Performance of rK39-based immunochromatographic rapid diagnostic test for serodiagnosis of visceral leishmaniasis using whole blood, serum and oral fluid

dc.contributor.authorSanchez, Maria Carmen Arroyo
dc.contributor.authorCeleste, Beatriz Julieta
dc.contributor.authorLindoso, José Angelo Lauletta
dc.contributor.authorFujimori, Mahyumi
dc.contributor.authorAlmeida, Roque Pacheco de
dc.contributor.authorFortaleza, Carlos Magno Castelo Branco
dc.contributor.authorDruzian, Angelita Fernandes
dc.contributor.authorLemos, Ana Priscila Freitas
dc.contributor.authorMelo, Vanessa Campos Andrade de
dc.contributor.authorPaniago, Anamaria Mello Miranda
dc.contributor.authorSilva, Igor Thiago Borges de Queiroz e
dc.contributor.authorGoto, Hiro
dc.date.accessioned2021-01-25T18:02:01Z
dc.date.available2021-01-25T18:02:01Z
dc.date.issued2020-04-02
dc.description.resumoBackground: The development of rK39-based immunochromatographic rapid diagnostic tests represents an important advance for serodiagnosis of visceral leishmaniasis, being cheap and easy to use at the point of care (POC). Although the use of rK39 have considerably improved the sensitivity and specificity of serological tests compared with total antigens, great variability in sensitivity and specificity was reported. This study aimed at the evaluation of “Kalazar Detect™ Rapid Test, Whole Blood” (Kalazar Detect RDT) for Visceral Leishmaniasis (VL) diagnosis using oral fluid, whole blood and serum specimens collected at different endemic areas of VL of Brazil. Methodology: To evaluate Kalazar Detect RDT, oral fluid, whole blood and serum specimens from 128 VL patients, 85 healthy individuals, 22 patients with possible cross-reactivity diseases and 20 VL/aids coinfected patients were collected and assayed at the POC. Principal findings and conclusions: The performance of Kalazar Detect RDT in whole blood and serum was similar; however, using oral fluid, the sensitivity was low. Particularly in samples from the city of Natal, Rio Grande do Norte state in Northeastern Brazil, we observed low sensitivity, 80.0% (95% CI: 62.7–90.5), using whole blood and serum, and poor sensitivity, 43.3% (95% CI: 27.4–60.8) with oral fluid. Those values were much lower than in the other regions, where sensitivity ranged from 92.7–96.3% in whole blood and serum, and 80.0–88.9% in oral fluid. Besides, in VL/aids coinfected patients, lower sensitivity was achieved compared with VL patients. In samples from Natal, the sensitivity was 0.0% (95% CI: 0.0–49.0) and 25.0% (95% CI: 4.6–69.9), using oral fluid and serum/whole blood, respectively; in samples from the other regions, the sensitivity ranged from 40.0–63.6% and 80.0–81.8%, respectively. As for specificity, high values were observed across the fluids, 100.0% (95% CI: 96.5–100.0) in whole blood, 96.3% (95% CI: 90.8–98.5) in serum, and 95.3% (95% CI: 89.5–98.0) in oral fluid; across localities, specificity ranged from 85.7–100.0%. Serum samples sent by the collaborating centers to Instituto de Medicina Tropical (n = 250) were tested by Kalazar Detect RDT, Direct Agglutination Test, Indirect immunofluorescence assay, Enzyme-linked immunosorbent assay, and IT-Leish® RDT. The regional difference in the performance of rK39-based RDT and lower sensitivity in Leishmania/HIV coinfected patients raise concern on the routine use of these products for the diagnosis of VLpt_BR
dc.identifier.citationSANCHEZ, Maria Carmen Arroyo; CELESTE, Beatriz Julieta; LINDOSO, José Angelo Lauletta; FUJIMORI, Mahyumi; ALMEIDA, Roque Pacheco de; FORTALEZA, Carlos Magno Castelo Branco; DRUZIAN, Angelita Fernandes; LEMOS, Ana Priscila Freitas; MELO, Vanessa Campos Andrade de; PANIAGO, Anamaria Mello Miranda; SILVA, Igor Thiago Borges de Queiroz e; GOTO, Hiro. Performance of rK39-based immunochromatographic rapid diagnostic test for serodiagnosis of visceral leishmaniasis using whole blood, serum and oral fluid. Plos One, [s. l.], v. 15, n. 4, p. 1-19, 02 abr. 2020. Disponível em: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0230610. Acesso em: 20 jan. 2021. http://dx.doi.org/10.1371/journal.%20pone.0230610.pt_BR
dc.identifier.doi10.1371/journal.%20pone.0230610
dc.identifier.issn1932-6203 (online)
dc.identifier.urihttps://repositorio.ufrn.br/handle/123456789/31309
dc.languageenpt_BR
dc.publisherPublic Library of Sciencept_BR
dc.rightsAttribution 3.0 Brazil*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/br/*
dc.subjectAntibodies, Protozoanpt_BR
dc.subjectFluorescent Antibody Technique, Indirectpt_BR
dc.subjectProtozoan Proteinspt_BR
dc.subjectSerologic Testspt_BR
dc.subjectLeishmaniasis, Visceralpt_BR
dc.subjectDiagnostic Tests, Routinept_BR
dc.titlePerformance of rK39-based immunochromatographic rapid diagnostic test for serodiagnosis of visceral leishmaniasis using whole blood, serum and oral fluidpt_BR
dc.typearticlept_BR

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