TPP: For diagnostic test for surveillance of lymphatic filariasis
Diagnostic test for surveillance of lymphatic filariasis target product profile
Diagnostic test for surveillance of lymphatic filariasis
Minimum/Acceptable: An in vitro test for the detection of analyte(s) specific to Wuchereria bancrofti, Brugia malayi, or Brugia timori to aid in the surveillance of defined geographic areas as to whether recrudescence has/has not occurred. Preferred/Optimal/Ideal: An in vitro point-of-care test for the detection of analyte(s) specific to Wuchereria bancrofti, Brugia malayi, or Brugia timori to aid in the surveillance of defined geographic areas as to whether recrudescence has/has not occurred.
Minimum/Acceptable: All ages of individuals resident in the population living in the defined geographic area. Preferred/Optimal/Ideal: All ages of individuals resident in the population living in the defined geographic area.
Minimum/Acceptable: If a laboratory-based test is required, peripheral whole blood from finger stick, EDTA/heparinized sample, or DBS. No venepuncture sampling.1-100 μL. Preferred/Optimal/Ideal: Peripheral whole blood from finger stick.1-10 μL.
Minimum/Acceptable: If the required levels of performance necessitate a laboratory-based test, tests can be performed in a regional or national diagnostic testing laboratory. Preferred/Optimal/Ideal: The test will be performed in health facilities or under "zero-infrastructure" conditions including but not limited to community health centres, households, and outdoor conditions.
Clinical sensitivity:: Minimum/Acceptable: >85% sensitivity. Preferred/Optimal/Ideal: >99% sensitivity. Clinical specificity:: Minimum/Acceptable: >98.8% specificity. Preferred/Optimal/Ideal: >99.8% specificity. Time to results:: Minimum/Acceptable: If a laboratory test is required, <48 hours to developed test result. Preferred/Optimal/Ideal: <0.5 hour to developed test result.
Stability and storage:: Minimum/Acceptable: Developed test result remains stable for 0.5 hour. Target shelf-life/stability >=18 months, 4 C - 37 C; temperature excursion/prolonged deviation of 40 C for two weeks acceptable. If a laboratory-based test is required, cold storage is acceptable. Preferred/Optimal/Ideal: Developed test result remains stable for 24 hours. Target shelf-life/stability >=24 months, 4 C - 40 C, 50% RH (no cold chain required); temperature excursion/prolonged deviation of 50 C for two weeks acceptable. Ambient storage conditions, 4 C - 40 C; no cold storage required; colorimetric or other indicator of temperature deviation to indicate excessive heat/humidity exposure. It is recommended the indicator be placed inside the carton.
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