TPP: Diagnostic test to confirm leprosy in individuals with clinical signs and symptoms
Target product profile for a diagnostic test to confirm leprosy in individuals with clinical signs and symptoms
23 July 2023
Indication
Leprosy diagnosis
Intended use
A laboratory-based test for the detection of analyte specific to M. leprae (and M. lepromatosis in ideal cases) for the purposes of providing confirmation (or elimination) of clinical leprosy.
Target population
All age groups.
Sample type and volume
Capillary blood from finger stick, venous blood draw, collected urine, nasal swab, slit skin smears (SSS) and punch biopsies if the punch biopsy format allows for sub-millimetre biopsies. Optimal sample volume of <100 uL.
Use setting
For a laboratory-based test, tests can be performed in a peripheral health facility/referral centre, primary care centres, tertiary care leprosy centres, regional or national diagnostic testing laboratory.
Safety
Normal use does not create any additional hazards to the operator when observing Universal Blood Safety/Body Fluid precautions.
Disease
Leprosy
Product type
Diagnostic
Status
Active