Immunochromatographic tests for human and canine leishmaniosis diagnosis: a critical review and future prospects
Yessenia Cristhel Manrique Guzman; Manuel Hospinal-Santiani; Carlos Ricardo Soccol; Vanete Thomaz-Soccol
Abstract
Leishmaniosis has two main clinical forms: cutaneous and visceral leishmaniosis, which can leave serious sequelae and even cause death if not properly diagnosed and treated. Diagnostic methods include parasitological, immunological, or DNA amplification. Rapid immunochromatographic tests (ICTs) are considered the best option for an initial diagnosis of leishmaniosis at the point of care and disease control. This is because they are easy to use, interpret, and are low-cost. This paper reviews the diagnostic performance of commercial ICTs evaluated and published by various researchers. A total of 78 articles were found, 50 of which correspond to human leishmaniosis, and the other 28 address canine leishmaniosis. Many of these kits do not present high sensitivity and specificity, and their use as screening methods in endemic areas is problematic. Recombinant proteins rK39 and rK28 were used as antigens in the commercial test for diagnosing both human visceral leishmaniosis (VL) and canine visceral leishmaniosis (CVL), and they showed similar performance. However, a lot of discrepancies among authors related to sensitivity and specificity results make it difficult to choose or recommend any of these commercial ICTs for an effective diagnosis of leishmaniosis. Only the ICT with recombinant protein rKE16 showed good performance for VL diagnosis in Asia. In contrast, the CL Detect™ Rapid Test, which uses peroxidoxin as an antigen, is the only approved test to diagnose cutaneous leishmaniosis (CL), but it showed low sensitivity on the three continents (Africa, Asia, and South America) where CL is endemic. The review conducted in this study indicates the need to consider the Leishmania species that are infecting the endemic area in the development of the antigen used in ICTs, together with the development of platforms and/or new techniques that increase the efficiency of ICTs.
Keywords
References
Abass, E., Bollig, N., Reinhard, K., Camara, B., Mansour, D., Visekruna, A., Lohoff, M., & Steinhoff, U. (2013). rKLO8, a novel Leishmania donovani - derived recombinant immunodominant protein for sensitive detection of visceral leishmaniasis in Sudan. PLoS Neglected Tropical Diseases, 7(7), e2322. http://dx.doi. org/10.1371/journal.pntd.0002322. PMid:23875052.
Anversa, L., Tiburcio, M. G. S., Richini-Pereira, V. B., & Ramirez, L. E. (2018). Human leishmaniasis in Brazil: A general review. Revista da Associação Médica Brasileira, 64(3), 281-289. http://dx.doi. org/10.1590/1806-9282.64.03.281. PMid:29641786.
Assis, T. S. M., Braga, A. S., Pedras, M. J., Oliveira, E., Barral, A., de Siqueira, I., Costa, C., Costa, D., Holanda, T. A., Soares, V. Y. R., Biá, M., Caldas, A., Romero, G., & Rabello, A. (2011). Multi-centric prospective evaluation of rk39 rapid test and direct agglutination test for the diagnosis of visceral leishmaniasis in Brazil. Transactions of the Royal Society of Tropical Medicine and Hygiene, 105(2), 81-85. http://dx.doi.org/10.1016/j.trstmh.2010.09.004. PMid:20970152.
Assis, T. S., Braga, A., Pedras, M., Barral, A., de Siqueira, I., Costa, C., Costa, D., Holanda, T., Soares, V., Biá, M., Caldas, A., Romero, G., & Rabello, A. (2008). Validation of the rapid immunochromatographic test IT-LEISH® for the diagnosis of human visceral leishmaniasis. Epidemiologia e Serviços de Saúde: Revista do Sistema Unico de Saúde do Brasil, 17, 2.
Athanasiou, L. V., Petanides, T. A., Chatzis, M. K., Kasabalis, D., Apostolidis, K. N., & Saridomichelakis, M. N. (2014). Comparison of two commercial rapid in-clinic serological tests for detection of antibodies against Leishmania spp. in dogs. Journal of Veterinary Diagnostic Investigation, 26(2), 286-290. http://dx.doi. org/10.1177/1040638714523614. PMid:24569224.
Bangert, M., Flores-Chávez, M. D., Llanes-Acevedo, I. P., Arcones, C., Chicharro, C., García, E., Ortega, S., Nieto, J., & Cruz, I. (2018). Validation of rK39 immunochromatographic test and direct agglutination test for the diagnosis of Mediterranean visceral leishmaniasis in Spain. PLoS Neglected Tropical Diseases, 12(3), e0006277. http://dx.doi.org/10.1371/journal.pntd.0006277. PMid:29494596.
Banu, S. S., Ahmed, B. N., Shamsuzzaman, A. K. M., & Lee, R. (2016). Evaluation of recombinant K39 antigen and various promastigote antigens in sero-diagnosis of visceral leishmaniasis in Bangladesh. Parasite Epidemiology and Control, 1(3), 219-228. http://dx.doi. org/10.1016/j.parepi.2016.07.003. PMid:29988192.
Basurco, A., Natale, A., Capello, K., Fernández, A., Verde, M. T., González, A., Yzuel, A., Giner, J., & Villanueva-Saz, S. (2020). Evaluation of the performance of three serological tests for diagnosis of Leishmania infantum infection in dogs using latent class analysis. Revista Brasileira de Parasitologia Veterinária, 29(4), e018020. http://dx.doi.org/10.1590/s1984-29612020105. PMid:33295380.
