Reproducibility of rapid diagnostic tests for Trypanosoma cruzi infection in endemic areas of Colombia
Keywords:
Epidemiology, Chagas Disease, T. cruzi, Indigenous PopulationAbstract
Introduction: Chagas disease is a neglected tropical disease of interest to public health because of its social and economic burden. Identifying infected and sick people with Chagas disease constitutes the first step towards achieving World Health Ooganization’s goals for 2020.
Objective: To evaluate the reproducibility with gold standard of a rapid diagnostic test for detection of antibodies to T. cruzi; and to propose a diagnostic algorithm for Chagas disease under the point-of-care concept in an area with limited access to health care coverage.
Material and Methods: A cross-sectional study was performed to detect antibodies to T. cruzi in 151 indigenous volunteers belonging to three ethnic groups of the Sierra Nevada de Santa Marta, Colombia. Rapid tests-PDR SD BIOLINE Chagas Ab were implemented in the field versus confirmation in the laboratory using two standardized serological methods (ELISAs).
Results: The results show that 19,2 % seroreactivity for T. cruzi was found among the entire population screening. The highest rate of human infection with T. cruzi was detected in the Wiwa community. No significant differences between rapid diagnostic test and the standard techniques (ELISAs) were found. Sensitivity, specificity and concordance for RDT were 100 % (Kappa: 1,0).
Conclusions: The Sierra Nevada de Santa Marta continues to be a hyperendemic area for Chagas disease. The area is difficult to access and has low or no primary health care coverage, making the assessed rapid diagnostic test a useful tool for screening programs and defining treatment and control plans, which represents the first approach at establishing a point-of-care testing strategy for endemic countries for Chagas disease.
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References
1. Chagas C. Nova tripanozomiaze humana: estudos sobre a morfolojia e o ciclo evolutivo do Schizotrypanum cruzi n. gen., n. sp., ajente etiolojico de nova entidade morbida do homem. Memórias do Instituto Oswaldo Cruz [Internet].1909 [Cited 01/11/2020];1(2):159-218. Available from: https://cutt.ly/VftKSqP
2. Pérez Molina JA, Molina I. Chagas disease. Lancet [Internet]. 2018 [Cited 03/11/2019];391(10115):82-94. Available from: https://cutt.ly/TftLrQw
3. World Health Organization. Neglected tropical diseases [Internet]. Geneva: WHO; 2017 [Cited 01/11/2020]. Available from: https://www.who.int/neglected_diseases/diseases/en/
4. Filigheddu M, Górgolas M, Ramos J. Enfermedad de Chagas de transmisión oral. Medicina Clínica [Internet]. 2017 [Cited 11/11/2020];148(3):125-31. Available from: https://cutt.ly/ZzzVceU
5. Carlier Y, Altcheh J, Angheben A, Freilij H, Luquetti AO, Schijman AG, et al. Enfermedad congénita de Chagas: Recomendaciones actualizadas para la prevención, diagnóstico, tratamiento y seguimiento de recién nacidos y hermanos, niñas, mujeres en edad fértil y mujeres embarazadas. PLoS Negl Trop Dis [Internet]. 2019 [Cited 11/11/2020];13(10):e0007694. Available from: https://cutt.ly/vzxpkoh
6. Rojo J, Ruiz C, Salazar P. Enfermedad de Chagas en México. Gaceta Médica de México [Internet]. 2018 [Cited 18/11/2020];154(5):605-12. Available from: https://pubmed.ncbi.nlm.nih.gov/30407465/
7. World Health Organization. Sustaining the drive to overcome the global impact of neglected tropical diseases. Second WHO report on neglected tropical diseases [Internet]. Geneva: WHO; 2013 [Cited 21/11/2020]. Available from: https://cutt.ly/Pfuy4OX
8. Tarleton R, Gürtler R, Urbina J, Ramsey J, Viotti R. Chagas Disease and the London Declaration on Neglected Tropical Diseases. PLoS Neglected Tropical Diseases [Internet]. 2014 [Cited 21/11/2020];8(10):e3219 . Available from: https://cutt.ly/kfuyYvv
9. Pereira M, Bolger A, Marin J. Chagas Cardiomyopathy: An Update of Current Clinical Knowledge and Management: A Scientific Statement From the American Heart Association. AHA journal [Internet]. 2018 [Cited 01/12/2020];138(12):169-209. Available from: https://cutt.ly/ffuuq6O
