Recombinant protein KR95 as an alternative for serological diagnosis of human visceral leishmaniasis in the Americas

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0
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article
Data de publicação
2023
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Scopus
Web of Science
PubMed
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PUBLIC LIBRARY SCIENCE
Autores
ALMEIDA, Roque Pacheco de
COSTA, Carlos Henrique Nery
CRUZ, Alda Maria da
DRUZIAN, Angelita Fernandes
DUTHIE, Malcolm Scott
FORTALEZA, Carlos Magno Castelo Branco
Citação
PLOS ONE, v.18, n.3, 2023
Projetos de Pesquisa
Unidades Organizacionais
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Resumo
In the Americas, visceral leishmaniasis (VL) is caused by the protozoan Leishmania infantum, leading to death if not promptly diagnosed and treated. In Brazil, the disease reaches all regions, and in 2020, 1,933 VL cases were reported with 9.5% lethality. Thus, an accurate diagnosis is essential to provide the appropriate treatment. Serological VL diagnosis is based mainly on immunochromatographic tests, but their performance may vary by location, and evaluation of diagnostic alternatives is necessary. In this study, we aimed to evaluate the performance of ELISA with the scantily studied recombinant antigens, K18 and KR95, comparing their performance with the already known rK28 and rK39. Sera from parasitologically confirmed symptomatic VL patients (n = 90) and healthy endemic controls (n = 90) were submitted to ELISA with rK18 and rKR95. Sensitivity (95% CI) was, respectively, 83.3% (74.2-89.7) and 95.6% (88.8-98.6), and specificity (95% CI) was 93.3% (85.9-97.2) and 97.8% (91.8-99.9). For validation of ELISA with the recombinant antigens, we included samples from 122 VL patients and 83 healthy controls collected in three regions in Brazil (Northeast, Southeast, and Midwest). When comparing the results obtained with the VL patients' samples, significantly lower sensitivity was obtained by rK18-ELISA (88.5%, 95% CI: 81.5-93.2) compared with rK28-ELISA (95.9%, 95% CI: 90.5-98.5), but the sensitivity was similar comparing rKR95-ELISA (95.1%, 95% CI: 89.5-98.0), rK28-ELISA (95.9%, 95% CI: 90.5-98.5), and rK39-ELISA (94.3%, 95% CI: 88.4-97.4). Analyzing the specificity, it was lowest with rK18-ELISA (62.7%, 95% CI: 51.9-72.3) with 83 healthy control samples. Conversely, higher and similar specificity was obtained by rKR95-ELISA (96.4%, 95% CI: 89.5-99.2), rK28-ELISA (95.2%, 95% CI: 87.9-98.5), and rK39-ELISA (95.2%, 95% CI: 87.9-98.5). There was no difference in sensitivity and specificity across localities. Cross-reactivity assessment, performed with sera of patients diagnosed with inflammatory disorders and other infectious diseases, was 34.2% with rK18-ELISA and 3.1% with rKR95-ELISA. Based on these data, we suggest using recombinant antigen KR95 in serological assays for VL diagnosis.
