ArticlePLoS neglected tropical diseases2022
Development and validation of a multiplex real-time qPCR assay using GMP-grade reagents for leprosy diagnosis.
Article in PLoS neglected tropical diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Who cites it
11 citing papers in PubMed, 17 citations in OpenAlex.
- Identification of Mycobacterium leprae and Mycobacterium lepromatosis Cases with Broad-Range Molecular Assays at a Single Large Reference Laboratory.The American journal of tropical medicine and hygiene · 2026Article
- Real-Time PCR-Based Detection ofJournal of tropical medicine · 2026Article
- Leprosy research updates: Shaping the future of global health.The Indian journal of medical research · 2025Article
- Comparison of an In-House Multiplex Real-Time PCR Method With Altona Diagnostics Kits in the Detection of HSV, VZV, and EBV Viruses in Transplant Patients.BioMed research international · 2025Article
- Leprosy.Nature reviews. Disease primers · 2024Review
- Validation of the performance of a point of care molecular test for leprosy: From a simplified DNA extraction protocol to a portable qPCR.PLoS neglected tropical diseases · 2024Article
- Diagnostic Utility of Multiplex Polymerase Chain Reaction in Patients of Clinically Suspected Pure Neuritic Leprosy by Identifying Mycobacterium leprae in Skin Biopsy Samples and Nasal Swabs.The American journal of tropical medicine and hygiene · 2024Article
- qPCR detection ofFrontiers in molecular biosciences · 2024Article
- Challenges and advances in serological and molecular tests to aid leprosy diagnosis.Experimental biology and medicine (Maywood, N.J.) · 2023Review
- Highly sensitive and rapid determination of Mycobacterium leprae based on real-time multiple cross displacement amplification.BMC microbiology · 2023Article
- Pathogenicity and virulence ofVirulence · 2022Review
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Authors and funding
14 authors at 5 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Leprosy is a chronic dermato-neurological disease caused by Mycobacterium leprae, an obligate intracellular bacterium. Timely detection is a challenge in leprosy diagnosis, relying on clinical examination and trained health professionals. Furthermore, adequate care and transmission control depend on early and reliable pathogen detection. Here, we describe a qPCR test for routine diagnosis of leprosy-suspected patients. The reaction simultaneously amplifies two specific Mycobacterium leprae targets (16S rRNA and RLEP), and the human 18S rRNA gene as internal control. The limit of detection was estimated to be 2.29 copies of the M. leprae genome. Analytical specificity was evaluated using a panel of 20 other skin pathogenic microorganisms and Mycobacteria, showing no cross-reactivity. Intra- and inter-operator Cp variation was evaluated using dilution curves of M. leprae DNA or a synthetic gene, and no significant difference was observed between three operators in two different laboratories. The multiplex assay was evaluated using 97 patient samples with clinical and histopathological leprosy confirmation, displaying high diagnostic sensitivity (91%) and specificity (100%). Validation tests in an independent panel of 50 samples confirmed sensitivity and specificity of 97% and 98%, respectively. Importantly, assay performance remained stable for at least five months. Our results show that the newly developed multiplex qPCR effectively and specifically detects M. leprae DNA in skin samples, contributing to an efficient diagnosis that expedites the appropriate treatment.
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