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| DOI | 10.1016/J.IJID.2020.05.098 | ||||
| Año | 2020 | ||||
| Tipo | artículo de investigación |
Citas Totales
Autores Afiliación Chile
Instituciones Chile
% Participación
Internacional
Autores
Afiliación Extranjera
Instituciones
Extranjeras
Objectives: In the context of the coronavirus disease 2019 (COVID-19) pandemic, the development and validation of rapid and easy-to-perform diagnostic methods are of high priority. This study was performed to evaluate a novel rapid antigen detection test (RDT) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in respiratory samples. Methods: The fluorescence immunochromatographic SARS-CoV-2 antigen test (Bioeasy Biotechnology Co., Shenzhen, China) was evaluated using universal transport medium with nasopharyngeal (NP) and oropharyngeal (OP) swabs from suspected COVID-19 cases. Diagnostic accuracy was determined in comparison to SARS-CoV-2 real-time (RT)-PCR. Results: A total of 127 samples were included; 82 were RT-PCR-positive. The median patient age was 38 years, 53.5% were male, and 93.7% were from the first week after symptom onset. Overall sensitivity and specificity were 93.9% (95% confidence interval 86.5–97.4%) and 100% (95% confidence interval 92.1–100%), respectively, with a diagnostic accuracy of 96.1% and Kappa coefficient of 0.9. Sensitivity was significantly higher in samples with high viral loads. Conclusions: The RDT evaluated in this study showed a high sensitivity and specificity in samples mainly obtained during the first week of symptoms and with high viral loads, despite the use of a non-validated sample material. The assay has the potential to become an important tool for early diagnosis of SARS-CoV-2, particularly in situations with limited access to molecular methods.
| Ord. | Autor | Género | Institución - País |
|---|---|---|---|
| 1 | PORTE-TORRES, LORENA ISABEL | Mujer |
Universidad del Desarrollo - Chile
|
| 2 | Legarraga, Paulette | Mujer |
Universidad del Desarrollo - Chile
|
| 3 | VOLLRATH-REYES, VALESKA | Mujer |
Universidad del Desarrollo - Chile
|
| 4 | AGUILERA-SANHUEZA, XIMENA PAZ | Mujer |
Universidad del Desarrollo - Chile
Clínica Alemana - Chile |
| 5 | MUNITA-SEPULVEDA, JOSE MANUEL | Hombre |
Universidad del Desarrollo - Chile
Núcleo Milenio para la Investigación Colaborativa en Resistencia Antimicrobiana - Chile Millennium Initiat Collaborat Res Bacterial Resis - Chile Clínica Alemana - Chile |
| 6 | ARAOS-BRALIC, RAFAEL IGNACIO | Hombre |
Universidad del Desarrollo - Chile
Núcleo Milenio para la Investigación Colaborativa en Resistencia Antimicrobiana - Chile Millennium Initiat Collaborat Res Bacterial Resis - Chile Clínica Alemana - Chile |
| 7 | Pizarro, Gabriel | Hombre |
Universidad del Desarrollo - Chile
|
| 8 | VIAL-CLARO, PABLO AGUSTIN | Hombre |
Universidad del Desarrollo - Chile
Clínica Alemana - Chile |
| 9 | IRURETAGOYENA-BRUCE, MIRENTXU INES | - |
Universidad del Desarrollo - Chile
|
| 10 | Dittrich, Sabine | Mujer |
Foundation for Innovative New Diagnostics, Switzerland - Suiza
Nuffield Department of Medicine - Reino Unido Fdn Innovat New Diagnost FIND - Suiza UNIV OXFORD - Reino Unido |
| 11 | Weitzel, Thomas | Hombre |
Universidad del Desarrollo - Chile
Clínica Alemana - Chile |