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Quantitative lateral flow strip assays as User-Friendly Tools To Detect Biomarker Profiles For Leprosy
Anouk van Hooij1, Elisa M Tjon Kon Fat2, Renate Richardus3
1Dept. of Infectious Diseases, Leiden University Medical Center, The Netherlands.
Abstract:
Leprosy is a debilitating, infectious disease caused by Mycobacterium leprae. Despite the availability of multidrug therapy, transmission is unremitting. Thus, early identification of M. leprae infection is essential to reduce transmission. The immune response to M. leprae is determined by host genetics, resulting in paucibacillary (PB) and multibacillary (MB) leprosy associated with dominant cellular or humoral immunity, respectively. This spectral pathology of leprosy compels detection of immunity to M. leprae to be based on multiple, diverse biomarkers. In this study we have applied quantitative user friendly lateral flow assays (LFAs) for four immune markers (anti-PGL-I antibodies, IL-10, CCL4 and IP-10) for whole blood samples from a longitudinal BCG vaccination field-trial in Bangladesh. Different biomarker profiles, in contrast to single markers, distinguished M. leprae infected from non-infected test groups, patients from household contacts (HHC) and endemic controls (EC), or MB from PB patients. The test protocol presented in this study merging detection of innate, adaptive cellular as well as humoral immunity, thus provides a convenient tool to measure specific biomarker profiles for M. leprae infection and leprosy utilizing a field-friendly technology.
Insights
Early detection of Mycobacterium leprae infection is crucial for reducing leprosy transmission. This study introduces a user-friendly lateral flow assay measuring multiple immune markers, offering a convenient tool for identifying infection and disease types.
Area of Science:
- Immunology
- Infectious Diseases
- Biomarker Discovery
Background:
- Leprosy, caused by Mycobacterium leprae, remains a public health challenge due to persistent transmission despite multidrug therapy.
- Host genetics influence immune responses, leading to distinct paucibacillary (PB) and multibacillary (MB) leprosy forms.
- Accurate diagnosis and monitoring require assessing diverse immune markers reflecting both cellular and humoral immunity.
Purpose of the Study:
- To develop and validate a user-friendly diagnostic tool for early detection of Mycobacterium leprae infection.
- To evaluate the utility of a multi-biomarker approach for distinguishing leprosy infection and its forms.
- To assess immune responses in individuals participating in a BCG vaccination field trial.
Main Methods:
- Quantitative lateral flow assays (LFAs) were employed to measure four immune markers: anti-PGL-I antibodies, IL-10, CCL4, and IP-10.
- Whole blood samples from a longitudinal BCG vaccination field trial in Bangladesh were analyzed.
- The study compared biomarker profiles between infected and non-infected groups, patients and controls, and PB and MB leprosy patients.
Main Results:
- Biomarker profiles, unlike single markers, effectively differentiated M. leprae infected individuals from non-infected controls.
- Distinct biomarker signatures distinguished leprosy patients from household contacts (HHC) and endemic controls (EC).
- The assay successfully differentiated between multibacillary (MB) and paucibacillary (PB) leprosy patients.
Conclusions:
- A novel, field-friendly lateral flow assay integrating innate, adaptive cellular, and humoral immunity markers provides a convenient tool for M. leprae infection detection.
- Multi-biomarker profiling offers a superior approach to single markers for diagnosing leprosy and its subtypes.
- This technology has the potential to significantly improve early identification and management of leprosy, aiding transmission control efforts.
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