Seroreactivity to new Mycobacterium leprae protein antigens in different leprosy-endemic regions in Brazil

Hungria, Emerith Mayra; Oliveira, Reinaldo Cunha de; Souza, Ana Lúcia Osório Maroclo de; Costa, Maurício Barcelos; Souza, Vânia Niéto Brito de; Silva, Eliane Aparecida; Moreno, Fátima Regina Vilani; Nogueira, Maria Esther Salles; Costa, Maria Renata Sales Nogueira; Silva, Sônia Maria Usó Ruiz; Bührer-Sékula, Samira; Reed, Steven G.; Duthie, Malcolm S.; Stefani, Mariane Martins de Araújo

doi:10.1590/s0074-02762012000900017

Cited by 32 publications

(30 citation statements)

References 27 publications

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“…LID-1, a fusion of the ML0405 and ML2331 proteins, has proven to be strongly reactive with MB patients sera in many geographic locations [10,12-14]. Previous data have suggested that the addition of LID-1 protein to PGL-I could improve sensitivity in a diagnostic test, since some patients lacking anti-PGL-I antibodies have antibodies that recognize LID-1, and vice versa [12].…”

Section: Introductionmentioning

confidence: 99%

Development of a quantitative rapid diagnostic test for multibacillary leprosy using smart phone technology

Cardoso

Dias²,

Freitas

et al. 2013

BMC Infect Dis

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BackgroundDespite efforts to eliminate leprosy as public health problem, delayed diagnosis and disabilities still occur in many countries. Leprosy diagnosis remains based on clinical manifestations and the number of clinicians with expertise in leprosy diagnosis is in decline. We have developed a new immunochromatographic test with the goal of producing a simple and rapid system that can be used, with a minimal amount of training, to provide an objective and consistent diagnosis of multibacillary leprosy.MethodsThe test immobilizes two antigens that have been recognized as excellent candidates for serologic diagnosis (the PGL-I mimetic, ND-O, and LID-1), on a nitrocellulose membrane. This allows the detection of specific IgM and IgG antibodies within 20 minutes of the addition of patient sera. Furthermore, we coupled the NDO-LID® rapid tests with a new cell phone-based test reader platform (Smart Reader®) to provide objective interpretation that was both quantifiable and consistent.ResultsDirect comparison of serologic responses indicated that the rapid test detected a greater proportion of leprosy patients than a lab-based PGL-I ELISA. While positive responses were detected by PGL-I ELISA in 83.3% of multibacillary patients and 15.4% of paucibacillary patients, these numbers were increased to 87% and 21.2%, respectively, when a combination of the NDO-LID® test and Smart Reader® was used. Among multibacillary leprosy the sensitivity of NDO-LID® test assessed by Smart Reader® was 87% (95% CI, 79.2-92.7%) and the specificity was 96.1% (95% CI, 91.7- 98.6%). The positive predictive value and the negative predictive value of NDO-LID® tests were 94% (95% CI, 87.4-97.8%) and 91.4% (95% CI, 85.9-95.2%), respectively.ConclusionThe widespread provision of rapid diagnostic tests to facilitate the diagnosis or prognosis of multibacillary leprosy could impact on leprosy control programs by aiding early detection, directing appropriate treatment and potentially interrupting Mycobacterium leprae transmission.

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Section: Introductionmentioning

confidence: 99%

Development of a quantitative rapid diagnostic test for multibacillary leprosy using smart phone technology

Cardoso

Dias²,

Freitas

et al. 2013

BMC Infect Dis

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“…Using laboratory-based assays, our group and others have identified numerous native and recombinant proteins recognized by antibodies in MB leprosy patient serum (18)(19)(20)(21)(22)(23)(24)(25). One example is the chimeric fusion protein leprosy IDRI diagnostic 1 (LID-1), an antigen specifically recognized by sera from leprosy patients from geographically and ethnically diverse populations, with a direct correlation between seroreactivity and BI (18,(26)(27)(28). Complementary detection of antibodies against PGL-I or the components of LID-1 could lead to improved sensitivity within tests.…”

