Performance assessment of a new indirect rapid diagnostic test for plague detection in humans and other mammalian hosts.

Autor: Bezerra MF; Departamento de Microbiologia, Instituto Aggeu Magalhães; FIOCRUZ, Recife, Brazil., Dos Santos WJT; Instituto de Tecnologia em Imunobiológicos, Bio-Manguinhos; FIOCRUZ, Rio de Janeiro, Brazil., Rocha IV; Departamento de Microbiologia, Instituto Aggeu Magalhães; FIOCRUZ, Recife, Brazil., Nadaes NR; Instituto de Tecnologia em Imunobiológicos, Bio-Manguinhos; FIOCRUZ, Rio de Janeiro, Brazil., Dantas-Torres F; Departamento de Imunologia, Instituto Aggeu Magalhães; FIOCRUZ, Recife, Brazil., Sales KGDS; Departamento de Imunologia, Instituto Aggeu Magalhães; FIOCRUZ, Recife, Brazil., de Melo Neto OP; Departamento de Microbiologia, Instituto Aggeu Magalhães; FIOCRUZ, Recife, Brazil., Sobreira M; Departamento de Microbiologia, Instituto Aggeu Magalhães; FIOCRUZ, Recife, Brazil., Silva ED; Instituto de Tecnologia em Imunobiológicos, Bio-Manguinhos; FIOCRUZ, Rio de Janeiro, Brazil., de Almeida AMP; Departamento de Microbiologia, Instituto Aggeu Magalhães; FIOCRUZ, Recife, Brazil., Reis CRS; Departamento de Microbiologia, Instituto Aggeu Magalhães; FIOCRUZ, Recife, Brazil. Electronic address: christian.reis@fiocruz.br.
Jazyk: angličtina
Zdroj: Acta tropica [Acta Trop] 2022 Jul; Vol. 231, pp. 106427. Date of Electronic Publication: 2022 Mar 24.
DOI: 10.1016/j.actatropica.2022.106427
Abstrakt: Plague is a flea-borne zoonosis that affects a wide range of mammals and still causes outbreaks in human populations yearly across several countries. While crucial for proper treatment, early diagnosis is still a major challenge in low- and middle-income countries due to poor access to laboratory infrastructure in rural areas. To tackle this issue, we developed and evaluated a new Fraction 1 capsular antigen (F1)-based rapid diagnostic test (RDT) as an alternative method for plague serological diagnosis and surveillance in humans and other mammals. In this study, 187 serum samples from humans, dogs, rodents and rabbits were retrospectively assessed using the plague RDT method. To calculate its performance, results were compared to those obtained by traditional hemagglutination (HA) and ELISA, which are well-established methods in the plague routine serodiagnosis. Remarkably, the results from RDT were in full agreement with those from the ELISA and HA assays, resulting in 100% (CI 95% = 95.5-100%) of sensitivity and 100% (CI 95% = 96.6-100%) of specificity. Accordingly, the Cohen's Kappa test coefficient was 1.0 (almost perfect agreement). Moreover, the RDT showed no cross-reaction when tested with sera from individuals positive to other pathogens, such as Y. pseudotuberculosis, Yersinia enterocolitica, Anaplasma platys, Ehrlichia canis and Leishmania infantum. Although preliminary, this study brings consistent proof-of-concept results with high performance of the Plague RDT when compared to HA and ELISA. Although further human and animal population-based studies will be necessary to validate these findings, the data presented here show that the plague RDT is highly sensitive and specific, polyvalent to several mammal species and simple to use in field surveillance or point-of-care situations with instant results.
(Copyright © 2022. Published by Elsevier B.V.)
Databáze: MEDLINE
Externí odkaz: