Serological Immunoassay for Hansen’s Disease Diagnosis and Monitoring Treatment: Anti-Mce1A Antibody Response Among Hansen’s Disease Patients and Their Household Contacts in Northeastern Brazil

Lima, Filipe Rocha; Filho, Fred Bernardes; Antunes, Vanderson Mayron Granemann; Santana, Jaci Maria; Almeida, Regina Coeli Palma de; Toro, Diana Mota; Bragagnollo, Vinicius Fozatti; Manso, Gabriel Martins da Costa; Paula, Natália Aparecida de; Alves, Eliracema Silva; Riley, Lee W.; Arruda, Sérgio; Frade, Marco Andrey Cipriani

doi:10.3389/fmed.2022.855787

Cited by 4 publications

(18 citation statements)

References 28 publications

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“…Indirect ELISA was used to measure the α-PGL-I IgM titer of every serum sample and the cut-off was based on the OD average among healthy subjects multiplied by 2.1 plus 10%, according to a previously reported protocol ( 7 , 12 , 15 ). Serology was performed with an ND-O-BSA (PGL-I)-based glycoconjugate of bovine serum albumin (NR-19346.…”

Section: Methodsmentioning

confidence: 99%

“…Quantitative evaluation of IgA, IgM, and IgG antibody α-Mce1A protein was performed by indirect ELISA according to a previously reported protocol ( 7 , 11 , 12 ). Purified recombinant Mce1A protein was provided by Dr. LW Riley (University of California, Berkeley, CA, USA).…”

Section: Methodsmentioning

confidence: 99%

“…The cut-off point was based on mean OD between healthy controls compared to samples from patients with HD. The OD data were analyzed by receiver operating characteristic (ROC) curves to determine the cut-off point highest and matched sensitivity, specificity, and likelihood ratio, as previously described ( 7 , 11 , 12 ). For all assays, negative control samples from healthy individuals with no history of diagnosis or contact with HD, positive samples for α-Mce1A antibodies from patients diagnosed with HD, and wells considered blank without the addition of specific antibodies and with peroxidase-linked second antibody for each immunoglobulin tested were added.…”

Section: Methodsmentioning

confidence: 99%

“…Mce1A is reported to mediate bacillus entry into cells in the host’s reticuloendothelial system cells and to induce their survival ( 9 , 10 ). Despite the presence of the Mce1A protein in the Mycobacterium genus, preliminary studies have shown that conditions such as bacillus Calmette-Guérin (BCG) vaccination and latent tuberculosis infection (LTBI) do not interfere with the levels of anti-Mce1A antibodies (α-Mce1A) in HD patients ( 11 , 12 ). Previously published studies have reported the potential of α-Mce1A antibodies for the detection and monitoring of HD, also indicating its role in the identification of asymptomatic contacts ( 11 , 12 ).…”

Section: Introductionmentioning

confidence: 99%

“…Despite the presence of the Mce1A protein in the Mycobacterium genus, preliminary studies have shown that conditions such as bacillus Calmette-Guérin (BCG) vaccination and latent tuberculosis infection (LTBI) do not interfere with the levels of anti-Mce1A antibodies (α-Mce1A) in HD patients ( 11 , 12 ). Previously published studies have reported the potential of α-Mce1A antibodies for the detection and monitoring of HD, also indicating its role in the identification of asymptomatic contacts ( 11 , 12 ). However, the present study is the first one carried out in a state of low endemicity in the Brazilian southeast, including patients with macular forms and mainly neurological signs and symptoms, representing the largest sample tested for the proposed serological assay.…”

Section: Introductionmentioning

confidence: 99%

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Serological testing for Hansen’s disease diagnosis: Clinical significance and performance of IgA, IgM, and IgG antibodies against Mce1A protein

et al. 2023

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Hansen’s disease (HD) is an infectious, treatable, and chronic disease. It is the main cause of infectious peripheral neuropathy. Due to the current limitations of laboratory tests for the diagnosis of HD, early identification of infected contacts is an important factor that would allow us to control the magnitude of this disease in terms of world public health. Thus, a cross-sectional study was conducted in the Brazilian southeast with the objective of evaluating humoral immunity and describing the accuracy of the immunoassay based on IgA, IgM, and IgG antibodies against surface protein Mce1A of Mycobacterium, the predictive potential of these molecules, the clinical significance of positivity, and the ability to segregate new HD cases (NC; n = 200), contacts (HHC; n = 105), and healthy endemic controls (HEC; n = 100) as compared to α-PGL-I serology. α-Mce1A levels for all tested antibodies were significantly higher in NC and HHC than in HEC (p < 0.0001). The performance of the assay using IgA and IgM antibodies was rated as highly accurate (AUC > 0.85) for screening HD patients. Among HD patients (NC), positivity was 77.5% for IgA α-Mce1A ELISA, 76.5% for IgM, and 61.5% for IgG, while α-PGL-I serology showed only 28.0% positivity. Multivariate PLS-DA showed two defined clusters for the HEC and NC groups [accuracy = 0.95 (SD = 0.008)] and the HEC and HHC groups [accuracy = 0.93 (SD = 0.011)]. IgA was the antibody most responsible for clustering HHC as compared to NC and HEC, evidencing its usefulness for host mucosal immunity and as an immunological marker in laboratory tests. IgM is the key antibody for the clustering of NC patients. Positive results with high antibody levels indicate priority for screening, new clinical and laboratory evaluations, and monitoring of contacts, mainly with antibody indexes ≥2.0. In light of recent developments, the incorporation of new diagnostic technologies permits to eliminate the main gaps in the laboratory diagnosis of HD, with the implementation of tools of greater sensitivity and accuracy while maintaining satisfactory specificity.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Serological testing for Hansen’s disease diagnosis: Clinical significance and performance of IgA, IgM, and IgG antibodies against Mce1A protein

