TPP: For point-of care tests for combined/mono syphilis infection

Syphilis

Minimum/Acceptable: Surveillance and case management; screening. Preferred/Optimal/Ideal: Surveillance and case management; screening.

Minimum/Acceptable: For surveillance and case management, sexually active population, including key populations (e.g. MSM, SW, STI-clinic/service attendees). For screening, pregnant women, key populations. Preferred/Optimal/Ideal: For surveillance and case management, sexually active population, including key populations (e.g. MSM, SW, STI-clinic/service attendees). For screening, pregnant women, key populations.

Minimum/Acceptable: Finger prick capillary blood (maximum 50 μL). Preferred/Optimal/Ideal: Finger prick capillary blood (maximum 20 μL) and oral fluids.

Minimum/Acceptable: Clinical and non-clinical, including community-based, settings. Preferred/Optimal/Ideal: Clinical and non-clinical, including community-based, settings. 

Clinical sensitivity:: Minimum/Acceptable: to detect treponema pallidum(TP), >80%; to detect non-TP-specific antibodies, >95% of high titre (>=1 in 8) specimens. Preferred/Optimal/Ideal: to detect TP, >90%; to detect non-TP-specific antibodies, >99% of high titre (>=1 in 8) specimens. Clinical specificity:: Minimum/Acceptable: to detect treponema pallidum(TP), >90%; to detect non-TP-specific antibodies, >90% of high titre (>=1 in 8) specimens. Preferred/Optimal/Ideal: to detect treponema pallidum(TP), >95%; to detect non-TP-antibodies, >95% of high titre (>=1 in 8) specimen. Time to results:: Minimum/Acceptable: <=30 minutes. Preferred/Optimal/Ideal: <=15 minutes.

Stability and storage:: Minimum/Acceptable: 12 months, stable between 2-35°C, 70% humidity, 3000m altitude. Preferred/Optimal/Ideal: 18 months, stable between 0-50°C, 90% humidity, 4500 m altitude.

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