Preferred/Optimal/Ideal: Overall sensitivity should be >95% when compared with the confirmatory test for pulmonary TB; no lower range of sensitivity was defined for extrapulmonary TB. Clinical specificity:: Minimum/Acceptable: Specificity should be >70% compared with the confirmatory test. Preferred/Optimal/Ideal: Specificity should be >80% compared with the confirmatory test. Time to results:: Minimum/Acceptable: <30 min. Preferred/Optimal/Ideal: <5 min.

ID_115