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

Anouk van Hooij; Elisa M Tjon Kon Fat; Danielle de Jong; Marufa Khatun; Santosh Soren; Abu Sufian Chowdhury; Johan Chandra Roy; Khorshed Alam; Jong-Pill Kim; Jan Hendrik Richardus; Annemieke Geluk; Paul L A M Corstjens

doi:10.1016/j.isci.2020.102006

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

iScience. 2020 Dec 29;24(1):102006. doi: 10.1016/j.isci.2020.102006. eCollection 2021 Jan 22.

Affiliations

¹ Department of Infectious Diseases Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, the Netherlands.
² Department of Cell and Chemical Biology, Leiden University Medical Center, the Netherlands.
³ Rural Health Program, The Leprosy Mission International Bangladesh, Nilphamari, Bangladesh.
⁴ Institute for Leprosy Research, Korean Hansen Welfare Association, Gyeonggi-do, South Korea.
⁵ Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.

Abstract

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.

Keywords: Applied Microbiology; Biotechnology; Diagnostic Technique in Health Technology.