Research priorities: Diagnostic tests
Country: Bolivia, Brazil
Status: Ongoing
Duration: May 2021 – April 2025

This project aims to identify means to

optimally implement POC diagnostic tests for leprosy and M. leprae infection in the South American Amazon.

Point-of-care immunodiagnostic tests for detection of leprosy and Mycobacterium leprae infection in high and low endemic areas in the South American Amazon

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Project summary

Stable new case detection rates of leprosy are witnessed among endemic populations in many of the countries where leprosy occurs. Contact with M. leprae infected individuals is a risk factor for the development of leprosy. To facilitate timely treatment as well as reduce transmission, it is vital to both early diagnose leprosy and identify M. leprae infected individuals lacking clinical symptoms. Active case finding by screening for clinical symptoms amongst individuals at highest risk of developing disease such as contacts of (former) leprosy patients, is a proven method to early detect disease. However, this still represents a substantial hurdle in present-day leprosy health care.

The research team has previously developed low complexity diagnostics tests (similar to a glucose dipstick or a pregnancy test) that can be performed by first line health care workers in the field to detect whether and to which extent an individual is infected with M. leprae by using 1 drop of fingerprick blood. This type of test is referred to as point-of-care (POC) as it can be performed in the field by first line health care workers and requires no complicated laboratory techniques. In addition, a more extensive version of this test allows quantitative detection of multiple components (called biomarkers) that together allow identification of various forms of leprosy in venous blood of people living Bangladesh. In this study the team proposes to apply 1) POCDxv1 (for quantitative detection of anti-PGL-I antibodies as a measure of infection in large scale screening efforts) and 2) Multi Biomarker Tests (MBT; for detection of biomarker profiles associated with leprosy or M. leprae infection).

The study population will be two distinct South American populations: a hyper-endemic, former leprosy colony, located at the north western outskirts of the Brazilian Amazon, and a lesser endemic population on the south eastern side of the Amazon in Bolivia. The team aim is to 1) assess whether both tests can be used to detect infection and identify leprosy in South American populations located in Brazil and Bolivia where leprosy still occurs, 2) evaluate the feasibility to implement these low complexity tests in leprosy health care in these areas, and 3) simultaneously increase clinical expertise with regard to leprosy by training health care staff to detect leprosy.

Co-financer: Turing Foundation

Budget: €305,484.00 | Project number: 709.21.10