TPP: For a diagnostic tool to detect azithromycin resistance

To detect resistance to azithromycin in a patient with yaws.

Minimum/Acceptable: An in vitro laboratory-based test that detects T. pallidum-specific analyte(s) for the purpose of detecting azithromycin resistance in yaws patients with active or latent infection. Preferred/Optimal/Ideal: An in vitro point-of-care test that detects T. pallidum pertenue-specific analyte(s) for the purpose of detecting azithromycin resistance in yaws patients with active infection.

Minimum/Acceptable: All ages and gender of individuals (especially children) resident in the population living in the defined geographical area. Preferred/Optimal/Ideal: All ages and gender of individuals (especially children) resident in the population living in the defined geographical area.

Minimum/Acceptable: Dry swab of suspected yaws lesion. 1–100 uL Preferred/Optimal/Ideal: Finger-prick sample. 1–10 uL.

Minimum/Acceptable: For a laboratory-based test, tests can be performed in a peripheral health facility/referral centre, regional or national diagnostic testing laboratory. Preferred/Optimal/Ideal: The test will be performed under "zero-infrastructure" conditions in the field (including but not limited to schools, community health centres, households and outdoor conditions).

Clinical sensitivity:: Minimum/Acceptable: > 95% sensitivity. Preferred/Optimal/Ideal: > 99% sensitivity. Clinical specificity:: Minimum/Acceptable: > 95% specificity. Preferred/Optimal/Ideal: > 99% specificity. Time to results: Minimum/Acceptable: For a laboratory-based test, within a day. Preferred/Optimal/Ideal:: < 0.5 h to developed test result.

Stability and storage:: Minimum/Acceptable: Developed test result remains stable for 0.5 h. For laboratory-based tests, cold storage is acceptable for any laboratory-based testing components/consumables. Preferred/Optimal/Ideal: Developed test result remains stable for 24 h. For point-of-care tests, ambient storage conditions, 2–40 °C; no cold storage required.

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