1921
Volume 95, Issue 1
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645

Abstract

Abstract

Direct observation of parasites in tissue aspirates has shown low sensitivity for the detection of canine visceral leishmaniasis (VL). Therefore in the last quarter century immunoenzymatic tests have been developed to improve diagnosis. The purpose of this study was to develop a fast recombinant K28 antigen, naked-eye qualitative enzyme-linked immunosorbent assay (VL Ql-ELISA) and a quantitative version (VL Qt-ELISA), and to display it in a kit format, whose cutoff value (0.156) was selected as the most adequate one to differentiate reactive from nonreactive samples. Considering 167 cases and 300 controls, sensitivity was 91% for both assays and specificity was 100% and 98.7% in Ql-ELISA and Qt-ELISA, respectively. Positive predictive values were 100% and 97.4% for Ql-ELISA and Qt-ELISA, respectively, and negative predictive values were 95.2% for both ELISAs. Reagent stability, reliability studies, including periodic repetitions and retest of samples, cutoff selection, and comparison of rK28 ELISAs with rK39 immunochromatographic test, were the international criteria that supported the quality in both kits. The performance of both ELISA kits in this work confirmed their validity and emphasized their usefulness for low-to-medium complexity laboratories.

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References

  1. Arias J, Beltran F, Desjeux P, Walton B, , 1996. Epidemiología y Control de la Leishmaniasis en las Américas, por País o Territorio. Cuaderno Técnico No. 44. Washington, DC: Organización Panamericana de la Salud, 152. [Google Scholar]
  2. Gould IT, Perner MS, Santini MS, Saavedra SB, Bezzi G, Maglianese MI, Antman JG, Gutiérrez JA, Salomón OD, , 2013. Leishmaniasis visceral en la Argentina. Notificación y Situación vectorial (2006–2012). Medicina (Buenos Aires) 73: 104110. [Google Scholar]
  3. Palatnik-de-Sousa CB, Batista-de-Melo LM, Borja-Cabrera GP, Palatnik M, Lavor CC, , 2004. Improving methods for epidemiological control of canine visceral leishmaniasis based on a mathematical model. Impact on the incidence of the canine and human disease. An Acad Bras Cienc 76: 583593.[Crossref] [Google Scholar]
  4. Alves WA, Bevilacqua PD, , 2004. Quality of diagnosis of canine visceral leishmaniasis in epidemiological surveys: an epidemic in Belo Horizonte, Minas Gerais, Brasil, 1993–1997. Cad Saúde Pública 20: 259265.[Crossref] [Google Scholar]
  5. Herwaldt BL, , 1999. Leishmaniasis. Lancet 354: 11911199.[Crossref] [Google Scholar]
  6. Romero GAS, Boelaert M, , 2010. Control of visceral leishmaniasis in Latin America—a systematic review. PLoS Negl Trop Dis 4: 117. [Google Scholar]
  7. Reithinger R, Quinnell RJ, Alexander B, Davies CR, , 2002. Rapid detection of Leishmania infantum infection in dogs: comparative study using an immune chromatographic dipstick test, enzyme-linked immunosorbent assay, and PCR. J Clin Microbiol 40: 23522356.[Crossref] [Google Scholar]
  8. de Castro Ferreira E, de Lana M, Carneiro M, Barbosa Reis A, Vieira Paes D, da Silva ES, Schallig H, Ferreira Gontijo C, , 2007. Comparison of serological assays for the diagnosis of canine visceral leishmaniasis in animals presenting different clinical manifestations. Vet Parasitol 146: 235241.[Crossref] [Google Scholar]
  9. Reithinger R, Lambson BE, Barker DC, Davies CR, , 2000. Use of PCR to detect Leishmania (Viannia) spp. in dog blood and bone marrow. J Clin Microbiol 38: 748751. [Google Scholar]
  10. Reithinger R, Dujardin JC, , 2007. Molecular diagnosis of leishmaniasis: current status and future applications. J Clin Microbiol 45: 2125.[Crossref] [Google Scholar]
  11. Diro E, Techane Y, Tefera T, Assefa Y, Kebede T, Genetu A, Kebede Y, Tesfaye A, Ergicho B, Gebre-Yohannes A, Mengistu G, Engers H, Asseffa A, Desjeux P, Boelaert M, Hailu A, , 2007. Field evaluation of FD-DAT, rK39 dipstick and KATEX (urine latex agglutination) for diagnosis of visceral leishmaniasis in northwest Ethiopia. Trans R Soc Trop Med Hyg 101: 908914.[Crossref] [Google Scholar]
  12. Sundar S, Singh RK, Bimal SK, Gidwani K, Mishra A, Maurya R, Singh SK, Manandhar KD, Boelaert M, Rai M, , 2007. Comparative evaluation of parasitology and serological tests in the diagnosis of visceral leishmaniasis in India: a phase III diagnostic accuracy study. Trop Med Int Health 12: 284289. [Google Scholar]
  13. Boelaert M, El-Safi S, Hailu A, Mukhtar M, Rijal S, Sundar S, Wasunna MA, Aseffa A, Mbui J, Menten J, Desjeux P, Peeling RW, , 2008. Diagnostic tests for kala-azar: a multi-centre study of the freeze-dried DAT, rK39 strip test and KAtex in east Africa and the Indian subcontinent. Trans R Soc Trop Med Hyg 102: 3240.[Crossref] [Google Scholar]
