Improved Performance of ELISA and Immunochromatographic Tests Using a New Chimeric A2-Based Protein for Human Visceral Leishmaniasis Diagnosis
Summary. Human visceral leishmaniasis (VL) is a major public health problem worldwide, leading to significant mortality rates if not properly treated and controlled. Precise identification of infected patients is essential to establish treatment and control measures. Although several VL serological...
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2021-01-01
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| Series: | Journal of Immunology Research |
| Online Access: | http://dx.doi.org/10.1155/2021/5568077 |
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| author | Maria Marta Figueiredo Anna R. R. dos Santos Lara C. Godoi Natália S. de Castro Bruno C. de Andrade Sarah A. R. Sergio Selma M. B. Jerônimo Edward J. de Oliveira Ruth T. Valencia-Portillo Lucilândia M. Bezerra Hiro Goto Maria C. A. Sanchez Caroline Junqueira Santuza M. R. Teixeira Flávio G. da Fonseca Ricardo T. Gazzinelli Ana Paula Fernandes |
| author_facet | Maria Marta Figueiredo Anna R. R. dos Santos Lara C. Godoi Natália S. de Castro Bruno C. de Andrade Sarah A. R. Sergio Selma M. B. Jerônimo Edward J. de Oliveira Ruth T. Valencia-Portillo Lucilândia M. Bezerra Hiro Goto Maria C. A. Sanchez Caroline Junqueira Santuza M. R. Teixeira Flávio G. da Fonseca Ricardo T. Gazzinelli Ana Paula Fernandes |
| author_sort | Maria Marta Figueiredo |
| collection | DOAJ |
| description | Summary. Human visceral leishmaniasis (VL) is a major public health problem worldwide, leading to significant mortality rates if not properly treated and controlled. Precise identification of infected patients is essential to establish treatment and control measures. Although several VL serological diagnosis advances have been accomplished lately, mainly using recombinant antigens and immunochromatographic tests (ICTs), improvements may still be achieved using multiepitope chimeric proteins in different test platforms. Here, we reported on the evaluation of ELISA and an ICT developed with a new chimeric protein, named DTL-4, based on repetitive antigenic sequences, including those present in the A2 protein. Methods. A total of 1028 sera samples were used for the development and validation of ELISA (321 samples from L. infantum-infected patients, 62 samples from VL/AIDS coinfected patients, 236 samples from patients infected with other diseases, and 409 samples from healthy donors). A total of 520 sera samples were used to develop and validate ICT (249 samples from L. infantum-infected patients, 46 samples from VL/AIDS coinfected patients, 40 samples from patients infected with other diseases, and 185 samples from healthy donors). Findings. Using the validation sera panels, DTL-4-based ELISA displayed an overall sensitivity of 94.61% (95% CI: 89.94-97.28), a specificity of 99.41% (95% CI: 96.39-99.99), and an accuracy of 97.02% (95% CI: 94.61-98.38), while for ICT, sensitivity, specificity, and accuracy values corresponded to 91.98% (95% CI: 86.65-95.39), 100.00% (95% CI: 96.30-100.00), and 95.14% (95% CI: 91.62-97.15), respectively. When testing sera samples from VL/AIDS coinfected patients, DTL-4-ELISA displayed a sensitivity of 77.42% (95% CI: 65.48-86.16), a specificity of 99.41% (95% CI: 96.39-99.99), and an accuracy of 93.51% (95% CI: 89.49%-96.10%), while for DTL-4-ICT, sensitivity was 73.91% (95% CI: 59.74-84.40), specificity was 90.63% (95% CI: 81.02-95.63), and accuracy was 82.00% (95% CI: 73.63-90.91). Conclusion. DTL-4 is a promising candidate antigen for serodiagnosis of VL patients, including those with VL/AIDS coinfection, when incorporated into ELISA or ICT test formats. |
| format | Article |
| id | doaj-art-3bcab9f5ef29477e9bd8026fd5b59a34 |
| institution | Kabale University |
| issn | 2314-8861 2314-7156 |
| language | English |
| publishDate | 2021-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Immunology Research |
| spelling | doaj-art-3bcab9f5ef29477e9bd8026fd5b59a342025-02-03T01:25:41ZengWileyJournal of Immunology Research2314-88612314-71562021-01-01202110.1155/2021/55680775568077Improved Performance of ELISA and Immunochromatographic Tests Using a New Chimeric A2-Based Protein for Human Visceral Leishmaniasis DiagnosisMaria Marta Figueiredo0Anna R. R. dos Santos1Lara C. Godoi2Natália S. de Castro3Bruno C. de Andrade4Sarah A. R. Sergio5Selma M. B. Jerônimo6Edward J. de Oliveira7Ruth T. Valencia-Portillo8Lucilândia M. Bezerra9Hiro Goto10Maria C. A. Sanchez11Caroline Junqueira12Santuza M. R. Teixeira13Flávio G. da Fonseca14Ricardo T. Gazzinelli15Ana Paula Fernandes16Centro de Tecnologia em Vacinas da Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, BrazilDetechta Biotecnologia S.A, BrazilCentro de Tecnologia em Vacinas da Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, BrazilCentro de Tecnologia em Vacinas da Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, BrazilCentro de Tecnologia em Vacinas da Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, BrazilCentro