Bengtson, M., Bharadwaj, M., Franch, O., van der Torre, J., Meerdink, V., Schallig, H., & Dekker, C. (2022). CRISPR-dCas9 based DNA detection scheme for diagnostics in resource-limited settings. Nanoscale, 14(5), 1885-1895. http://dx.doi.org/10.1039/D1NR06557B. PMid:35044397.
Bennis, I., Verdonck, K., el Khalfaoui, N., Riyad, M., Fellah, H., Dujardin, J. C., Sahibi, H., Bouhout, S., van der Auwera, G., & Boelaert, M. (2018). Accuracy of a rapid diagnostic test based on antigen detection for the diagnosis of cutaneous leishmaniasis in patients with suggestive skin lesions in Morocco. The American Journal of Tropical Medicine and Hygiene, 99(3), 716-722. http://dx.doi.org/10.4269/ajtmh.18-0066. PMid:29988004.
Bern, C., Jha, S. N., Joshi, A. B., Thakur, G. D., & Bista, M. B. (2000). Use of the recombinant K39 dipstick test and the direct agglutination test in a setting endemic for visceral leishmaniasis in Nepal. The American Journal of Tropical Medicine and Hygiene, 63(3–4), 153-157. http://dx.doi.org/10.4269/ajtmh.2000.63.153. PMid:11388508.
Bezuneh, A., Mukhtar, M., Abdoun, A., Teferi, T., Takele, Y., Diro, E., Jemaneh, A., Shiferaw, W., Wondimu, H., Bhatia, A., Howard, R. F., Ghalib, H., Ireton, G. C., Hailu, A., & Reed, S. G. (2014). Comparison of point-of-care tests for the rapid diagnosis of visceral leishmaniasis in east African patients. The American Journal of Tropical Medicine and Hygiene, 91(6), 1109-1115. http://dx.doi. org/10.4269/ajtmh.13-0759. PMid:25311696.
Boelaert, M., El-Safi, S., Hailu, A., Mukhtar, M., Rijal, S., Sundar, S., Wasunna, M., Aseffa, A., Mbui, J., Menten, J., Desjeux, P., & Peeling, R. W. (2008). Diagnostic tests for kala-azar: a multicentre study of the freeze-dried DAT, rK39 strip test and KAtex in East Africa and the Indian subcontinent. Transactions of the Royal Society of Tropical Medicine and Hygiene, 102(1), 32-40. http://dx.doi.org/10.1016/j.trstmh.2007.09.003. PMid:17942129.
Brandonisio, O., Fumarola, L., Maggi, P., Cavaliere, R., Spinelli, R., & Pastore, G. (2002). Evaluation of a rapid immunochromatographic test for serodiagnosis of visceral leishmaniasis. European Journal of Clinical Microbiology & Infectious Diseases, 21(6), 461-464. http://dx.doi.org/10.1007/s10096-002-0739-8. PMid:12111603.
Brito, R., Aguiar-Soares, R., Cardoso, J., Coura-Vital, W., Roatt, B., & Reis, A. (2020). Recent advances and new strategies in leishmaniasis diagnosis. Applied Microbiology and Biotechnology, 104(19), 8105-8116. http://dx.doi.org/10.1007/s00253-020- 10846-y. PMid:32845368.
Cañavate, C., Herrero, M., Nieto, J., Cruz, I., Chicharro, C., Aparicio, P., Mulugeta, A., Argaw, D., Blackstock, A. J., Alvar, J., & Bern, C. (2011). Evaluation of two rK39 dipstick tests, direct agglutination test, and indirect fluorescent antibody test for diagnosis of visceral leishmaniasis in a new epidemic site in highland Ethiopia. The American Journal of Tropical Medicine and Hygiene, 84(1), 102-106. http://dx.doi.org/10.4269/ ajtmh.2011.10-0229. PMid:21212210.
Castillo-Castañeda, A., Patiño, L. H., Muñoz, M., Ayala, M. S., Segura, M., Bautista, J., Shaban, M., Paniz-Mondolfi, A., & Ramírez, J. D. (2022). Amplicon-based next-generation sequencing reveals the co-existence of multiple Leishmania species in patients with visceral leishmaniasis. International Journal of Infectious Diseases, 115, 35-38. http://dx.doi.org/10.1016/j.ijid.2021.11.029. PMid:34863923.
Chakravarty, J., Kumar, S., Kumar, R., Gautam, S., Rai, M., & Sundar, S. (2011). Evaluation of rk39 immunochromatographic test with urine for diagnosis of visceral leishmaniasis. Transactions of the Royal Society of Tropical Medicine and Hygiene, 105(9), 537-539. http://dx.doi.org/10.1016/j.trstmh.2011.05.008. PMid:21708392.
Chappuis, F., Mueller, Y., Nguimfack, A., Rwakimari, J. B., Couffignal, S., Boelaert, M., Cavailler, P., Loutan, L., & Piola, P. (2005). Diagnostic accuracy of two rK39 antigen-based dipsticks and the formol gel test for rapid diagnosis of visceral leishmaniasis in northeastern Uganda. Journal of Clinical Microbiology, 43(12), 5973-5977. http://dx.doi.org/10.1128/JCM.43.12.5973- 5977.2005. PMid:16333084.