10. World Health Organization. Weekly epidemiological record = Relevé épidémiologique hebdomadaire. Weekly Epidemiological Record [Internet]. 2015 [Cited 16/10/2021];6(90):33-44. 2015. Available from: https://cutt.ly/TfuutzH
11. Mejia A, Agudelo L, Dib J, Ortiz S, Solari A, Triana O. Genotyping of Trypanosoma cruzi in a hyper-endemic area of Colombia reveals an overlap among domestic and sylvatic cycles of Chagas disease. Parasites Vectors [Internet]. 2014 [Cited 16/10/2021];7:108. Available from: https://cutt.ly/eRpFIvm
12. Cucunuba Z, Manne J, Diaz D, Nouvellet P, Bernal O, Marchiol A, et al. How universal is coverage and access to diagnosis and treatment for Chagas disease in Colombia? A health systems analysis. Social Science Medicine [Internet]. 2017 [Cited 02/12/2020];175:187-98. Available from: https://cutt.ly/Kfuuua6
13. Organización Panamericana de la Salud. Enfermedad de Chagas en las comunidades indígenas De La Sierra Nevada de Santa Marta [Internet]. Washington: Organización Panamericana de la Salud; 2011 [Cited 13/12/2020]. Available from: https://cutt.ly/4fuupDA
14. Olivera M, Villamil J, Gahona C, Hernández J. Barriers to diagnosis access for chagas disease in Colombia. Journal Parasitology Research [Internet]. 2018 [Cited 13/12/2020]:594796. Available from: https://cutt.ly/hfuuIh3
15. Angheben A, Staffolani S, Anselmi M, Tais S, Degani M, Gobbi F, et al. Accuracy of a Rapid Diagnostic Test (Cypress Chagas Quick Test® ) for the Diagnosis of Chronic Chagas Disease in a Nonendemic Area: A Retrospective Longitudinal Study. Am J Trop Med Hyg [Internet]. 2017 [Cited 11/12/2020]; 97(5):1486-8. Available from: https://cutt.ly/wzxKesF
16. Olivera M, Chaverra K. New Diagnostic Algorithm for Chagas Disease: Impact on Access to Diagnosis and Out-of-Pocket Expenditures in Colombia. Iran Journal Public Health [Internet]. 2019 [Cited 05/12/2020];48(7):1379-81. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6708550/
17. Florez A, Caicedo R. Guía para la vigilancia por laboratorio del Trypanosoma cruzi [Internet]. Colombia: Instituto Nacional de Salud; 2017 [Cited 22/12/2020]. Available from: https://cutt.ly/bfuuXHJ
18. World Health Organization. Chagas disease in Latin America: an epidemiological update based on 2010 estimates. Weekly Epidemiological Record. [Internet]. 2015 [Cited 22/12/2020];90(06):33-44. Available from: https://cutt.ly/Rfuu15p
19. Castellanos Y, Cucunubá Z, Flórez A, Orozco L. Reproducibilidad de pruebas serológicas para el diagnóstico de infección por Trypanosoma cruzi en mujeres embarazadas de una zona endémica de Santander, Colombia. Biomédica [Internet]. 2014 [Cited 16/12/2020];34(2):198-206. Available from: https://revistabiomedica.org/index.php/biomedica/article/view/1571
20. Parra Henao G, Oliveros H, Hotez PJ, Motoa G, Franco Paredes C, Henao Martínez AF. In Search of Congenital Chagas Disease in the Sierra Nevada de Santa Marta, Colombia. Am J Trop Med Hyg [Internet]. 2019 [Cited 23/12/2020];101(3):482-3. Available from: https://cutt.ly/hzx68Ew
21. Valencia C, Caicedo A, Escribano D, Quintero H, Dib J. Programa piloto de control de la enfermedad de Chagas en comunidades indígenas de la Sierra Nevada de Santa Marta, Colombia. Biomédica [Internet]. 2015 [Cited 15/12/2020];35(4):180. Available from: https://cutt.ly/vfuifsv
22. Winner-Lab. Chagas ELISA Lisado. Ensayo inmunoenzimático (ELISA) para la detección de anticuerpos anti-Trypanosoma cruzi [Internet]. Argentina: Winner-Lab; 2000 [Cited 15/12/2020]. Available from: https://cutt.ly/MfuiNgC
23. Winner-Lab. Chagas ELISA Recombinante v 4.0. Ensayo inmunoenzimático (ELISA) para la detección de anticuerpos anti-Trypanosoma cruzi [Internet]. Argentina: Winner-Lab; 2000 [Cited 15/12/2020]. Available from: https://cutt.ly/afui27Q
24. Ministerio de Salud y Protección Social. Resolución N° 8430 de 1993 [Internet]. Colombia: Ministerio de Salud y Protección Social; 1993 [Cited 15/12/2020]. Available from: https://cutt.ly/tfuoudZ
25. Organización Mundial de la Salud. Declaración de Helsinki sobre Salud en Todas las Políticas. Conferencia Mundial de Promoción de la Salud [Internet]. Genova: Organización Mundial de la Salud Organización Mundial de la Salud; 2015 [Cited 15/12/2020]. Available from: https://cutt.ly/Bfupqo3
