TPP: For scabies diagnosis to start mass drug administration

To measure when there is evidence to support starting ivermectin-based mass drug administration.

Minimum/Acceptable: An in vitro laboratory-based test that detects S. scabiei-specific analyte(s) for the purpose of scabies mapping to identify areas with => 10% disease prevalence. Preferred/Optimal/Ideal: An in vitro point-of-care test that detects S. scabiei-specific analyte(s) for the purpose of "scabies mapping" to identify areas with ≥ 10% disease prevalence. 

Minimum/Acceptable: All ages of individuals resident in the population living in the defined geographical area. Preferred/Optimal/Ideal: All ages of individuals resident in the population living in the defined geographical area.

Minimum/Acceptable: Peripheral whole blood from finger stick, collected urine or skin swabs of a suspected area. 1–100 uL. Preferred/Optimal/Ideal: Peripheral whole blood from finger stick or collected urine. 1–10 μL.

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 including but not limited to schools, community health centers, households and outdoor conditions.

Clinical sensitivity:: Minimum/Acceptable: For initial clinical screen of Se=70%/Sp=70%, confirmatory test sensitivity: >= 93%. For initial clinical screen of Se=80%/Sp=80%, confirmatory test sensitivity: >=81%. Preferred/Optimal/Ideal: For initial clinical screen, single-test sensitivity: >=80%. Clinical specificity:: Minimum/Acceptable: For 1st clinical screen of Se=70%/Sp=70%, confirmatory test specificity: >=95%. For 1st clinical screen of Se=80%/Sp=80%, confirmatory test specificity: >= 93%. Preferred/Optimal/Ideal: For no initial clinical screen, single-test specificity: >=99%. Time to results:: Minimum/Acceptable: <2h to developed test result. Preferred/Optimal/Ideal: <0.5h 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 24h. Ambient storage conditions, 2–40 °C; no cold storage required.

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