Autor(es): Arroyo Sanchez, Maria Carmen ; Celeste, Beatriz Julieta ; Lauletta Lindoso, Jose Angelo ; Fujimori, Mahyumi ; Almeida, Roque Pacheco de ; Castelo Branco Fortaleza, Carlos Magno [UNESP] ; Druzian, Angelita Fernandes ; Freitas Lemos, Ana Priscila ; Andrade de Melo, Vanessa Campos ; Miranda Paniago, Anamaria Mello ; Queiroz, Igor Thiago ; Goto, Hiro
Data: 2020
Identificador Persistente: http://hdl.handle.net/11449/196919
Origem: Oasisbr
Made available in DSpace on 2020-12-10T20:00:23Z (GMT). No. of bitstreams: 0 Previous issue date: 2020-04-02
Ministry of Health, Brazil
Laboratorio de Investigacao Medica Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)
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 (TM) 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 (R) 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.
Univ Sao Paulo, Inst Med Trop, Lab Soroepidemiol & Imunobiol, Fac Med, Sao Paulo, SP, Brazil
Univ Sao Paulo, Fac Med, Dept Doencas Infecciosas & Parasitarias, Sao Paulo, SP, Brazil
Inst Infectol Emilio Ribas, Secretaria Estado Saude, Sao Paulo, SP, Brazil
Univ Fed Sergipe, Hosp Univ EBSERH, Dept Med Interna & Patol, Aracaju, SE, Brazil
Univ Estadual Paulista, Dept Doencas Trop & Diagnost Imagem, Botucatu, SP, Brazil
Univ Fed Mato Grosso, Hosp Univ Maria Aparecida Pedrossian, Campo Grande, MS, Brazil
Univ Fed Rio Grande do Norte, Hosp Univ Onofre Lopes, Natal, RN, Brazil
Hosp Giselda Trigueiro, Secretaria Estadual Seguranca Publ, Natal, RN, Brazil
Univ Fed Mato Grosso do Sul, Fac Med, Campo Grande, MS, Brazil
Univ Sao Paulo, Fac Med, Dept Med Prevent, Sao Paulo, SP, Brazil
Univ Estadual Paulista, Dept Doencas Trop & Diagnost Imagem, Botucatu, SP, Brazil
Ministry of Health, Brazil: 084727/2010
Laboratorio de Investigacao Medica Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo: LIM-38
