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Sustainable Development Goals
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DEVELOPMENT OF A NEW LATERAL FLOW ASSAY BASED ON IBMP-8.1 AND IBMP-8.4 CHIMERIC ANTIGENS TO DIAGNOSE CHAGAS DISEASE
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Fundação Oswalado Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.
Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.
Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.
Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.
Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.
Fundação Oswalado Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.
Fundação Oswalado Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.
Fundação Oswalado Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.
Federal University of Goiás. Center of Studies for Chagas Disease. Goiânia, GO, Brazil.
Fundação Oswaldo Cruz. Instituto Carlos Chagas. Curitiba, PR, Brasil / Molecular Biology Institute of Paraná. Curitiba, PR, Brazil.
Molecular Biology Institute of Paraná. Curitiba, PR, Brazil.
World Health Organization. Neglected Tropical Diseases. Chagas Disease Program. Geneva, Switzerland.
Fundação Oswaldo Cruz. Instituto Carlos Chagas. Curitiba, PR, Brasil
Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.
Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.
Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.
Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.
Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.
Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.
Fundação Oswalado Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.
Fundação Oswalado Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.
Fundação Oswalado Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.
Federal University of Goiás. Center of Studies for Chagas Disease. Goiânia, GO, Brazil.
Fundação Oswaldo Cruz. Instituto Carlos Chagas. Curitiba, PR, Brasil / Molecular Biology Institute of Paraná. Curitiba, PR, Brazil.
Molecular Biology Institute of Paraná. Curitiba, PR, Brazil.
World Health Organization. Neglected Tropical Diseases. Chagas Disease Program. Geneva, Switzerland.
Fundação Oswaldo Cruz. Instituto Carlos Chagas. Curitiba, PR, Brasil
Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.
Abstract
Despite several available methodologies for Chagas disease (CD) serological screening, the main limitation of chronic CD diagnosis
is the lack of effective tools for large-scale screening and point-of-care diagnosis to be used in different CD epidemiological
scenarios. Taking into account that developing such a diagnostic tool will significantly improve the ability to identify CD
carriers, we aimed at performing a proof-of-concept study (phase I study) to assess the use of these proteins in a point-of-care
platform using serum samples from different geographical settings of Brazil and distinct clinical presentations. The diagnostic
accuracy study was conducted on a panel of two WHO International Standards (IS) and 14 sera from T. cruzi-positive and 16
from T. cruzi-negative individuals. The results obtained with the test strips were converted to digital images, allowing
quantitative comparison expressed as a relative band intensity ratio (RBI). The diagnostic potential and performance were also
determined. Regardless of the geographical origin or clinical presentation, all sera with T. cruzi antibodies returned positive both
for IBMP-8.1 and IBMP-8.4 chimeric antigens. The area under the ROC curve (AUC) values was 100% for both antigens,
demonstrating an outstanding overall diagnostic accuracy (100%). Based on the data, we believe that the lateral flow assays
based on these antigens are promising methodologies for screening CD.
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