Leprosy Diagnostic Landscape

ML Flow Rapid Test (Anti-PGL-I)

An immunochromatographic strip assay for anti-PGL-I IgM using whole blood or serum, read visually within ten minutes. It has been evaluated extensively under field conditions in Brazil and Bangladesh. Since 2023 it has been made by Bioclin in Brazil as Bioclin Fast ML Flow Hanseníase, after technology transfer from the Federal University of Goiás, and supplied to the public health system.

Technology
Serology (Antibody) · Lateral flow
What it measures
IgM against ND-O-BSA (PGL-I mimetic)
Developer
KIT Biomedical Research, Royal Tropical Institute (Amsterdam, the Netherlands), with the Federal University of Goiás (Brazil)
Specimen
Capillary blood
Development status
Nationally registered with clinical validation
Regulatory status
National approval
Intended use
Field detection of anti-PGL-I response in contacts and suspected cases
Main limitation
Specificity is below the profile minimum, and the test is insensitive in paucibacillary disease.
Availability
Available. Made in Brazil by Bioclin (Quibasa Química Básica, Belo Horizonte) as Bioclin Fast ML Flow Hanseníase and listed on the FIND DxConnect Marketplace (checked 18 September 2026).
Linked publications
42
Manufacturers and partners
Bioclin, Quibasa Química Básica (Belo Horizonte, Brazil), Merck S.A. (Brazil)
TPP-1, confirming leprosy
62.5 of 100, partial alignment
TPP-2, infection in contacts
64.0 of 100, partial alignment
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