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- Title
Improved Performance of ELISA and Immunochromatographic Tests Using a New Chimeric A2-Based Protein for Human Visceral Leishmaniasis Diagnosis.
- Authors
Figueiredo, Maria Marta; dos Santos, Anna R. R.; Godoi, Lara C.; de Castro, Natália S.; de Andrade, Bruno C.; Sergio, Sarah A. R.; Jerônimo, Selma M. B.; de Oliveira, Edward J.; Valencia-Portillo, Ruth T.; Bezerra, Lucilândia M.; Goto, Hiro; Sanchez, Maria C. A.; Junqueira, Caroline; Teixeira, Santuza M. R.; da Fonseca, Flávio G.; Gazzinelli, Ricardo T.; Fernandes, Ana Paula
- Abstract
<bold>Methods: </bold>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).<bold>Conclusion: </bold>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.
- Subjects
CHIMERIC proteins; VISCERAL leishmaniasis; MIXED infections; AIDS patients; DIAGNOSIS; LEISHMANIASIS diagnosis; PROTEINS; IMMUNOGLOBULINS; LEISHMANIASIS; SERODIAGNOSIS; LIQUID chromatography; LEISHMANIA; ENZYME-linked immunosorbent assay; RECOMBINANT proteins; ANTIGENS
- Publication
Journal of Immunology Research, 2021, p1
- ISSN
2314-8861
- Publication type
journal article
- DOI
10.1155/2021/5568077