Chappuis, F., Rijal, S., Jha, U. K., Desjeux, P., Karki, B. M. S., Koirala, S., Loutan, L., & Boelaert, M. (2006). Field validity, reproducibility, and feasibility of diagnostic tests for visceral leishmaniasis in rural Nepal. Tropical Medicine & International Health, 11(1), 31-40. http:// dx.doi.org/10.1111/j.1365-3156.2005.01533.x. PMid:16398753.
Chappuis, F., Rijal, S., Singh, R., Acharya, P., Karki, B. M. S., Das, M. L., Bovier, P. A., Desjeux, P., le Ray, D., Koirala, S., & Loutan, L. (2003). Prospective evaluation and comparison of the direct agglutination test and an rK39-antigen-based dipstick test for the diagnosis of suspected kala-azar in Nepal. Tropical Medicine & International Health, 8(3), 277-285. http://dx.doi.org/10.1046/ j.1365-3156.2003.01026.x. PMid:12631320.
Cota, G. F., Sousa, M. R., Freitas Nogueira, B. M., Gomes, L. I., Oliveira, E., Assis, T. S. M., Mendonca, A. L. P., Pinto, B. F., Saliba, J. W., & Rabello, A. (2013). Comparison of parasitological, serological, and molecular tests for visceral leishmaniasis in HIV-infected patients: A cross-sectional delayed-type study. The American Journal of Tropical Medicine and Hygiene, 89(3), 570-577. http://dx.doi. org/10.4269/ajtmh.13-0239. PMid:23836568.
Farahmand, M., Khalaj, V., Mohebali, M., Khalili, G., Naderi, S., Ghaffarinejad, P., & Nahrevanian, H. (2015). Comparison of recombinant A2-ELISA with rKE16 dipstick and direct agglutination tests for diagnosis of visceral leishmaniasis in dogs in Northwestern Iran. Revista da Sociedade Brasileira de Medicina Tropical, 48(2), 188-193. http://dx.doi.org/10.1590/0037-8682-0285-2014. PMid:25992934.
Ferroglio, E., Zanet, S., Mignone, W., Poggi, M., Trisciuoglio, A., & Bianciardi, P. (2013). Evaluation of a rapid device for serological diagnosis of Leishmania infantum infection in dogs as an alternative to immunofluorescence assay and Western blotting. Clinical and Vaccine Immunology; CVI, 20(5), 657-659. http://dx.doi.org/10.1128/CVI.00719-12. PMid:23446218.
Figueiredo, F. B., de Vasconcelos, T. C. B., Madeira, M. F., Menezes, R. C., Maia-Elkhoury, A. N. S., Marcelino, A. P., & Werneck, G. L. (2018). Validation of the Dual-path Platform chromatographic immunoassay (DPP® CVL rapid test) for the serodiagnosis of canine visceral leishmaniasis. Memorias do Instituto Oswaldo Cruz, 113(11), e180260. http://dx.doi.org/10.1590/0074-02760180260. PMid:30379198.
Figueiredo, M. M., Dos Santos, A. R. R., Godoi, L. C., de Castro, N. S., de Andrade, B. C., Sergio, S. A. R., Jerônimo, S. M. B., de Oliveira, E. J., Valencia-Portillo, R. T., Bezerra, L. M., Goto, H., Sanchez, M. C. A., Junqueira, C., Teixeira, S. M. R., da Fonseca, F. G., Gazzinelli, R. T., & Fernandes, A. P. (2021). Improved performance of elisa and immunochromatographic tests using a new chimeric A2-based protein for human visceral leishmaniasis diagnosis. Journal of Immunology Research, 2021, 5568077. http://dx.doi.org/10.1155/2021/5568077. PMid:34007852.
Fraga, D. B. M., da Silva, E. D., Pacheco, L. V., Borja, L. S., de Oliveira, I. Q., Coura-Vital, W., Monteiro, G. R., Oliveira, G. G. D. S., Jerônimo, S. M. B., Reis, A. B., & Veras, P. S. T. (2014). A multicentric evaluation of the recombinant Leishmania infantum antigen-based immunochromatographic assay for the serodiagnosis of canine visceral leishmaniasis. Parasites & Vectors, 7(1), 136. http://dx.doi.org/10.1186/1756-3305-7-136. PMid:24684857.
Fraga, D. B. M., Pacheco, L. V., Borja, L. S., Tuy, P. G., Bastos, L. A., Solcà, M., Amorim, L. D. A. F., & Veras, P. S. T. (2016). The Rapid Test Based on Leishmania infantum Chimeric rK28 protein improves the diagnosis of canine visceral leishmaniasis by reducing the detection of false-positive dogs. PLoS Neglected Tropical Diseases, 10(1), e0004333. http://dx.doi.org/10.1371/journal. pntd.0004333. PMid:26731098.
Freire, M. L., Assis, T. S. M., Avelar, D. M., Rabello, A., & Cota, G. (2018). Evaluation of a new brand of immunochromatographic test for visceral leishmaniasis in Brazil made available from 2018. Revista do Instituto de Medicina Tropical de São Paulo, 60(0), e49. http://dx.doi.org/10.1590/s1678-9946201860049. PMid:30231169.
