Evaluation of a novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples
Lorena Porte, Paulette Legarraga, Valeska Vollrath, Ximena Aguilera, José M Munita, Rafael Araos, Gabriel Pizarro, Pablo Vial, Mirentxu Iruretagoyena, Sabine Dittrich, Thomas Weitzel, Lorena Porte, Paulette Legarraga, Valeska Vollrath, Ximena Aguilera, José M Munita, Rafael Araos, Gabriel Pizarro, Pablo Vial, Mirentxu Iruretagoyena, Sabine Dittrich, Thomas Weitzel
Abstract
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.
Keywords: Antigen; COVID-19; Coronavirus; Diagnosis; Rapid diagnostic test; SARS-CoV-2.
Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.
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References
- CDC (Centers for Disease Control and Prevention), Respiratory Viruses Branch, Division of Viral Diseases. Real-Time RT-PCR Panel for Detection 2019-Novel Coronavirus. Instructions for Use. 2020. , 2020 (accessed 15 May 2020).
- Che X.Y., Hao W., Wang Y., Di B., Yin K., Xu Y.C. Nucleocapsid protein as early diagnostic marker for SARS. Emerg Infect Dis. 2004;10:1947–1949.
- CLSI . Clinical and Laboratory Standards Institute; Wayne, PA: 2008. User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline-Second Edition. CLSI document EP12-A2.
- Corman V.M., Landt O., Kaiser M Molenkamp R., Meijer A., Chu D.K.W. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill. 2020;25(3) doi: 10.2807/1560-7917.ES.2020.25.3.2000045.
- Diao B., Wen K., Chen J., Liu Y., Yuan Z., Han C. 2020. Diagnosis of acute respiratory syndrome coronavirus 2 infection by detection of nucleocapsid protein. Preprint at.
- ECDC. Coronavirus disease 2019 (COVID-19) pandemic: increased transmission in the EU/EEA and the UK – seventh update, 2020. Stockholm: 2020. (accessed 15 May 2020).
- Commission European. Communication from the Commission: Guidelines on COVID-19 in vitro diagnostic tests and their performance (2020/C 122 I/01) Official Journal of the European Union. 2020 (accessed 13 May 2020)
- FIND (Foundation for Innovative New Diagnostics). SARS-CoV-2 diagnostic pipeline. 2020 (continuously updated). (accessed 15 May 2020).
- Nguyen T., Duong Bang D., Wolff A. Novel Coronavirus Disease (COVID-19): Paving the Road for Rapid Detection and Point-of-Care Diagnostics. Micromachines (Basel) 2020 pii:E306.
- Patel R., Babady E., Theel E.S., Storch G.A., Pinsky B.A., St George K. Report from the American Society for Microbiology COVID-19 International Summit, 23 March 2020: Value of Diagnostic Testing for SARS-CoV-2/COVID-19. mBio. 2020 pii:e00722-20.
- Weitzel T., Rodríguez F., Noriega L.M., Marcotti A., Duran L., Palavecino C. Hepatitis B and C virus infection among HIV patients within the public and private healthcare systems in Chile: A cross-sectional serosurvey. PLOS One. 2020;15
- WHO (World Health Organisation) A coordinated Global Research Roadmap. , 2020a (accessed 15 May 2020).
- WHO (World Health Organisation) Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases. Interim guidance. 2020. , 2020b (accessed 15 May 2020).
- WHO (World Health Organisation) Laboratory testing strategy recommendations for COVID-19. Interim guidance. 2020. , 2020c (accessed 15 May 2020).
- WHO. Laboratory biosafety guidance related to the novel coronavirus (2019-nCoV). Interim guidance. 2020. , 2020d (accessed 15 May 2020).
- Wölfel R., Corman V.M., Guggemos, Seilmaier W.M., Zange S., Mueller M.A. Virological assessment of hospitalized patients with COVID-2019. Nature. 2020;581:465–469.
- Zou L., Ruan F., Huang M., Liang L., Huang H., Hong Z. SARS-CoV-2 Viral load in upper respiratory specimens of infected patients. N Engl J Med. 2020;382:1177–1179.
Source: PubMed