A Multiepitope‐Based Lateral Flow Assay for Leprosy Antibodies

Leprosy remains a significant global health concern, with over 200,000 new cases reported annually. Approximately 10% of patients already have grade 2 disabilities at diagnosis, highlighting the need for better early detection tools of the infection caused by Mycobacterium leprae . To address this, a lateral flow assay (LFA) is developed as a proof of concept for innovative leprosy diagnostics. The assay utilizes gold nanoparticles decorated with keyhole limpet hemocyanin bound to synthetic epitopes of M. leprae proteins. When leprosy antibodies are present in the sample, a stained dot appears as a result of the capture of antigen–antibody complex by an anti‐human antibody adsorbed to the strip. After being evaluated with clinical samples, the LFA demonstrates a sensitivity and specificity of 91.67 and 95.45%, respectively, even when samples with low antibody titers are assayed. Its simplicity, user‐friendliness, and low cost (US$0.10 per unit) associated with its rapid results render it a promising tool for implementation in public health programs, particularly in areas with limited resources. Given its performance, this assay can be a valuable asset for the diagnostic challenges posed by leprosy, contributing to its control and elimination efforts.