Freire, M. L., Machado de Assis, T., Oliveira, E., Moreira de Avelar, D., Siqueira, I. C., Barral, A., Rabello, A., & Cota, G. (2019). Performance of serological tests available in Brazil for the diagnosis of human visceral leishmaniasis. PLoS Neglected Tropical Diseases, 13(7), e0007484. http://dx.doi.org/10.1371/journal. pntd.0007484. PMid:31318856.
Fujisawa, K., Silcott-Niles, C., Simonson, P., Lamattina, D., Humeres, C. A., Bhattacharyya, T., Mertens, P., Thunissen, C., O’rourke, V., Pańczuk, M., Whitworth, J. A., Salomón, O. D., & Miles, M. A. (2021). Emergent canine visceral leishmaniasis in Argentina: comparative diagnostics and relevance to proliferation of human disease. PLoS Neglected Tropical Diseases, 15(7), e0009552. http://dx.doi.org/10.1371/journal.pntd.0009552. PMid:34280201.
Gedda, M. R., Madhukar, P., Shukla, A., Mudavath, S. L., Srivastava, O. N., Singh, O. P., & Sundar, S. (2021). Nanodiagnostics in leishmaniasis: a new frontiers for early elimination. Wiley Interdisciplinary Reviews. Nanomedicine and Nanobiotechnology, 13(2), e1675. http://dx.doi.org/10.1002/wnan.1675. PMid:33142369.
Ghosh, P., Hasnain, M. G., Ghosh, D., Hossain, F., Baker, J., Boelaert, M., Rijal, S., & Mondal, D. (2015). A comparative evaluation of the performance of commercially available rapid immunochromatographic tests for the diagnosis of visceral leishmaniasis in Bangladesh. Parasites & Vectors, 8(1), 331. http://dx.doi.org/10.1186/s13071-015-0935-x. PMid:26077956.
Grimaldi Junior, G., Teva, A., Ferreira, A. L., dos Santos, C. B., Pinto, I. S., de-Azevedo, C. T., & Falqueto, A. (2012). Evaluation of a novel chromatographic immunoassay based on Dual-Path Platform technology (DPP ® CVL rapid test) for the serodiagnosis of canine visceral leishmaniasis. Transactions of the Royal Society of Tropical Medicine and Hygiene, 106(1), 54-59. http://dx.doi. org/10.1016/j.trstmh.2011.10.001. PMid:22137538.
Herrera, G., Castillo, A., Ayala, M. S., Flórez, C., Cantillo-Barraza, O., & Ramirez, J. D. (2019). Evaluation of four rapid diagnostic tests for canine and human visceral leishmaniasis in Colombia. BMC Infectious Diseases, 19(1), 747. http://dx.doi.org/10.1186/ s12879-019-4353-0. PMid:31455227.
Humbert, M. V., Costa, L. E., Katis, I., Fonseca Ramos, F., Sanchéz Machado, A., Sones, C., Ferraz Coelho, E. A., & Christodoulides, M. (2019). A rapid diagnostic test for human Visceral Leishmaniasis using novel Leishmania antigens in a laser direct-write lateral flow device. Emerging Microbes & Infections, 8(1), 1178-1185. http:// dx.doi.org/10.1080/22221751.2019.1635430. PMid:31381478.
Kammona, O., & Tsanaktsidou, E. (2021). Nanotechnologyaided diagnosis, treatment, and prevention of leishmaniasis. International Journal of Pharmaceutics, 605, 120761. http:// dx.doi.org/10.1016/j.ijpharm.2021.120761. PMid:34081999.
Kassa, M., Abdellati, S., Cnops, L., Bremer Hinckel, B. C., Yeshanew, A., Hailemichael, W., Vogt, F., Adriaensen, W., Mertens, P., Diro, E., van Griensven, J., & van den Bossche, D. (2020). Diagnostic accuracy of direct agglutination test, rK39 ELISA and six rapid diagnostic tests among visceral leishmaniasis patients with and without HIV coinfection in Ethiopia. PLoS Neglected Tropical Diseases, 14(12), e0008963. http://dx.doi.org/10.1371/journal. pntd.0008963. PMid:33382690.
Khan, M. G. M., Alam, M. S., Bhuiyan, A. T., Jamil, M. A., Saha, B., Islam, M., Haque, R., Hossain, M., & Jamil, K. M. (2011). Short communication: evaluation of a new rapid diagnostic test for quality assurance by kala azar elimination programme in Bangladesh. Journal of Parasitology Research, 2011, 862475. http://dx.doi.org/10.1155/2011/862475. PMid:22132308.
Kiros, Y. K., & Regassa, B. F. (2017). The role of rk39 serologic test in the diagnosis of visceral leishmaniasis in a Tertiary Hospital, Northern Ethiopia. BMC Research Notes, 10(1), 169. http://dx.doi. org/10.1186/s13104-017-2490-3. PMid:28446246.
Laurenti, M. D., Santana Leandro Junior, M. V., Tomokane, T. Y., Lucca, H. R. L., Aschar, M., Souza, C. S. F., Silva, R. M., Marcondes, M., & da Matta, V. L. R. (2014). Comparative evaluation of the DPP® CVL rapid test for canine serodiagnosis in area of visceral leishmaniasis. Veterinary Parasitology, 205(3–4), 444-450. http:// dx.doi.org/10.1016/j.vetpar.2014.09.002. PMid:25257505.
