Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Comparative Study
. 2021 Jun:107:215-218.
doi: 10.1016/j.ijid.2021.04.072. Epub 2021 Apr 27.

Comparative diagnostic performance of rapid antigen detection tests for COVID-19 in a hospital setting

Bianca Bruzzone  1 , Vanessa De Pace  1 , Patrizia Caligiuri  1 , Valentina Ricucci  1 , Giulia Guarona  1 , Beatrice M Pennati  2 , Simona Boccotti  3 , Andrea Orsi  3 , Alexander Domnich  4 , Giorgio Da Rin  5 , Giancarlo Icardi  3
Affiliations
Comparative Study

Comparative diagnostic performance of rapid antigen detection tests for COVID-19 in a hospital setting

Bianca Bruzzone et al. Int J Infect Dis. 2021 Jun.

Abstract

Background: The availability of accurate and rapid diagnostic tools for COVID-19 is essential for tackling the ongoing pandemic. Our study aimed to quantify the performance of available antigen-detecting rapid diagnostic tests (Ag-RDTs) in a real-world hospital setting.

Methods: In this retrospective analysis, the diagnostic performance of 7 Ag-RDTs was compared with real-time reverse transcription quantitative polymerase chain reaction assay in terms of sensitivity, specificity and expected predictive values.

Results: A total of 321 matched Ag-RDTreal-time reverse transcription quantitative polymerase chain reaction samples were analyzed retrospectively. The overall sensitivity and specificity of the Ag-RDTs was 78.7% and 100%, respectively. However, a wide range of sensitivity estimates by brand (66.0%-93.8%) and cycle threshold (Ct) cut-off values (Ct <25: 96.2%; Ct 30-35: 31.1%) was observed. The optimal Ct cut-off value that maximized sensitivity was 29.

Conclusions: The routine use of Ag-RDTs may be convenient in moderate-to-high intensity settings when high volumes of specimens are tested every day. However, the diagnostic performance of the commercially available tests may differ substantially.

Keywords: COVID-19; Italy; Rapid antigen detection test; SARS-CoV-2.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Distribution of the cycle threshold values of RT-qPCR positive samples, by gene region. Ct: cycle threshold; RdRp: RNA-dependent RNA-polymerase; RT-qPCR: reverse transcription quantitative polymerase chain reaction.
See this image and copyright information in PMC

References

    1. Bullard J., Dust K., Funk D., Strong J.E., Alexander D., Garnett L., et al. Predicting infectious severe acute respiratory syndrome coronavirus 2 from diagnostic samples. Clin Infect Dis. 2020;71(10):2663–2666. doi: 10.1093/cid/ciaa638. - DOI - PMC - PubMed
    1. Dinnes J., Deeks J.J., Berhane S., Taylor M., Adriano A., Davenport C., et al. Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev. 2021;3 doi: 10.1002/14651858.CD013705.pub2. PMID: 33760236. - DOI - PMC - PubMed
    1. European Centre for Disease Prevention and Control . 2020. Options for the use of rapid antigen tests for COVID-19 in the EU/EEA and the UK. 19 November 2020. Available from: https://www.ecdc.europa.eu/sites/default/files/documents/Options-use-of-.... [Accessed 29 March 2021]
    1. Foundation for Innovative New Diagnostics (FIND) 2020. Comparative evaluation of lateral flow assay tests that directly detect antigens of SARS-CoV-2. Available from: https://www.finddx.org/wp-content/uploads/2020/04/20200421-COVID-Ag-RDT-.... [Accessed 29 March 2021]
    1. Greene C.J., Burleson S.L., Crosby J.C., Heimann M.A., Pigott D.C. Coronavirus disease 2019: International public health considerations. J Am Coll Emerg Phys Open. 2020;1(February (2)):70–77. doi: 10.1002/emp2.12040. - DOI - PMC - PubMed

Publication types

Substances