Diagnostic accuracy of tests using recombinant protein antigens of Mycobacterium leprae for leprosy: A systematic review

The aim of this systematic review was to investigate the studies that evaluated the sensitivity and specificity of serologic tests using recombinant protein antigens from Mycobacterium leprae for leprosy diagnosis. We included 13 studies that were available in PubMed, Brazilian Virtual Library of He...

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Bibliographic Details
Published in:Journal of infection and public health 2020-08, Vol.13 (8), p.1078-1088
Main Authors: de Oliveira, Ana Laura Grossi, Fraga, Vanêssa Gomes, Sernizon-Guimarães, Nathalia, Cardoso, Mariana Santos, Viana, Agostinho Gonçalves, Bueno, Lilian Lacerda, Bartholomeu, Daniella Castanheira, da Silva Menezes, Cristiane Alves, Fujiwara, Ricardo Toshio
Format: Article
Language:English
Subjects:
Antibodies, Bacterial - blood
Antigens, Bacterial - metabolism
Brazil
Colombia
Humans
Leprosy
Leprosy - diagnosis
Mycobacterium leprae
Mycobacterium leprae - immunology
Philippines
Recombinant protein antigens
Recombinant Proteins - metabolism
Reproducibility of Results
Sensitivity
Serologic Tests - standards
Serological tests
Specificity
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Summary:The aim of this systematic review was to investigate the studies that evaluated the sensitivity and specificity of serologic tests using recombinant protein antigens from Mycobacterium leprae for leprosy diagnosis. We included 13 studies that were available in PubMed, Brazilian Virtual Library of Health, Web of Science, ScienceDirect and Scopus. From these studies, we found that the recombinant serine-rich 45-kDa protein of M. leprae (ML0411) demonstrated high performance for multibacillary (MB) also to paucibacillary (PB) patients, although this study was tested only for Indian population. Despite that, studies using the ND-O-LID antigen have been able to more accurately identify new cases of leprosy among people living in endemic or non-endemic areas and household contacts in Brazil, Colombia, and the Philippines, especially when combined with other biomarkers. Finally, low sensitivity values for PB patients’ antibodies response remain challenging for tests intended to diagnose clinical forms that comprise this classification in leprosy.
ISSN:1876-0341
1876-035X
DOI:10.1016/j.jiph.2019.12.011