دورية أكاديمية
Performance of rK39-based immunochromatographic rapid diagnostic test for serodiagnosis of visceral leishmaniasis using whole blood, serum and oral fluid.
| العنوان: | Performance of rK39-based immunochromatographic rapid diagnostic test for serodiagnosis of visceral leishmaniasis using whole blood, serum and oral fluid. |
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| المؤلفون: | Sanchez MCA; Laboratório de Soroepidemiologia e Imunobiologia, Instituto de Medicina Tropical da Faculdade de Medicina, Universidade de São Paulo, SP, Brazil., Celeste BJ; Laboratório de Soroepidemiologia e Imunobiologia, Instituto de Medicina Tropical da Faculdade de Medicina, Universidade de São Paulo, SP, Brazil., Lindoso JAL; Departamento de Doenças Infecciosas e Parasitárias, Faculdade de Medicina, Universidade de São Paulo, SP, Brazil.; Instituto de Infectologia Emílio Ribas, Secretaria de Estado da Saúde, São Paulo, SP, Brazil., Fujimori M; Laboratório de Soroepidemiologia e Imunobiologia, Instituto de Medicina Tropical da Faculdade de Medicina, Universidade de São Paulo, SP, Brazil., de Almeida RP; Departamento de Medicina Interna e Patologia, Hospital Universitário/EBSERH, Universidade Federal de Sergipe, Aracaju, SE, Brazil., Fortaleza CMCB; Departamento de Doenças Tropicais e Diagnóstico por Imagem, Universidade Estadual Paulista Júlio de Mesquita Filho, Botucatu, SP, Brazil., Druzian AF; Hospital Universitário Maria Aparecida Pedrossian, Universidade Federal de Mato Grosso do Sul, Campo Grande, MS, Brazil., Lemos APF; Hospital Universitário Onofre Lopes, Universidade Federal do Rio Grande do Norte, Natal, RN, Brazil., de Melo VCA; Hospital Giselda Trigueiro, Secretaria Estadual da Segurança Pública, Natal, RN, Brazil., Miranda Paniago AM; Faculdade de Medicina, Universidade Federal de Mato Grosso do Sul, Campo Grande, MS, Brazil., Queiroz IT; Hospital Giselda Trigueiro, Secretaria Estadual da Segurança Pública, Natal, RN, Brazil., Goto H; Laboratório de Soroepidemiologia e Imunobiologia, Instituto de Medicina Tropical da Faculdade de Medicina, Universidade de São Paulo, SP, Brazil.; Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de São Paulo, SP, Brazil. |
| المصدر: | PloS one [PLoS One] 2020 Apr 02; Vol. 15 (4), pp. e0230610. Date of Electronic Publication: 2020 Apr 02 (Print Publication: 2020). |
| نوع المنشور: | Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: San Francisco, CA : Public Library of Science |
| مواضيع طبية MeSH: | Body Fluids/*chemistry , Chromatography, Affinity/*methods , Diagnostic Tests, Routine/*methods , Leishmania/*isolation & purification , Leishmaniasis, Visceral/*diagnosis , Protozoan Proteins/*immunology , Serologic Tests/*methods, Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antibodies, Protozoan/blood ; Antibodies, Protozoan/immunology ; Antigens, Protozoan/immunology ; Brazil/epidemiology ; Child ; Child, Preschool ; Female ; Fluorescent Antibody Technique, Indirect ; Humans ; Infant ; Leishmaniasis, Visceral/blood ; Leishmaniasis, Visceral/epidemiology ; Male ; Middle Aged ; Point-of-Care Systems ; Young Adult |
| مستخلص: | Background: 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 VL. Competing Interests: The authors have declared that no competing interests exist. |
| التعليقات: | Erratum in: PLoS One. 2020 Apr 29;15(4):e0232727. (PMID: 32348357) |
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| المشرفين على المادة: | 0 (Antibodies, Protozoan) 0 (Antigens, Protozoan) 0 (Protozoan Proteins) |
| تواريخ الأحداث: | Date Created: 20200403 Date Completed: 20200707 Latest Revision: 20200707 |
| رمز التحديث: | 20240628 |
| مُعرف محوري في PubMed: | PMC7117722 |
| DOI: | 10.1371/journal.pone.0230610 |
| PMID: | 32240188 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1932-6203 |
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| DOI: | 10.1371/journal.pone.0230610 |