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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.

Original publication

DOI

10.1016/j.ijid.2020.05.098

Type

Journal

International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases

Publication Date

10/2020

Volume

99

Pages

328 - 333

Addresses

Laboratorio Clínico, Clínica Alemana, Universidad del Desarrollo, Santiago, Chile. Electronic address: lporte@alemana.cl.

Keywords

Nasopharynx, Humans, Pneumonia, Viral, Coronavirus Infections, Clinical Laboratory Techniques, Viral Load, Sensitivity and Specificity, Adolescent, Adult, Aged, Aged, 80 and over, Middle Aged, Child, Child, Preschool, Infant, Female, Male, Young Adult, Pandemics, Betacoronavirus, COVID-19, SARS-CoV-2, COVID-19 Testing, COVID-19 Vaccines