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A NOVEL POINT-OF-CARE TEST FOR LEPTOSPIROSIS BASED ON DUAL PATH PLATFORM (DPP) TECHNOLOGY TO DIFFERENTIATE IGM AND IGG ANTIBODY RESPONSES
Author
Affilliation
Chembio Diagnostic Systems. Medford, United States of America
Chembio Diagnostic Systems. Medford, United States of America
Duke University School of Medicine. Durham, United States of America
Duke University School of Medicine. Durham, United States of America
Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil / Universidade Federal da Bahia. Instituto de Saúde Coletiva. Salvador, BA, Brasil
Fundação Oswaldo Cruz. Bio-Manguinhos. Rio de Janeiro, RJ, Brasil
Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil
Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil / Yale University Schools of Public Health and Medicine. New Haven, United States of America
Chembio Diagnostic Systems. Medford, United States of America
Duke University School of Medicine. Durham, United States of America
Duke University School of Medicine. Durham, United States of America
Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil / Universidade Federal da Bahia. Instituto de Saúde Coletiva. Salvador, BA, Brasil
Fundação Oswaldo Cruz. Bio-Manguinhos. Rio de Janeiro, RJ, Brasil
Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil
Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil / Yale University Schools of Public Health and Medicine. New Haven, United States of America
Abstract
Introduction: Improved diagnostics for leptospirosis are urgently needed, especially for resource-poor
countries where leptospirosis is a major public health problem. The gold standard serodiagnostic test,
the microagglutination test or MAT, is complex, time-consuming, labor-intensive, and unavailable in
remote settings. Materials and Methods: A rapid (20 minutes) serodiagnostic test for leptospirosis was
developed using recombinant leptospiral immunoglobulin-like (Lig) protein fragments and a
modification of the Dual Path Platform (DPP) technology, namely dual DPP (D-DPP). The distinct feature
of this new immunoassay format was that the test detects separately IgM and IgG antibodies such that
each response can be measured semi-quantitatively by a reflectance reader device. The test was
evaluated in a pilot study using acute (n=91) and convalescent-phase (n=96) serum samples from
patients with confirmed leptospirosis and control individuals (n=50) from Brazil. Results: In this
evaluation study, the D-DPP assay detected 80% of patients with acute-phase leptospirosis and 100% of
patients with convalescent leptospirosis. The specificity was 100%. Among acute-phase cases, 60%
developed both detectable IgM and IgG antibodies, 13% had only IgM, while 7% produced only IgG
antibodies. During convalescence, 77%, 0%, and 23% of leptospirosis patients developed IgM and IgG,
only IgM, and only IgG antibodies, respectively. Conclusions: We designed a recombinant Lig proteinbased
D-DPP assay which can rapidly identify patients with acute-phase or convalescent leptospirosis
with high accuracy. The ability to detect IgM and IgG antibodies separately improves diagnostic
specificity as well as detection of patients who present at different times in the course of illness. The
test therefore has the potential to provide effective point-of-care diagnosis in field settings in Brazil and
resource-poor countries worldwide where leptospirosis is an emerging health problem
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