Evaluation of a rapid serological test for leprosy classification using human serum albumin as the antigen carrier

Moura, Rodrigo Scaliante de; Penna, Gerson Oliveira; Fujiwara, Tsuyoshi; Pontes, Maria Araci de Andrade; Cruz, Rossilene Conceição da Silva; Gonçalves, Heitor de Sá; Penna, Maria Lúcia Fernandes; Cardoso, Ludimila Paula Vaz; Stefani, Mariane Martins de Araújo; Bührer-Sékula, Samira

doi:10.1016/j.jim.2014.06.014

Cited by 15 publications

(14 citation statements)

References 37 publications

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“…Sensitivity and specificity found for each ELISA matched the accuracy reported by other authors [15, 43, 44, 49]. On the contrary, when we compared the performance reported in these studies with our results, there was no consensus regarding a superior antigen for leprosy ELISAs.…”

Section: Discussionsupporting

confidence: 81%

Accuracy of Enzyme-Linked Immunosorbent Assays (ELISAs) in Detecting Antibodies againstMycobacterium lepraein Leprosy Patients: A Systematic Review and Meta-Analysis

Espinosa

Ferreira

Longhi³

et al. 2018

Canadian Journal of Infectious Diseases and Medical Microbiolog

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IgM against Mycobacterium leprae may be detected by enzyme-linked immunosorbent assays (ELISAs) based on phenolic glycolipid I (PGL-I) or natural disaccharide octyl bovine serum albumin (ND-O-BSA) as antigens, and the IgG response can be detected by an ELISA based on lipid droplet protein 1 (LID-1). The titers of antibodies against these antigens vary with operational classification. The aim of this study was to compare the accuracy of ELISAs involving PGL-I and ND-O-BSA with that involving LID-1. We included studies that analyze multibacillary and paucibacillary leprosy cases and evaluate the diagnostic accuracy of ELISAs based on LID-1 and/or PGL-I or ND-O-BSA as antigens to measure antibody titers against M. leprae. Studies were found via PubMed, the Virtual Health Library Regional Portal, Literatura Latino-Americana e do Caribe em Ciências da Saúde, Índice Bibliográfico Espanhol de Ciências de Saúde, the Brazilian Society of Dermatology, National Institute for Health and Clinical Excellence, Cochrane Library, Embase (the Elsevier database), and Cumulative Index to Nursing and Allied Health Literature. The Quality Assessment of Diagnostic Accuracy Studies served as a methodological validity tool. Quantitative data were extracted using the Standards for Reporting of Diagnostic Accuracy. Sensitivity, specificity, and a diagnostic odds ratio were calculated, and a hierarchical summary receiver-operating characteristic curve and forest plots were constructed. The protocol register code for this meta-analysis is PROSPERO 2017: CRD42017055983. Nineteen studies were included. ND-O-BSA showed better overall performance in terms of sensitivity, specificity, positive and negative likelihood ratios, and diagnostic odds ratio when compared with PGL-I and LID-1. The multibacillary group showed better performance on these parameters (than the paucibacillary group did), at 94%, 99%, 129, 0.05, and 2293, respectively. LID-1 did not provide any advantage regarding the overall estimate of sensitivity in comparison with PGL-I or ND-O-BSA.

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Section: Discussionsupporting

confidence: 81%

Accuracy of Enzyme-Linked Immunosorbent Assays (ELISAs) in Detecting Antibodies againstMycobacterium lepraein Leprosy Patients: A Systematic Review and Meta-Analysis

Espinosa

Ferreira

Longhi³

et al. 2018

Canadian Journal of Infectious Diseases and Medical Microbiolog

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“…Both sensitivity and specificity were lower in the crosssectional designs, with a statistically significant difference in specificity (p 0.019) ( Table 2). Only 11 studies reported the use of manufactured serology kits [11,12,32,36,37,43,44,61,65,67,71] and only two of those used a cross-sectional design.…”

Section: Humoral Immune Response Evaluationmentioning

confidence: 99%

Diagnostic accuracy of tests for leprosy: a systematic review and meta-analysis

Gurung

Gomes

Vernal

et al. 2019

Clinical Microbiology and Infection

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Objectives: Owing to difficulties in the clinical diagnosis of leprosy, several complementary tests have been developed and used. The aim was to systematically summarize the accuracy of diagnostic tests for leprosy. Methods: We searched for relevant articles in Embase, Medline, and Global Health databases, until June 2017. Studies evaluating the accuracy of any diagnostic techniques for differentiating between people with and without leprosy were included. Studies solely focusing on differentiating between the separate forms of leprosy were excluded. Our protocol was registered on PROSPERO (CRD42017071803). We assessed study quality using the QUADAS-2 checklist. A bivariate random effects regression model was used for the meta-analyses. Results: We included 78 studies, most of those evaluating the detection of IgM antibodies against phenolic glycolipid I using ELISA. Sensitivity of the 39 studies evaluating ELISA was 63.8% (95% CI 55.0 e71.8); specificity 91.0% (95% CI 86.9e93.9). The lateral flow test (nine studies) and the agglutination test (five studies) had a slightly higher sensitivity and a slightly lower specificity. Sensitivity of qPCR was (five studies) 78.5% (95% CI 61.9e89.2) and specificity 89.3% (95% CI 61.4e97.8). Sensitivity of conventional PCR was (17 studies) 75.3% (95% CI 67.9e81.5) and specificity 94.5% (95% CI 91.4e96.5). Conclusions: Although the test accuracy looks reasonable, the studies suffered from heterogeneity and low methodological quality.

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“…These results are in agreement with another recent study comparing HSA and BSA as the antigen carriers. 6 A better understanding of the transmission, the epidemiology, and the features that lead to the development of leprosy is important to disease control. M. leprae infection is more prevalent than the disease, but subclinical infection and its role in transmission and disease development are not completely understood.…”

Section: Discussionmentioning

confidence: 99%

“…5 Both tests have been validated in previous studies. 4,6 Proportions and their 95% CIs were compared using the Pearson χ 2 test. The association between independent variables and the outcome (M. leprae infection or exposure) was measured using the odds ratio, and significance levels were established at.05.…”

Section: Methodsmentioning

confidence: 99%

Could Mycobacterium leprae Infection Be an Occupational Disease? A Survey in Healthcare Workers From an Endemic Area in the Amazonian Region

Pacheco

Bührer-Sékula

Moura

et al. 2015

Infect. Control Hosp. Epidemiol.

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Evaluation of a rapid serological test for leprosy classification using human serum albumin as the antigen carrier

Cited by 15 publications

References 37 publications

Accuracy of Enzyme-Linked Immunosorbent Assays (ELISAs) in Detecting Antibodies againstMycobacterium lepraein Leprosy Patients: A Systematic Review and Meta-Analysis

Accuracy of Enzyme-Linked Immunosorbent Assays (ELISAs) in Detecting Antibodies againstMycobacterium lepraein Leprosy Patients: A Systematic Review and Meta-Analysis

Diagnostic accuracy of tests for leprosy: a systematic review and meta-analysis

Could Mycobacterium leprae Infection Be an Occupational Disease? A Survey in Healthcare Workers From an Endemic Area in the Amazonian Region

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