Prototype multi-biomarker test for point-of-care leprosy diagnostics

Area of Science:

• Immunology
• Infectious Diseases
• Medical Diagnostics

Background:

• Leprosy, caused by Mycobacterium leprae, has seen stagnant new case numbers for a decade.
• Effective diagnostic tools are needed for early detection and management of leprosy.
• Host immunity to M. leprae involves both humoral and cellular markers.

Purpose of the Study:

• To develop a field-applicable diagnostic tool for detecting Mycobacterium leprae infection.
• To create a multi-biomarker test (MBT) capable of measuring host protein levels associated with leprosy phenotypes.
• To assess the feasibility of quantitative detection of multiple biomarkers for leprosy diagnosis.

Main Methods:

• Developed a lateral flow test (MBT) to measure six specific host serum proteins.
• Utilized previously identified biomarkers associated with different leprosy phenotypes.
• Pilot tested the MBT using fingerstick blood samples for point-of-care (POC) application.

Main Results:

• The MBT successfully quantified six host serum proteins simultaneously.
• The test differentiated between multibacillary and paucibacillary leprosy patients and controls.
• Performance in POC settings using fingerstick blood was comparable to laboratory-based plasma and serum tests.

Conclusions:

• The prototype MBT effectively measures host immune responses to M. leprae across the leprosy spectrum.
• This multi-biomarker approach provides a foundation for developing immunodiagnostic POC tests for leprosy.
• The MBT technology holds potential for application in diagnosing other infectious diseases.