  14. Pattabhi S, Whittle J, Mohamath R, El-Safi S, Moulton GG, Guderian JA, Colombara D, Abdoon AO, Mukhtar MM, Mondal D, Esfandiari J, Kumar S, Chun P, Reed SG, Bhatia A, , 2010. Design, development and evaluation of rK28-based point of care tests for improving rapid diagnosis of visceral leishmaniasis. PLoS Negl Trop Dis 4: 111.[Crossref] [Google Scholar]
  15. Alce TM, Gokool S, McGhie D, Stäger S, Smith DF, , 1999. Expression of hydrophilic surface proteins in infective stages of Leishmania donovani . Mol Biochem Parasitol 102: 191196.[Crossref] [Google Scholar]
  16. Bhatia A, Daifalla NS, Jen S, Badaro R, Reed SG, Skeiky YA, , 1999. Cloning, characterization and serological evaluation of K9 and K26: two related hydrophilic antigens of Leishmania chagasi . Mol Biochem Parasitol 102: 249261.[Crossref] [Google Scholar]
  17. Gürtler RE, , 2009. Sustainability of vector control strategies in the Gran Chaco Region: current challenges and possible approaches. Mem Inst Oswaldo Cruz 104 (Suppl 1): 5259. [Google Scholar]
  18. Jacobson RH, , 1998. Validation of serological assays for diagnosis of infectious diseases. Rev Sci Tech 17: 507526. [Google Scholar]
  19. Lauricella MA, Castañera MB, Gürtler RE, Segura EL, , 1998. Immunodiagnosis of Trypanosoma cruzi (Chagas' disease) infection in naturally infected dogs. Mem Inst Oswaldo Cruz 93: 501507.[Crossref] [Google Scholar]
  20. Gurevitz JM, Ceballos LA, Gaspe MS, Alvarado-Otegui JA, Enriquez GF, Kitron U, Gürtler RE, , 2011. Factors affecting infestation by Triatoma infestans in a rural area of the humid Chaco in Argentina: a multi-model inference approach. PLoS Negl Trop Dis 5: 113.[Crossref] [Google Scholar]
  21. Quinnell RJ, Courtenay O, Garcez L, Dye C, , 1997. The epidemiology of canine leishmaniasis: transmission rates estimated from a cohort study in Amazonian Brazil. Parasitology 115: 143156.[Crossref] [Google Scholar]
  22. Fegan DF, Walker P, Subasinghe R, , 2000. Evaluation of diagnostic tests: the epidemiological approach. , eds. DNA-Based Molecular Diagnostic Techniques: Research Needs for Standardization and Validation of the Detection of Aquatic Animal Pathogens and Diseases. FAO Fisheries Technical Paper 395. Rome, Italy: FAO, 3037. [Google Scholar]
  23. Banoo S, Bell D, Bossuyt P, Herring A, Mabey D, Poole F, Smith PG, Sriram N, Wongsrichanalai CH, Linke R, O'Brien R, Perkins M, Cunningham J, Matsoso P, Nathanson CM, Olliaro P, Peeling RW, Ramsay A, , 2010. Evaluation of diagnostic tests for infectious diseases: general principles. Nat Rev Microbiol 6: S17S29. [Google Scholar]
  24. Taner T, Antony J, , 2000. The assessment of quality in medical diagnostic tests: a comparison of ROC/Jouden and Taguchi methods. Int J Health Care Qual Assur Inc Leadersh Health Serv 13: 300307.[Crossref] [Google Scholar]
  25. Altman DG, Bland JM, , 1994. Diagnostic tests 1: sensitivity and specificity. BMJ 308: 1552.[Crossref] [Google Scholar]
  26. Altman DG, Bland JM, , 1994. Diagnostic tests 2: predictive values. BMJ 309: 102.[Crossref] [Google Scholar]
  27. Rosário EY, Genaro O, França-Silva JC, da Costa RT, Mayrink W, Reis AB, Carneiro M, , 2005. Evaluation of enzyme-linked immunosorbent assay using crude Leishmania and recombinant antigens as a diagnostic marker for canine visceral leishmaniasis. Mem Inst Oswaldo Cruz 100: 197203.[Crossref] [Google Scholar]
  28. Aguirre S, Silber AM, Brito MEF, Ribone ME, Lagier CM, Marcipar IS, , 2006. Design, construction, and evaluation of a specific chimeric antigen to diagnose Chagasic infection. J Clin Microbiol 44: 37683774.[Crossref] [Google Scholar]
  29. Quinnell RJ, Carlson C, Reithinger R, Garcez LM, Courtenay O, , 2013. Evaluation of rK39 rapid diagnostic tests for canine visceral leishmaniasis. Longitudinal study and meta-analysis. PLoS Negl Trop Dis 7: e1992.[Crossref] [Google Scholar]
  30. Grimaldi G, Jr Teva A, Ferreira AL, dos Santos CB, de Souza Pinto I, de Azevedo CT, 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. Trans R Soc Trop Med Hyg 106: 5459.[Crossref] [Google Scholar]
  31. Vega Benedetti AF, Cimino RO, Cajal PS, Juarez M del V, Villalpando CA, Gil JF, Marcipar IS, Krolewiecki AJ, Nasser JR, , 2013. Performance of different Trypanosoma cruzi antigens in the diagnosis of Chagas disease in patients with American cutaneous leishmaniasis from a co-endemic region in Argentina. Trop Med Int Health 18: 11031109.[Crossref] [Google Scholar]
  32. Whiting P, Rutjes AWS, Reitsma JB, Bossuyt PMM, Kleijnen J, , 2003. The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Med Res Methodol 3: 113.[Crossref] [Google Scholar]
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  • Received : 31 Dec 2013
  • Accepted : 15 Mar 2016
  • Published online : 06 Jul 2016

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