26. Suaescún S, Salamanca L, Pinazo M, Gil Ll. Sensitivity and Specificity of two rapid tests for the diagnosis of infection by Trypanosoma cruzi in a Colombian population. Plos Neglected Tropical Disease [Internet]. 2021 [Cited 15/10/2021]; 48(8):2948-52. Available from: https://doi.org/10.1371/journal.pntd.0009483
27. Cucunubá Z, Nouvellet P, Conteh L, Vera M, Angulo V, Dib J, et al. Modelling historical changes in the force-of-infection of Chagas disease to inform control and elimination programmes: Application in Colombia. BMJ Global Health [Internet]. 2017 [Cited 25/11/2019];2:[Aprox. 2p.]. Available from: https://cutt.ly/ffuplmk
28. Ríos L, Crespo J, Zapata M. Ethno-Methodology to Comprehension and Management of Chagas Disease in Wiwa Indigenous Communities Placed in South-Eastern Slope From Sierra Nevada de Santa Marta, Colombia . Saude e Sociedade [Internet]. 2012 [Cited 22/12/2020];21(2):446-57. Available from: https://cutt.ly/ufupxF1
29. Chappuis F, Mauris A, Holst M, Albajar P, Jannin J, Luquetti A, et al. Validation of a Rapid Immunochromatographic Assay for Diagnosis of Trypanosoma cruzi Infection among Latin-American Migrants in Geneva, Switzerland. J Clin Microbiol [Internet]. 2010 [Cited 25/11/2019];48(8):2948-52. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2916554/
30. Cantillo O, Medina M, Zuluaga S, Valverde C, Motta C, Ladino A, et al. Eco-epidemiological study reveals the importance of Triatoma dimidiata in the Trypanosoma cruzi transmission, in a municipality certified without transmission by Rhodnius prolixus in Colombia. Acta Tropica [Internet]. 2020 [Cited 10/12/2020]; 209:105550. Available from: https://doi.org/10.1016/j.actatropica.2020.105550
31. Cantillo O, Bedoya S, Xavier S, Zuluaga S, Salazar B, Vélez A, et al. Trypanosoma cruzi infection in domestic and synanthropic mammals such as potential risk of sylvatic transmission in a rural area from north of Antioquia, Colombia. Parasite Epidemiology Control [Internet]. 2020 [Cited 10/01/2021]; 11(52):e00171. Available from: https://doi.org/10.1016/j.parepi.2020.e00171
32. Parra G, Cardona A, Quirós O, Angulo V, Alexander N. House-level risk factors for Triatoma dimidiata infestation in Colombia. American Journal Tropical Medicine Hygiene [Internet]. 2015 [Cited 11/11/2020];92(1):193-200. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4347379/
33. Sánchez C, Albajar P, Wilkins P, Nieto J, Leiby D, Paris L, et al. Comparative Evaluation of 11 Commercialized Rapid Diagnostic Tests for Detecting Trypanosoma cruzi Antibodies in Serum Banks in Areas of Endemicity and Nonendemicity. J Clin Microbiol [Internet]. 2014 [Cited 13/12/2020];52(7):2506-12 Available from: https://cutt.ly/xfupILM
34. Ji M, Noh J, Cho B, Cho Y, Kim S, Yoon B. Evaluation of SD BIOLINE Chagas Ab Rapid kit. Korean Journal Laboratory Medicine [Internet]. 2009 [Cited 11/12/2020]; 29(1):48-52. Available from: https://cutt.ly/OfupAoR
35. Lorca M, Contreras M, Salinas P, Guerra A, Raychaudhuri S. Evaluación de una prueba rápida para el diagnóstico de la infección por Trypanosoma cruzi en suero. Parasitol Latinoam [Internet]. 2008 [Cited 15/12/2020];63(1):29-33. Available from: https://cutt.ly/oRCsFMw
36. Cucunubá Z, Valencia C, Puerta C, Sosa S, Torrico F, Cortés J, et al. Primer consenso colombiano sobre Chagas congénito y orientación clínica a mujeres en edad fértil con diagnóstico de Chagas. Infectio [Internet]. 2014 [Cited 15/12/2020];18(2):50-65. Available from: http://dx.doi.org/10.1016/j.infect.2013.12.001
37. Alvis N, Díaz D, Castillo L, Alvis N, Bermúdez M, Berrío O, et al. Costos de la prueba de tamización para la enfermedad de Chagas en donantes de dos bancos de sangre de Colombia, 2015. Biomedica [Internet]. 2018 [Cited 11/12/2020];38(1):61-8. Available from: https://cutt.ly/CfupFkP
38. Gonzalez L, Scollo K, Saez A, Ferlin C, Albajar P, Ciapponi A, et al. Inmunoserología y métodos moleculares para el diagnóstic de Chagas: revisión sistemática rápida. Acta Bioquím Clín Latinoam [Internet]. 2017 [Cited 12/01/2021];51(1):63-74. Available from: https://cutt.ly/gzcpU2k
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