Abstract
SummaryTo end the decade-long, obstinately stagnant number of new leprosy cases, there is an urgent need for field-applicable diagnostic tools that detect infection with Mycobacterium leprae, leprosy's etiologic agent. Since immunity against M. leprae is characterized by humoral and cellular markers, we developed a lateral flow test measuring multiple host proteins based on six previously identified biomarkers for various leprosy phenotypes. This multi-biomarker test (MBT) demonstrated feasibility of quantitative detection of six host serum proteins simultaneously, jointly allowing discrimination of patients with multibacillary and paucibacillary leprosy from control individuals in high and low leprosy endemic areas. Pilot testing of fingerstick blood showed similar MBT performance in point-of-care (POC) settings as observed for plasma and serum. Thus, this newly developed prototype MBT measures six biomarkers covering immunity against M. leprae across the leprosy spectrum. The MBT thereby provides the basis for immunodiagnostic POC tests for leprosy with potential for other (infectious) diseases as well.
Highlights
For over a decade, the annual number of newly detected leprosy cases has stagnated around 200,000 including children (World Health Organisation, 2019)
To end the decade-long, obstinately stagnant number of new leprosy cases, there is an urgent need for field-applicable diagnostic tools that detect infection with Mycobacterium leprae, leprosy’s etiologic agent
Since immunity against M. leprae is characterized by humoral and cellular markers, we developed a lateral flow test measuring multiple host proteins based on six previously identified biomarkers for various leprosy phenotypes
Summary
The annual number of newly detected leprosy cases has stagnated around 200,000 including children (World Health Organisation, 2019). Implementation of diagnostic tests specific for M. leprae infection in contact and population surveys will allow the identification of M. leprae-infected individuals as target for post-exposure prophylaxis (PEP), as well as detection of early stage leprosy for timely treatment (Blok et al, 2018; GPZL, 2019). Such diagnostic tests are not yet available (GPZL, 2019; Smith et al, 2016). In order to implement novel tools in leprosy endemic areas, which are often resource-limited settings, diagnostic tests need to be available in a user- and field-friendly, rapid test format
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