摘要：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 withMycobacterium leprae, leprosy's etiologic agent. Since immunity againstM. lepraeis 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 againstM. lepraeacross the leprosy spectrum. The MBT thereby provides the basis for immunodiagnostic POC tests for leprosy with potential for other (infectious) diseases as well.Graphical AbstractDisplay OmittedHighlights•Prototype MBT that quantitatively detects six host-derived biomarkers is developed•The immunopathological spectrum of leprosy is ideally suited to evaluate the MBT•MBT discriminated patients with leprosy from controls in a high and non-endemic area•Application of the MBT using low invasive fingerstick blood is technically feasibleDiagnostic Technique in Health Technology; Applied Microbiology; Biotechnology
