ArticleInfectious diseases of poverty2024
Rapid test for Mycobacterium leprae infection: a practical tool for leprosy.
Article in Infectious diseases of poverty, 2024. 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.
- Performance of 2 Finger-Stick Blood Tests to Triage Adults With Symptoms of Pulmonary Tuberculosis: A Prospective Multisite Diagnostic Accuracy Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Trial
- Glycosylation profile ofiScience · 2026Article
- Seroprevalence ofThe Lancet regional health. Southeast Asia · 2026Article
- Diagnostic Role of Loop-Mediated Isothermal Amplification (LAMP) Assay in Nasal Swabs and Slit Skin Smear Specimens in Pediatric Leprosy: Correspondence.Indian journal of pediatrics · 2026Article
- Implementation of ML Flow for leprosy contacts in Brazil: Opportunities, pitfalls, and safeguards.PLoS neglected tropical diseases · 2026Review
- Biosensor-Based Platforms for the Detection and Screening ofACS infectious diseases · 2026Review
- Article
- Trained Immunity in Health and Disease.MedComm · 2025Review
- MoLEP-Co-creating a Mycobacterium leprae transmission interruption program for the Morogoro region, Tanzania.PLoS neglected tropical diseases · 2025Article
- Large-scale field application of a fingerstick blood test for Mycobacterium leprae infection: Monitoring population-wide effects of case finding and post-exposure prophylaxis on transmission in the Comoros and Madagascar.PLOS global public health · 2025Article
- Exploring the Neurological Manifestations of Leprosy: Clinical Insights and Implications.Cureus · 2025Review
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDetection of infection with Mycobacterium leprae allows timely prophylactic treatment, thereby reducing transmission as well as the risk of permanent, leprosy-associated nerve damage. However, since there is no worldwide-implemented standard test for M. leprae infection, detection of infection in asymptomatic individuals remains a major challenge for control programs in endemic areas. In previous studies, we developed and field-tested a lateral flow assay (LFA) quantitatively detecting human IgM against M. leprae-specific phenolic glycolipid I (anti-PGL-I), a marker for both active and past infection. This rapid test utilizes luminescent, background-free, up-converting reporter particles (UCP) and immunochromatography (i.e. the UCP-LF test platform) for accurate quantitation of anti-PGL-I IgM without operator bias. The aim of this study was to evaluate the final version of this quantitative UCP-based rapid test (i.e. PGL-I QURapid), using serum and fingerstick blood (FSB).
methodsThe test comprises a lateral flow strip, in a standard plastic or biodegradable cassette. It can be provided with a humanized, recombinant control to monitor test performance and calculate accurate anti-PGL-I IgM levels. The performance of this QUR-test was assessed using serum and FSB from patients with leprosy (n = 214), tuberculosis (n = 20), buruli ulcer (n = 19), leishmaniasis (n = 14), non-tuberculous mycobacterial (n = 35) infections, as well as healthy Dutch individuals (n = 710) and humanized, recombinant anti-PGL-I IgM antibodies. Plot receiver operating characteristic curves were created and sensitivity (Sn), specificity (Sp) and the area under the curve were calculated to evaluate test performance.
resultsTest results classified multibacillary leprosy patients with 95.0% Sn and 100% Sp using serum and 91.5% Sn and 99.8% Sp using FSB. Qualitative test results could be read after 2 min flow time, with accurate quantitation from 10 min onwards. The new anti-PGL-I IgM control supports production of batches with predetermined seropositivity thresholds and monitoring of the PGL-I QUR-test in various settings.
conclusionThe operational version of the PGL-I QURapid with point-of-care applicability, meets the WHO target product profile criteria. Thus, this QUR-test is ready for public health implementations.
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