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. 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.