et al. 2023

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An update of the diagnosis, treatment, and prevention of leprosy: A narrative review

Huang,

Su,

Chen

2024

Medicine

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Leprosy is an infectious disease that remains a public health concern. It is caused by acid-fast Bacillus leprae, which primarily affects the skin and peripheral nerves, potentially leading to long-term disability and stigma. However, current and previous efforts have focused on developing better diagnostic and therapeutic interventions for leprosy, and its prevention needs to be addressed. In this review, we organize the currently published papers and provide updates on the global epidemiology, diagnosis, treatment, and prevention of leprosy. Several online databases, including MEDLINE (National Library of Medicine, Bethesda, MD), PubMed, EMBASE, Web of Science, and Google Scholar, were searched to collect relevant published papers. As a public health issue, the World Health Organization set the goal of leprosy elimination with a prevalence of <1 case per 10,000 people, which was achieved in 2000 and in most countries by 2010, mainly owing to the treatment of leprosy using drugs starting in 1980 and no-cost access for patients since 1995. Although diagnostic and therapeutic techniques have improved, the new occurrence of leprosy remains a critical global disease burden. With continuous technological improvements in diagnosing and treating leprosy, obtaining more relevant healthcare knowledge and preventing leprosy disability are crucial.

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Anticorpos anti-Mce1A como biomarcadores sorológicos na hanseníase: diagnóstico, avaliação de contatos e seguimento

Lima¹

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in memoriam), meus genitores, com muito carinho, gratulação e alegria pelos incentivos, amor e parceria imensurável durante todos os anos de minha vida. AGRADECIMENTOS "If you want to go fast, go alone. If you want to go far, go together." Provérbio africano Agradeço inicialmente ao meu orientador Prof. Dr. Marco Andrey Cipriani Frade por oportunizar o meu ingresso no doutorado, por participar ativamente da minha formação como cientista e ser humano em constante desenvolvimento, pela amizade e dedicação em fazer a diferença na vida dos seus alunos, pacientes e na sociedade de forma geral. Assim como, por possibilitar a minha atuação nas ações para controle da hanseníase no Brasil e no desenvolvimento científico e tecnológico com impacto direto para população. Deixo registrado os meus agradecimentos a toda equipe do Laboratório de Cicatrização e Hanseníase, do Centro de Referência Nacional em Dermatologia Sanitária e Hanseníase, do ambulatório de dermatologia do HC-FMRP-USP e do Centro Saúde Escola Dr. Joel Domingos Machado (FMRP-USP) pelo apoio e por tornar viável a execução da minha tese. Agradeço aos amigos que fiz ao decorrer da minha trajetória científica, pois vocês foram fundamentais para suavizar todos esses anos dedicados à ciência. Agradeço ao Prof. Dr. Sérgio Arruda e toda equipe do Laboratório Avançado em Saúde Pública do Instituto Gonçalo Moniz da Fundação Oswaldo Cruz por me iniciar na jornada acadêmico-científica e possibilitar a minha consolidação nessa linha de pesquisa. Agradeço ao Prof. Dr. Lee Riley (in memoriam) da UC Berkeley pela sua constante colaboração. Como também, aos pacientes e profissionais envolvidos nesse trabalho.

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Serological Immunoassay for Hansen’s Disease Diagnosis and Monitoring Treatment: Anti-Mce1A Antibody Response Among Hansen’s Disease Patients and Their Household Contacts in Northeastern Brazil

Cited by 4 publications

References 28 publications

Serological testing for Hansen’s disease diagnosis: Clinical significance and performance of IgA, IgM, and IgG antibodies against Mce1A protein

Serological testing for Hansen’s disease diagnosis: Clinical significance and performance of IgA, IgM, and IgG antibodies against Mce1A protein

An update of the diagnosis, treatment, and prevention of leprosy: A narrative review

Anticorpos anti-Mce1A como biomarcadores sorológicos na hanseníase: diagnóstico, avaliação de contatos e seguimento

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