de Tecnologia em Vacinas da Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, BrazilDepartamento de Bioquímica, Universidade Federal do Rio Grande do Norte, Natal, BrazilInstituto René Rachou, Fundação Oswaldo Cruz, Belo Horizonte, Minas Gerais, BrazilInstituto de Medicina Tropical da Faculdade de Medicina, Universidade de São Paulo, São Paulo, São Paulo, BrazilDepartamento de Pós-Graduação em Ciência Animal, Universidade Federal de Goiás, Goiânia, Goiás, BrazilInstituto de Medicina Tropical da Faculdade de Medicina, Universidade de São Paulo, São Paulo, São Paulo, BrazilInstituto de Medicina Tropical da Faculdade de Medicina, Universidade de São Paulo, São Paulo, São Paulo, BrazilCentro de Tecnologia em Vacinas da Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, BrazilCentro de Tecnologia em Vacinas da Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, BrazilCentro de Tecnologia em Vacinas da Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, BrazilCentro de Tecnologia em Vacinas da Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, BrazilCentro de Tecnologia em Vacinas da Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, BrazilSummary. Human visceral leishmaniasis (VL) is a major public health problem worldwide, leading to significant mortality rates if not properly treated and controlled. Precise identification of infected patients is essential to establish treatment and control measures. Although several VL serological diagnosis advances have been accomplished lately, mainly using recombinant antigens and immunochromatographic tests (ICTs), improvements may still be achieved using multiepitope chimeric proteins in different test platforms. Here, we reported on the evaluation of ELISA and an ICT developed with a new chimeric protein, named DTL-4, based on repetitive antigenic sequences, including those present in the A2 protein. Methods. A total of 1028 sera samples were used for the development and validation of ELISA (321 samples from L. infantum-infected patients, 62 samples from VL/AIDS coinfected patients, 236 samples from patients infected with other diseases, and 409 samples from healthy donors). A total of 520 sera samples were used to develop and validate ICT (249 samples from L. infantum-infected patients, 46 samples from VL/AIDS coinfected patients, 40 samples from patients infected with other diseases, and 185 samples from healthy donors). Findings. Using the validation sera panels, DTL-4-based ELISA displayed an overall sensitivity of 94.61% (95% CI: 89.94-97.28), a specificity of 99.41% (95% CI: 96.39-99.99), and an accuracy of 97.02% (95% CI: 94.61-98.38), while for ICT, sensitivity, specificity, and accuracy values corresponded to 91.98% (95% CI: 86.65-95.39), 100.00% (95% CI: 96.30-100.00), and 95.14% (95% CI: 91.62-97.15), respectively. When testing sera samples from VL/AIDS coinfected patients, DTL-4-ELISA displayed a sensitivity of 77.42% (95% CI: 65.48-86.16), a specificity of 99.41% (95% CI: 96.39-99.99), and an accuracy of 93.51% (95% CI: 89.49%-96.10%), while for DTL-4-ICT, sensitivity was 73.91% (95% CI: 59.74-84.40), specificity was 90.63% (95% CI: 81.02-95.63), and accuracy was 82.00% (95% CI: 73.63-90.91). Conclusion. DTL-4 is a promising candidate antigen for serodiagnosis of VL patients, including those with VL/AIDS coinfection, when incorporated into ELISA or ICT test formats.http://dx.doi.org/10.1155/2021/5568077 |
| spellingShingle | Maria Marta Figueiredo Anna R. R. dos Santos Lara C. Godoi Natália S. de Castro Bruno C. de Andrade Sarah A. R. Sergio Selma M. B. Jerônimo Edward J. de Oliveira Ruth T. Valencia-Portillo Lucilândia M. Bezerra Hiro Goto Maria C. A. Sanchez Caroline Junqueira Santuza M. R. Teixeira Flávio G. da Fonseca Ricardo T. Gazzinelli Ana Paula Fernandes Improved Performance of ELISA and Immunochromatographic Tests Using a New Chimeric A2-Based Protein for Human Visceral Leishmaniasis Diagnosis Journal of Immunology Research |
| title | Improved Performance of ELISA and Immunochromatographic Tests Using a New Chimeric A2-Based Protein for Human Visceral Leishmaniasis Diagnosis |
| title_full | Improved Performance of ELISA and Immunochromatographic Tests Using a New Chimeric A2-Based Protein for Human Visceral Leishmaniasis Diagnosis |
| title_fullStr | Improved Performance of ELISA and Immunochromatographic Tests Using a New Chimeric A2-Based Protein for Human Visceral Leishmaniasis Diagnosis |
| title_full_unstemmed | Improved Performance of ELISA and Immunochromatographic Tests Using a New Chimeric A2-Based Protein for Human Visceral Leishmaniasis Diagnosis |
| title_short | Improved Performance of ELISA and Immunochromatographic Tests Using a New Chimeric A2-Based Protein for Human Visceral Leishmaniasis Diagnosis |
| title_sort | improved performance of elisa and immunochromatographic tests using a new chimeric a2 based protein for human visceral leishmaniasis diagnosis |
| url | http://dx.doi.org/10.1155/2021/5568077 |
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