Lemos, E. M., Laurenti, M. D., Moreira, M. A. B., Reis, A. B., Giunchetti, R. C., Raychaudhuri, S., & Dietze, R. (2008). Canine visceral leishmaniasis: Performance of a rapid diagnostic test (Kalazar DetectTM) in dogs with and without signs of the disease. Acta Tropica, 107(2), 205-207. http://dx.doi.org/10.1016/j. actatropica.2008.04.023. PMid:18565485.
Lévêque, M. F., Battery, E., Delaunay, P., Lmimouni, B. E., Aoun, K., L’Ollivier, C., Bastien, P., Mary, C., Pomares, C., Fillaux, J., & Lachaud, L. (2020). Evaluation of six commercial kits for the serological diagnosis of mediterranean visceral leishmaniasis. PLoS Neglected Tropical Diseases, 14(3), e0008139. http://dx.doi. org/10.1371/journal.pntd.0008139. PMid:32210438.
Machado de Assis, T. S., Rabello, A., & Werneck, G. L. (2012). Latent class analysis of diagnostic tests for visceral leishmaniasis in Brazil. Tropical Medicine & International Health, 17(10), 1202- 1207. http://dx.doi.org/10.1111/j.1365-3156.2012.03064.x. PMid:22897740.
Maia, C., Fraga, D. B. M., Cristóvão, J., Borja, L. S., da Silva Solcà, M., Campino, L., Veras, P. S. T., & Gonçalves, L. (2022). Leishmania exposure in dogs from two endemic countries from New and Old Worlds (Brazil and Portugal): Evaluation of three serological tests using Bayesian Latent Class Models. Parasites & Vectors, 15(1), 202. http://dx.doi.org/10.1186/s13071-022-05328-1. PMid:35698163.
Mbui, J., Wasunna, M., Balasegaram, M., Laussermayer, A., Juma, R., Njenga, S. N., Kirigi, G., Riongoita, M., de la Tour, R., van Peteghem, J., Omollo, R., & Chappuis, F. (2013). Validation of two rapid diagnostic tests for visceral leishmaniasis in Kenya. PLoS Neglected Tropical Diseases, 7(9), e2441. http://dx.doi. org/10.1371/journal.pntd.0002441. PMid:24086782.
Mettler, M., Grimm, F., Capelli, G., Camp, H., & Deplazes, P. (2005). Evaluation of enzyme-linked immunosorbent assays, an immunofluorescent-antibody test, and two rapid tests (immunochromatographic-dipstick and gel tests) for serological diagnosis of symptomatic and asymptomatic Leishmania infections in dogs. Journal of Clinical Microbiology, 43(11), 5515-5519. http:// dx.doi.org/10.1128/JCM.43.11.5515-5519.2005. PMid:16272479.
Mniouil, M., Fellah, H., Amarir, F., Sadak, A., Et-touys, A., Bakri, Y., Moustachi, A., Tassou, F. Z., Hida, M., Lyagoubi, M., Adlaoui, E. B., Rhajaoui, M., & Sebti, F. (2018). Comparative evaluation of immunochromatographic dipstick test (ICT) rk39, soluble antigen ELISA and IFAT for the sero-diagnosis of visceral leishmaniasis in Morocco. Acta Tropica, 182, 185-189. http://dx.doi.org/10.1016/j. actatropica.2018.03.007. PMid:29545149.
Mohebali, M., Taran, M., & Zarei, Z. (2004). Rapid detection of Leishmania infantum infection in dogs: Comparative study using an immunochromatographic dipstick rk39 test and direct agglutination. Veterinary Parasitology, 121(3-4), 239-245. http:// dx.doi.org/10.1016/j.vetpar.2004.02.014. PMid:15135863.
Monno, R., Giannelli, G., Rizzo, C., de Vito, D., & Fumarola, L. (2009). Recombinant K39 immunochromatographic test for diagnosis of human leishmaniasis. Future Microbiology, 4(2), 159-170. http:// dx.doi.org/10.2217/17460913.4.2.159. PMid:19257843.
Moura, A. S., Lopes, H. M. R., Mourão, M. V. A., & Morais, M. H. F. (2013). Performance of a rapid diagnostic test for the detection of visceral leishmaniasis in a large urban setting. Revista da Sociedade Brasileira de Medicina Tropical, 46(5), 589-593. http://dx.doi. org/10.1590/0037-8682-0145-2013. PMid:24270249.
Mukhtar, M., Abdoun, A., Ahmed, A. E., Ghalib, H., Reed, S. G., Boelaert, M., Menten, J., Khair, M. M., & Howard, R. F. (2015). Diagnostic accuracy of rK28-based immunochromatographic rapid diagnostic tests for visceral leishmaniasis: A prospective clinical cohort study in Sudan. Transactions of the Royal Society of Tropical Medicine and Hygiene, 109(9), 594-600. http://dx.doi. org/10.1093/trstmh/trv060. PMid:26246251.
Nzelu, C. O., Kato, H., & Peters, N. C. (2019). Loop-mediated isothermal amplification (LAMP): An advanced molecular pointof- care technique for the detection of Leishmania infection. PLoS Neglected Tropical Diseases, 13(11), e0007698. http://dx.doi. org/10.1371/journal.pntd.0007698. PMid:31697673.