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https://observatorio.fm.usp.br/handle/OPI/54009
Referências
  1. Sanchez MCA, 2020, PLOS ONE, V15, DOI 10.1371/journal.pone.0230610
  2. Banoo S, 2006, NAT REV MICROBIOL, pS20, DOI 10.1038/nrmicro1570
  3. Boarino A, 2005, CLIN DIAGN LAB IMMUN, V12, P647, DOI 10.1128/CDLI.12.5.647-653.2005
  4. Boelaert M., 2007, Nature Reviews Microbiology, pS30, DOI 10.1038/nrmicro1766
  5. BURNS JM, 1993, P NATL ACAD SCI USA, V90, P775, DOI 10.1073/pnas.90.2.775
  6. Burza S, 2018, LANCET, V392, P951, DOI 10.1016/S0140-6736(18)31204-2
  7. CDC-DPDx Laboratory Identification of Parasites of Public Health Concern, 2017, LEISHMANIASIS
  8. Chappuis F, 2007, NAT REV MICROBIOL, V5, P873, DOI 10.1038/nrmicro1748
  9. Chappuis F, 2006, BMJ-BRIT MED J, V333, P723, DOI 10.1136/bmj.38917.503056.7C
  10. Cota GF, 2013, AM J TROP MED HYG, V89, P570, DOI 10.4269/ajtmh.13-0239
  11. Cruz I, 2022, ASSESSMENT CROSS REA, P865
  12. Cunningham J, 2012, CLIN INFECT DIS, V55, P1312, DOI 10.1093/cid/cis716
  13. Deniau M, 2003, ANN TROP MED PARASIT, V97, P115, DOI 10.1179/000349803225002598
  14. dos Santos ARR, 2019, MEM I OSWALDO CRUZ, V114, DOI 10.1590/0074-02760180405
  15. Figueiredo MM, 2021, J IMMUNOL RES, V2021, DOI 10.1155/2021/5568077
  16. Fleiss J. L., 2013, STAT METHODS RATES P
  17. Freire ML, 2019, PLOS NEGLECT TROP D, V13, DOI 10.1371/journal.pntd.0007484
  18. Fujimori M, 2021, MEM I OSWALDO CRUZ, V116, DOI 10.1590/0074-02760200428
  19. Georgiadou SP, 2015, J TRANSL INTERN MED, V3, P43, DOI 10.1515/jtim-2015-0002
  20. Goto Y, 2006, INFECT IMMUN, V74, P3939, DOI 10.1128/IAI.00101-06
  21. Hasker E, 2013, PLOS NEGLECT TROP D, V7, DOI 10.1371/journal.pntd.0002053
  22. Herwaldt BL, 1999, LANCET, V354, P1191, DOI 10.1016/S0140-6736(98)10178-2
  23. HO EA, 1948, T ROY SOC TROP MED H, V41, P629, DOI 10.1016/S0035-9203(48)90458-1
  24. Kuhne V, 2019, PLOS NEGLECT TROP D, V13, DOI 10.1371/journal.pntd.0007658
  25. LANDIS JR, 1977, BIOMETRICS, V33, P159, DOI 10.2307/2529310
  26. de Assis TSM, 2012, TROP MED INT HEALTH, V17, P1202, DOI 10.1111/j.1365-3156.2012.03064.x
  27. Mohammed Rezika, 2022, PLOS NEGLECT TROP D
  28. Mukhtar M, 2015, T ROY SOC TROP MED H, V109, P594, DOI 10.1093/trstmh/trv060
  29. PAHO/WHO, LEISHMANIASIS
  30. Pattabhi S, 2010, PLOS NEGLECT TROP D, V4, DOI 10.1371/journal.pntd.0000822
  31. Pedras MJ, 2008, T ROY SOC TROP MED H, V102, P172, DOI 10.1016/j.trstmh.2007.11.004
  32. Porrozzi R, 2007, CLIN VACCINE IMMUNOL, V14, P544, DOI 10.1128/CVI.00420-06
  33. Ruiz-Postigo J.A., 2021, WHO WEEKLY EPIDEMIOL, V35, P19
  34. Sinan/SVS/MS, 2020, CAS CONF LEISHM VISC
  35. Sinan/SVS/MS, 2021, TAX LET LEISHM VISC
  36. Srivastava P, 2011, T ROY SOC TROP MED H, V105, P1, DOI 10.1016/j.trstmh.2010.09.006
  37. Sundar S, 1998, LANCET, V351, P563, DOI 10.1016/S0140-6736(97)04350-X
  38. Thakur Shivani, 2020, J Parasit Dis, V44, P253, DOI 10.1007/s12639-020-01212-w
  39. Vallur AC, 2015, EUR J CLIN MICROBIOL, V34, P679, DOI 10.1007/s10096-014-2282-9
  40. Vallur AC, 2016, J CLIN MICROBIOL, V54, P1025, DOI 10.1128/JCM.02620-15
  41. World Health Organization, LEISHM KEY FACTS
  42. ZIJLSTRA EE, 1992, T ROY SOC TROP MED H, V86, P505, DOI 10.1016/0035-9203(92)90086-R

Coleções
Artigos e Materiais de Revistas Científicas - FM/MPR
Artigos e Materiais de Revistas Científicas - IMT
Artigos e Materiais de Revistas Científicas - LIM/38
Artigos e Materiais de Revistas Científicas - LIM/49