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confidence: 99%

Rapid Quantitative Serological Test for Detection of Infection with Mycobacterium leprae, the Causative Agent of Leprosy

Duthie

Balagon²,

Maghanoy³

et al. 2014

J Clin Microbiol

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Leprosy remains an important health problem in a number of regions. Early detection of infection, followed by effective treatment, is critical to reduce disease progression. New sensitive and specific tools for early detection of infection will be a critical component of an effective leprosy elimination campaign. Diagnosis is made by recognizing clinical signs and symptoms, but few clinicians are able to confidently identify these. Simple tests to facilitate referral to leprosy experts are not widely available, and the correct diagnosis of leprosy is often delayed. In this report, we evaluate the performance of a new leprosy serological test (NDO-LID). As expected, the test readily detected clinically confirmed samples from patients with multibacillary (MB) leprosy, and the rate of positive results declined with bacterial burden. NDO-LID detected larger proportions of MB and paucibacillary (PB) leprosy than the alternative, the Standard Diagnostics leprosy test (87.0% versus 81.7% and 32.3% versus 6.5%, respectively), while also demonstrating improved specificity (97.4% versus 90.4%). Coupled with a new cell phone-based test reader platform (Smart Reader), the NDO-LID test provided consistent, objective test interpretation that could facilitate wider use in nonspecialized settings. In addition, results obtained from sera at the time of diagnosis, versus at the end of treatment, indicated that the quantifiable nature of this system can also be used to monitor treatment efficacy. Taken together, these data indicate that the NDO-LID/Smart Reader system can assist in the diagnosis and monitoring of MB leprosy and can detect a significant number of earlier-stage infections. Despite advances toward the elimination of leprosy over the last 2 decades, new case detection rates have stabilized over the last decade and leprosy remains an important health problem in many regions (1). Like the number of registered cases, however, the number of clinicians who can reliably diagnose leprosy has waned, and delays in determining the correct diagnosis are common (2, 3). Efforts to develop and improve surveillance and referral systems appear necessary to achieve the early detection required to ensure that prompt and appropriate treatment can be provided to limit disabilities. The development of simple and practical tools to facilitate diagnosis would appear prudent.Currently, the diagnosis of leprosy is dependent on the appearance and recognition of clinical signs and symptoms. When skinsmear or pathology services are available, leprologists utilize the Ridley-Jopling scale to characterize five forms of the disease (4, 5). In practice, however, most field programs lack such services, and the clinical system suggested by WHO to classify individual patients and to select their treatment regimen is used (6). The WHO system uses skin lesions, bacterial positivity by skin smear, and the number of involved nerves to group leprosy patients into one of two simplified categories: multibacillary (MB) leprosy (patients are typically smear pos...

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“…This is a reasonable assumption given that substantial proportions of individuals in leprosy-endemic regions have antibody responses to PGL-I and that there are reports of individuals who have self-cured. Indeed, the accompanying article by Mariane Stefani's group (Hungria et al 2012) indicates that a slightly increased proportion of HHC are seropositive to M. leprae antigens in comparison to endemic controls. Seropositive but asymptomatic individuals may either (i) clear the infection, (ii) contain the infection at consistent levels or (iii) propagate M. leprae and ultimately produce clinical signs of leprosy.…”

Section: Discussionmentioning

confidence: 99%

The potential for vaccination in leprosy elimination: new tools for targeted interventions

Duthie

Saunderson

Reed

2012

Mem. Inst. Oswaldo Cruz

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Seroreactivity to new Mycobacterium leprae protein antigens in different leprosy-endemic regions in Brazil

Cited by 32 publications

References 27 publications

Development of a quantitative rapid diagnostic test for multibacillary leprosy using smart phone technology

Development of a quantitative rapid diagnostic test for multibacillary leprosy using smart phone technology

Rapid Quantitative Serological Test for Detection of Infection with Mycobacterium leprae, the Causative Agent of Leprosy

The potential for vaccination in leprosy elimination: new tools for targeted interventions

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