Organização Pan-Americana da Saúde. (2020). Leishmanioses: informe epidemiológico nas Américas, dezembro de 2020. OPAS/CDE/VT/20- 0041. https://iris.paho.org/handle/10665.2/53091
Ortalli, M., Lorrai, D., Gaibani, P., Rossini, G., Vocale, C., Re, M. C., & Varani, S. (2020). Serodiagnosis of visceral leishmaniasis in northeastern Italy: Evaluation of seven serological tests. Microorganisms, 8(12), 1-6. http://dx.doi.org/10.3390/ microorganisms8121847. PMid:33255210.
Otranto, D., Paradies, P., Sasanelli, M., Spinelli, R., & Brandonisio, O. (2004). Rapid immunochromatographic test for serodiagnosis of canine leishmaniasis. Journal of Clinical Microbiology, 42(6), 2769-2770. http://dx.doi.org/10.1128/JCM.42.6.2769-2770.2004. PMid:15184465.
Peruhype-Magalhães, V., Machado de Assis, T., & Rabello, A. (2012). Use of the Kala-Azar Detect® and IT-LEISH® rapid tests for the diagnosis of visceral leishmaniasis. Memorias do Instituto Oswaldo Cruz, 107(7), 951-952. http://dx.doi.org/10.1590/ S0074-02762012000700019. PMid:23147155.
Proverbio, D., Spada, E., Baggiani, L., Bagnagatti De Giorgi, G., & Perego, R. (2013). Comparison of a clinic-based ELISA test kit with the immunofluorescence antibody test for assaying Leishmania infantum antibodies in dogs. BioMed Research International, 2013, 249010. http://dx.doi.org/10.1155/2013/249010. PMid:24187662.
Proverbio, D., Spada, E., Perego, R., Baggiani, L., Bagnagatti De Giorgi, G., Migliazzo, A., & Vitale, F. (2016). Comparison of a rapid immunochromatographic assay with an immunofluorescent antibody test for detection of Leishmania infantum antibodies in dogs. Veterinary Clinical Pathology, 45(4), 623-626. http://dx.doi.org/10.1111/vcp.12408. PMid:27977059.
Quinnell, R. J., Carson, C., Reithinger, R., Garcez, L. M., & Courtenay, O. (2013). Evaluation of rK39 rapid diagnostic tests for canine visceral leishmaniasis: longitudinal study and meta-analysis. PLoS Neglected Tropical Diseases, 7(1), e1992. http://dx.doi. org/10.1371/journal.pntd.0001992. PMid:23326615.
Reithinger, R., Quinnell, R. J., Alexander, B., & Davies, C. R. (2002). Rapid detection of Leishmania infantum infection in dogs: comparative study using an immunochromatographic dipstick test, enzyme-linked immunosorbent assay, and PCR. Journal of Clinical Microbiology, 40(7), 2352-2356. http://dx.doi.org/10.1128/ JCM.40.7.2352-2356.2002. PMid:12089247.
Rezaei, Z., Pourabbas, B., Asaei, S., Kühne, V., Sepehrpour, S., Pouladfar, G., Keihani, N., & Büscher, P. (2021). Pediatric visceral leishmaniasis: A retrospective study to propose the diagnostic tests algorithm in southern Iran. Parasitology Research, 120(4), 1447-1453. http://dx.doi.org/10.1007/s00436-021-07067-1. PMid:33576903.
Rezaei, Z., Pourabbas, B., Kühne, V., Pourabbas, P., & Büscher, P. (2022). Diagnostic performance of three rk39 rapid diagnostic tests and two direct agglutination tests for the diagnosis of visceral leishmaniasis in southern Iran. Journal of Tropical Medicine, 2022, 3569704. http://dx.doi.org/10.1155/2022/3569704. PMid:35449755.
Rezaei, Z., van Reet, N., Pouladfar, G., Kühne, V., Ramezani, A., Sarkari, B., Pourabbas, B., & Büscher, P. (2019). Expression of a rK39 homologue from an Iranian Leishmania infantum isolate in Leishmania tarentolae for serodiagnosis of visceral leishmaniasis. Parasites & Vectors, 12(1), 593. http://dx.doi.org/10.1186/ s13071-019-3839-3. PMid:31852505.
Ribeiro, R. A. N., Teixeira-Neto, R. G., Belo, V. S., Ferreira, E. C., Schallig, H. D. F. H., & Silva, E. S. (2015). Ability of immunodiagnostic tests to differentiate between dogs naturally infected with Leishmania infantum and Leishmune(®)-vaccinated dogs. Veterinary Research Communications, 39(2), 87-95. http:// dx.doi.org/10.1007/s11259-015-9625-6. PMid:25874857.
Ribeiro, V. M., Miranda, J. B., Marcelino, A. P., de Andrade, H. M., Reis, I. A., Cardoso, M. S., Gontijo, C. M. F., & Paz, G. F. (2019). Performance of different serological tests in the diagnosis of natural infection by Leishmania infantum in dogs. Veterinary Parasitology, 274, 108920. http://dx.doi.org/10.1016/j. vetpar.2019.08.014. PMid:31493694.
