• Lorena Porte, Paulette Legarraga, Valeska Vollrath, Ximena Aguilera, José M Munita, Rafael Araos, Gabriel Pizarro, Pablo Vial, Mirentxu Iruretagoyena, Sabine Dittrich, and Thomas Weitzel.
• Laboratorio Clínico, Clínica Alemana, Universidad del Desarrollo, Santiago, Chile. Electronic address: lporte@alemana.cl.
• Int. J. Infect. Dis. 2020 Oct 1; 99: 328-333.

ObjectivesIn 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.MethodsThe 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.ResultsA 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.ConclusionsThe 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.Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.

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