Abstract
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.
Highlights
Human visceral leishmaniasis (VL) is one of the world’s most neglected diseases, largely affecting low-socioeconomic-level individuals, mainly in developing countries [1, 2, 3]
The results show that DTL-4, regardless of the diagnostic platform used, is a reliable and efficient antigen capable of detecting human VL cases with improved accuracy
The performance of the DTL-4 chimeric protein was evaluated for the development of kits for serological diagnosis, enzyme-linked immunosorbent assay (ELISA), and immunochromatographic tests (ICTs)
Summary
Human visceral leishmaniasis (VL) is one of the world’s most neglected diseases, largely affecting low-socioeconomic-level individuals, mainly in developing countries [1, 2, 3]. VL is fatal in 90%-100% of cases [4, 5]. According to the World Health Organization (WHO) estimates, 50,000 to 90,000 new VL cases occur each year worldwide [6]. The zoonotic VL caused by Leishmania (Leishmania) infantum occurs in Mediterranean countries (North Africa and Europe); Southeast Europe; Middle East; Central Asia; and North, Central, and South America (Mexico, Venezuela, Brazil, and Bolivia) [7]. The zoonotic VL transmission areas have expanded lately due to the migration of people from rural to urban areas [8]. In 2018, more than 95% of new VL cases occurred in Brazil and nine countries of Asia and Africa [6], and 90% of VL cases in America occurred in Brazil [4]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