Ritmeijer, K., Melaku, Y., Mueller, M., Kipngetich, S., O’keeffe, C., & Davidson, R. N. (2006). Evaluation of a new recombinant K39 rapid diagnostic test for Sudanese visceral leishmaniasis. The American Journal of Tropical Medicine and Hygiene, 74(1), 76-80. http://dx.doi.org/10.4269/ajtmh.2006.74.76. PMid:16407349.
Rodríguez-Cortés, A., Ojeda, A., Todolí, F., & Alberola, J. (2013). Performance of commercially available serological diagnostic tests to detect Leishmania infantum infection on experimentally infected dogs. Veterinary Parasitology, 191(3–4), 363-366. http://dx.doi.org/10.1016/j.vetpar.2012.09.009. PMid:23021261.
Saghrouni, F., Gaïed-Meksi, S., Fathallah, A., Amri, F., Ach, H., Guizani, I., & Ben Saïd, M. (2009). Immunochromatographic rK39 strip test in the serodiagnosis of visceral leishmaniasis in Tunisia. Transactions of the Royal Society of Tropical Medicine and Hygiene, 103(12), 1273-1278. http://dx.doi.org/10.1016/j. trstmh.2008.10.034. PMid:19070876.
Salomón, O. D., Pérez, A. A., Riarte, A. R., Casas, N., Fragueiro-Frías, V., Negri, V., Santini, M. S., & Liotta, D. J. (2020). Performance of DPP and rk39 for CVL performance of rapid tests for canine visceral leishmaniasis diagnosis in Argentina. Medicina (B Aires), 80(2), 103-110. PMid:32282314.
Sanchez, M. C. A., Celeste, B. J., Lindoso, J. A. L., Fujimori, M., Almeida, R. P., Fortaleza, C. M. C. B., Druzian, A. F., Lemos, A. P. F., Melo, V. C. A., Paniago, A. M. M., Queiroz, I. T., & Goto, H. (2020). Performance of rK39-based immunochromatographic rapid diagnostic test for serodiagnosis of visceral leishmaniasis using whole blood, serum and oral fluid. PLoS One, 15(4), e0230610. http://dx.doi.org/10.1371/journal.pone.0230610. PMid:32240188.
Schallig, H. D. F. H., Hu, R. V. P., Kent, A. D., van Loenen, M., Menting, S., Picado, A., Oosterling, Z., & Cruz, I. (2019). Evaluation of point of care tests for the diagnosis of cutaneous leishmaniasis in Suriname. BMC Infectious Diseases, 19(1), 25. http://dx.doi. org/10.1186/s12879-018-3634-3. PMid:30616544.
Schubach, A. O., Marzochi, K. B. F., Moreira, J. S., Schubach, T. M. P., Araújo, M. L., Vale, A. C. F., Passos, S. R., & Marzochi, M. C. (2005). Retrospective study of 151 patients with cutaneous leishmaniasis treated with meglumine antimoniate. Revista da Sociedade Brasileira de Medicina Tropical, 38(3), 213-217. http://dx.doi.org/10.1590/S0037-86822005000300001. PMid:15895170.
Schubach, E. Y. P., Figueiredo, F. B., & Romero, G. A. S. (2014). Accuracy and reproducibility of a rapid chromatographic immunoassay for the diagnosis of canine visceral leishmaniasis in Brazil. Transactions of the Royal Society of Tropical Medicine and Hygiene, 108(9), 568-574. http://dx.doi.org/10.1093/trstmh/ tru109. PMid:25015665.
Silva, D. A., Madeira, M. de F., Abrantes, T. R., Filho, C. J., & Figueiredo, F. B. (2013). Assessment of serological tests for the diagnosis of canine visceral leishmaniasis. Veterinary Journal (London, England), 195(2), 252-253. http://dx.doi.org/10.1016/j. tvjl.2012.06.010. PMid:22789627.
Silva, G., Somaratne, V., Senaratne, S., Vipuladasa, M., Wickremasinghe, R., Wickremasinghe, R., & Ranasinghe, S. (2017). Efficacy of a new rapid diagnostic test kit to diagnose Sri Lankan cutaneous leishmaniasis caused by Leishmania donovani. PLoS One, 12(11), e0187024. http://dx.doi.org/10.1371/journal. pone.0187024. PMid:29135995.
Silva, M. R. B., Brandão, N. A. A., Colovati, M., Sousa, M. M. P., Lima, L. C., Dorta, M. L., Ribeiro-Dias, F., Costa, D. L., Costa, C. H. N., & de Oliveira, M. A. P. (2018). Performance of two immunochromatographic tests for diagnosis of visceral leishmaniasis in patients coinfected with HIV. Parasitology Research, 117(2), 419-427. http://dx.doi.org/10.1007/s00436- 017-5716-3. PMid:29270768.
Singh, D. P., Goyal, R. K., Singh, R. K., Sundar, S., & Mohapatra, T. M. (2010). In search of an ideal test for diagnosis and prognosis of kala-azar. Journal of Health, Population and Nutrition, 28(3), 281-285. PMid:20635639.
