Leprosy Diagnostic Landscape

Interferon-Gamma Release Assay (M. leprae-Specific Antigens)

Stimulation of whole blood or peripheral blood mononuclear cells with M. leprae-unique antigens, measuring interferon-gamma release. It detects cell-mediated responses, which are strongest in tuberculoid and paucibacillary disease.

Technology
Host Response · Cellular immunology
What it measures
IFN-γ response to ML89, ML2478, MLSA and related antigens
Developer
Academic groups, including Leiden University Medical Center (the Netherlands), the Federal University of Goiás and Fiocruz (Brazil)
Specimen
Venous blood
Development status
LDT with clinical validation
Regulatory status
None / RUO
Intended use
Detection of cell-mediated response to M. leprae in paucibacillary and tuberculoid disease
Main limitation
Cross-reacts with M. tuberculosis and BCG, and needs fresh, living lymphocytes.
Linked publications
45
Collaborating institutions
IDRI, now AAHI (Seattle, WA, USA), London School of Hygiene & Tropical Medicine (UK), Colorado State University (Fort Collins, CO, USA), Armauer Hansen Research Institute (Addis Ababa, Ethiopia)
TPP-1, confirming leprosy
25.5 of 100, low alignment
TPP-2, infection in contacts
16.5 of 100, low alignment
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