Evaluation of a novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples.
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.
['Porte|Lorena|L|', 'Legarraga|Paulette|P|', 'Vollrath|Valeska|V|', 'Aguilera|Ximena|X|', 'Munita|José M|JM|', 'Araos|Rafael|R|', 'Pizarro|Gabriel|G|', 'Vial|Pablo|P|', 'Iruretagoyena|Mirentxu|M|', 'Dittrich|Sabine|S|', 'Weitzel|Thomas|T|']
D000293:Adolescent D000328:Adult D000368:Aged D000369:Aged, 80 and over D000073640:Betacoronavirus D000086382:COVID-19 D000086742:COVID-19 Testing D000086663:COVID-19 Vaccines D002648:Child D002675:Child, Preschool D019411:Clinical Laboratory Techniques D018352:Coronavirus Infections D005260:Female D006801:Humans D007223:Infant D008297:Male D008875:Middle Aged D009305:Nasopharynx D058873:Pandemics D011024:Pneumonia, Viral D000086402:SARS-CoV-2 D012680:Sensitivity and Specificity D019562:Viral Load D055815:Young Adult
Diagnosis SARS-CoV-2 Coronavirus COVID-19 Antigen Rapid diagnostic test