Open AccessImproved Performance of ELISA and Immunochromatographic Tests Using a New Chimeric A2-Based Protein for Human Visceral Leishmaniasis Diagnosis
Author(s) -
María Marta Figueiredo,
Anna Raquel Ribeiro dos Santos,
Lara Carvalho Godói,
Natália Salazar de Castro,
Bruno C de Andrade,
Sarah Aparecida Rodrigues Sérgio,
Selma M. B. Jerônimo,
Edward Oliveira,
Ruth Tamara Valencia-Portillo,
Lucilândia Maria Bezerra,
Hiro Goto,
Maria Carmen Arroyo Sanchez,
Caroline Junqueira,
Santuza Maria Ribeiro Teixeira,
Flávio Guimarães da Fonseca,
Ricardo T. Gazzinelli,
Ana Paula Fernandes
Publication year - 2021
Publication title -
journal of immunology research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.315
H-Index - 83
eISSN - 2314-8861
pISSN - 2314-7156
DOI - 10.1155/2021/5568077
Subject(s) - visceral leishmaniasis , medicine , leishmania infantum , gastroenterology , leishmaniasis , immunology
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.