Solano-Gallego, L., Villanueva-Saz, S., Carbonell, M., Trotta, M., Furlanello, T., & Natale, A. (2014). Serological diagnosis of canine leishmaniosis: Comparison of three commercial ELISA tests (Leiscan®, ID Screen® and Leishmania 96®), a rapid test (Speed Leish K®) and an in-house IFAT. Parasites & Vectors, 7(1), 111. http://dx.doi.org/10.1186/1756-3305-7-111. PMid:24655335.
Souza Filho, J. A., Barbosa, J. R., Figueiredo, F. B., Mendes, A. A. V., Silva, S. R., Coelho, G. L. L. M., & Marcelino, A. P. (2016). Performance of AlereTM immunochromathographic test for the diagnosis of canine visceral leishmaniasis. Veterinary Parasitology, 225, 114-116. http://dx.doi.org/10.1016/j.vetpar.2016.06.011. PMid:27369585.
Souza, C., Silva, V., & Labarthe, N. (2019). Evaluation of DPP® and SNAP® rapid tests for diagnosis of Leishmania infantum canine infections. Revista da Sociedade Brasileira de Medicina Tropical, 52, e20190154. http://dx.doi.org/10.1590/0037-8682-0154-2019. PMid:31340376.
Sundar, S., Singh, R. K., Maurya, R., Kumar, B., Chhabra, A., Singh, V., & Rai, M. (2006). Serological diagnosis of Indian visceral leishmaniasis: Direct agglutination test versus rK39 strip test. Transactions of the Royal Society of Tropical Medicine and Hygiene, 100(6), 533-537. http://dx.doi.org/10.1016/j.trstmh.2005.08.018. PMid:16325874.
Vaish, M., Sharma, S., Chakravarty, J., & Sundar, S. (2012). Evaluation of two novel rapid rKE16 antigen-based tests for diagnosis of visceral leishmaniasis in India. Journal of Clinical Microbiology, 50(9), 3091-3092. http://dx.doi.org/10.1128/JCM.00475-12. PMid:22760038.
Van Henten, S., Fikre, H., Melkamu, R., Dessie, D., Mekonnen, T., Kassa, M., Bogale, T., Mohammed, R., Cnops, L., Vogt, F., Pareyn, M., & van Griensven, J. (2022). Evaluation of the CL detect rapid test in Ethiopian patients suspected for cutaneous leishmaniasis. PLoS Neglected Tropical Diseases, 16(1), e0010143. http://dx.doi. org/10.1371/journal.pntd.0010143. PMid:35041672.
Varani, S., Ortalli, M., Attard, L., Vanino, E., Gaibani, P., Vocali, C., Rossini, G., Cagarelli, R., Pierro, A., Billi, P., Mastroianni, A., di Cesare, S., Codeluppi, M., Franceschini, E., Melchionda, F., Gramiccia, M., Scalone, A., Gentilomi, G. A., & Landini, M. P. (2017). Serological and molecular tools to diagnose visceral leishmaniasis: 2-years’ experience of a single center in Northern Italy. PLoS One, 12(8), e0183699. http://dx.doi.org/10.1371/ journal.pone.0183699. PMid:28832646.
Veeken, H., Ritmeijer, K., Seaman, J., & Davidson, R. (2003). Comparison of an rK39 dipstick rapid test with direct agglutination test and splenic aspiration for the diagnosis of kala-azar in Sudan. Tropical Medicine & International Health, 8(2), 164-167. http:// dx.doi.org/10.1046/j.1365-3156.2003.00996.x. PMid:12581443.
Villanueva-Saz, S., Basurco, A., Martín, V., Fernández, A., Loste, A., & Verde, M. T. (2019). Comparison of a qualitative immunochromatographic test with two quantitative serological assays for the detection of antibodies to Leishmania infantum in dogs. Acta Veterinaria Scandinavica, 61(1), 38. http://dx.doi. org/10.1186/s13028-019-0473-1. PMid:31391084.
Villanueva-Saz, S., Martínez, M., Ramirez, J. D., Herrera, G., Marteles, D., Servián, M., Verde, M., Giner, J., Lacasta, D., Ruíz, H., Yzuel, A., & Fernández, A. (2022). Evaluation of five different rapid immunochromatographic tests for canine leishmaniosis in Spain. Acta Tropica, 229, 106371. http://dx.doi.org/10.1016/j. actatropica.2022.106371. PMid:35181302.
Vink, M. M., Nahzat, S. M., Rahimi, H., Buhler, C., Ahmadi, B. A., Nader, M., Zazai, F. R., Yousufzai, A. S., van Loenen, M., Schallig, H. D. F. H., Picado, A., & Cruz, I. (2018). Evaluation of point-of-care tests for cutaneous leishmaniasis diagnosis in Kabul, Afghanistan. EBioMedicine, 37, 453-460. http://dx.doi. org/10.1016/j.ebiom.2018.10.063. PMid:30396855.
Welch, R. J., Anderson, B. L., & Litwin, C. M. (2008). Rapid immunochromatographic strip test for detection of anti-K39 immunoglobulin G antibodies for diagnosis of visceral leishmaniasis. Clinical and Vaccine Immunology; CVI, 15(9), 1483-1484. http:// dx.doi.org/10.1128/CVI.00174-08. PMid:18632926.
World Health Organization. (2015). World Health Organization Investing to overcome the global impact of neglected tropical diseases: Third WHO report on neglected tropical diseases. WHO.
Submitted date:
07/06/2023
Accepted date:
10/16/2023
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