| Revue: | Memorias do Instituto Oswaldo Cruz |
| Base de datos: | PERIÓDICA |
| Número de sistema: | 000420022 |
| ISSN: | 0074-0276 |
| Autores: | Prado, Paulo Sousa1 Almeida-Júnior, José Teófilo Duarte1 Abreu, Lanna Takada de1 Silva, Cristina Gabriel2 Souza, Larissa da Costa2 Gomes, Marizoneide Cavalcante2 Mendes, Lucinda Malheiros Teixeira2 Santos, Eliane Maria dos2 Romero, Gustavo Adolfo Sierra1 |
| Instituciones: | 1Universidade de Brasilia, Nucleo de Medicina Tropical, Brasilia, Distrito Federal. Brasil 2Laboratorio Central de Saude Publica, Brasilia, Distrito Federal. Brasil |
| Año: | 2018 |
| Volumen: | 113 |
| Número: | 8 |
| País: | Brasil |
| Idioma: | Inglés |
| Tipo de documento: | Artículo |
| Enfoque: | Experimental, aplicado |
| Resumen en inglés | The diagnosis of dengue is complex. Until recently, only specialised laboratories were able to confirm dengue infection. However, this has changed with the newly available immunochromatographic rapid tests. Early diagnosis is of great interest, and point-of-care rapid tests have been increasingly used in Brazil. Most of those tests have not undergone validation in the Brazilian population. In this context, we decided to evaluate a rapid test introduced in the Federal District (FD). OBJECTIVES To estimate the accuracy and reliability of the SD Bioeasy Dengue Duo rapid test and its components to detect dengue infections in a consecutive sample of symptomatic residents in the FD, Brazil. METHODS In total, 1353 venous blood samples were collected between 2013 and 2014. Two hundred and six positive samples (cases) and 246 negative samples (non cases) were required for sensitivity and specificity estimation, respectively; for agreement evaluation, we used 401 samples. The reference standard used was a composite of MAC-ELISA, virus isolation and real-time polymerase chain reaction (RT-qPCR). The evaluation was conducted prospectively under field conditions in the public health units of the FD. FINDINGS The results for the overall accuracy of the rapid test (NS1/IgM combined) showed 76% sensitivity and 98% specificity. The sensitivity for the NS1 component (67%) was better than that for the IgM component (35%). The positive likelihood ratio was 46, and the negative likelihood ratio was 0.24. The reliability of the test (NS1/IgM combined) demonstrated crude agreement of 98% (Kappa index 0.94). MAIN CONCLUSIONS The present phase III, large-scale validation study demonstrates that the rapid test SD Bioeasy Dengue Duo has moderate sensitivity (NS1/IgM combined) and high specificity. Therefore, the test is useful in confirming the diagnosis of dengue, but not enough to rule out the diagnosis |
| Disciplinas: | Medicina |
| Palabras clave: | Microbiología, Diagnóstico, Dengue, Pruebas diagnósticas, Inmunocromatografía, Exactitud |
| Keyword: | Microbiology, Diagnosis, Dengue, Diagnostic tests, Immunochromatography, Accuracy |
| Texte intégral: | Texto completo (Ver HTML) |
