All 37 Shortlisted Diagnostics

An overview of 37 shortlisted diagnostic tests for leprosy, from clinical examination to genome sequencing. 33 detection tests are scored against the two WHO target product profiles, with links to 13,135 PubMed publications.

Antigen Detection

• MALDI-TOF Antigen and Immunoproteomic Profiling — Research laboratories, including the ICMR-National JALMA Institute (Agra, India) and Fiocruz with the University of Campinas (Brazil)
• Urinary M. leprae Antigen Detection — Academic groups

Clinical & Functional

• Clinical Diagnosis (WHO Cardinal Signs) — WHO programmatic standard
• Dermoscopy — Clinical practice
• High-Resolution Nerve Ultrasonography (HRUS) — In-house
• Monofilament Sensory Testing — Semmes–Weinstein monofilaments from several manufacturers, and in-house sets

Drug Resistance Testing

• GenoType LepraeDR (Line Probe Assay) — Hain Lifescience GmbH, a Bruker company (Nehren, Germany)
• Mouse Footpad Inoculation — A small number of reference laboratories, first described at the US Communicable Disease Center, now the CDC (Shepard, 1960)
• Sanger Sequencing of Drug Resistance-Determining Regions — Reference laboratories in the WHO sentinel surveillance network for antimicrobial resistance
• Targeted Deep Sequencing (Amplicon NGS) — Laboratory-developed tests used by reference laboratory networks

Host Response

• Circulating MicroRNA Signature — Academic groups, including the Instituto Lauro de Souza Lima and the Federal Universities of Minas Gerais and Pará (Brazil)
• Host Transcriptomic Signature (RNA) — Academic consortia, including Fiocruz (Brazil) and Leiden University Medical Center (the Netherlands)
• Interferon-Gamma Release Assay (M. leprae-Specific Antigens) — Academic groups, including Leiden University Medical Center (the Netherlands), the Federal University of Goiás and Fiocruz (Brazil)
• UCP-LFA Multi-Biomarker Signature (Antibody and Cytokine) — Leiden University Medical Center (LUMC), Leiden, the Netherlands

Image Analysis

• Automated Image Classification of Skin Lesions — Academic and digital health groups, including Fiocruz (Brazil), Tulane University (USA) and the World Health Organization

Microscopy & Histopathology

• Skin Biopsy Histopathology (H&E and Fite–Faraco) — In-house
• Slit-Skin Smear Microscopy (Ziehl–Neelsen) — In-house and national programmes

Molecular (NAAT)

• Biomeme Franklin Field qPCR (Lyophilised RLEP) — Biomeme Inc. (Philadelphia, PA, USA)
• CRISPR-Cas12/Cas13 Detection — Laboratory-developed (no single developer)
• Cartridge-Based Automated NAAT (GeneXpert and Truenat Class) — Molbio Diagnostics (Goa, India), for Truenat M. leprae
• Conventional PCR (RLEP and Other Targets) — Multiple laboratories
• Droplet Digital PCR (ddPCR) — Laboratory-developed assays, including those from the Shandong Provincial Institute of Dermatology and Venereology and Kunming Medical University (China)
• Environmental and Reservoir qPCR (Soil, Water, Armadillo and Squirrel) — Academic surveillance groups, including the National Hansen's Disease Program (USA), Leiden University Medical Center (the Netherlands) and the University of Edinburgh (UK)
• IBMP Kit Biomol Hanseníase (qPCR) — Instituto de Biologia Molecular do Paraná (IBMP) with Fiocruz (Instituto Oswaldo Cruz and Instituto Carlos Chagas), Brazil
• Loop-Mediated Isothermal Amplification (LAMP) — Multiple laboratories
• Multi-Target Multiplex qPCR (RLEP, 16S rRNA, sodA and hsp18) — Multiple laboratories
• Multiplex LAMP on Genie II (Leprosy and PKDL) — ICMR-National Institute of Pathology (New Delhi, India), run on the OptiGene Genie II (Horsham, UK)
• Nanopore Targeted and Whole-Genome Sequencing — Oxford Nanopore-based laboratory workflows
• Real-Time Quantitative PCR (qPCR) for RLEP and Other Targets — Multiple laboratories
• Recombinase Polymerase Amplification (RPA) — ICMR-National Institute of Research in Tribal Health (India)

Serology (Antibody)

• Anti-PGL-I ELISA (IgM) — Multiple laboratories
• Dried Blood Spot Serology — Academic groups and surveillance programmes
• LID-1 and NDO-LID ELISA — IDRI, now AAHI (Seattle, WA, USA)
• ML Flow Rapid Test (Anti-PGL-I) — KIT Biomedical Research, Royal Tropical Institute (Amsterdam, the Netherlands), with the Federal University of Goiás (Brazil)
• NDO-LID Rapid Test (OrangeLife and IDRI) — OrangeLife (Rio de Janeiro, Brazil) with IDRI, now AAHI (Seattle, WA, USA)
• OnSite Leprosy Ab Rapid Test — CTK Biotech (Poway, CA, USA)
• PGL-I QURapid (Quantitative Up-Converting Rapid Test) — Leiden University Medical Center (LUMC), Leiden, the Netherlands