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
Review
. 2022 Nov;59(7):445-459.
doi: 10.1080/10408363.2022.2045250. Epub 2022 Mar 15.

Choice of SARS-CoV-2 diagnostic test: challenges and key considerations for the future

Affiliations
Review

Choice of SARS-CoV-2 diagnostic test: challenges and key considerations for the future

Fausto Baldanti et al. Crit Rev Clin Lab Sci. 2022 Nov.

Abstract

A plethora of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnostic tests are available, each with different performance specifications, detection methods, and targets. This narrative review aims to summarize the diagnostic technologies available and how they are best selected to tackle SARS-CoV-2 infection as the pandemic evolves. Seven key settings have been identified where diagnostic tests are being deployed: symptomatic individuals presenting for diagnostic testing and/or treatment of COVID-19 symptoms; asymptomatic individuals accessing healthcare for planned non-COVID-19-related reasons; patients needing to access emergency care (symptom status unknown); patients being discharged from healthcare following hospitalization for COVID-19; healthy individuals in both single event settings (e.g. airports, restaurants, hotels, concerts, and sporting events) and repeat access settings (e.g. workplaces, schools, and universities); and vaccinated individuals. While molecular diagnostics remain central to SARS-CoV-2 testing strategies, we have offered some discussion on the considerations for when other tools and technologies may be useful, when centralized/point-of-care testing is appropriate, and how the various additional diagnostics can be deployed in differently resourced settings. As the pandemic evolves, molecular testing remains important for definitive diagnosis, but increasingly widespread point-of-care testing is essential to the re-opening of society.

Keywords: PCR; SARS-CoV-2; antigen testing; molecular testing; point-of-care testing.

PubMed Disclaimer

Conflict of interest statement

The authors participated in an Advisory Board meeting that was sponsored by Roche Diagnostics. The authors declare no other conflicts of interest.

Figures

Figure 1.
Figure 1.
Testing strategies and considerations for the different diagnostic settings considered in this publication. Ag: antigen; CT: computed tomography; NAAT: nucleic acid amplification test; PCR: polymerase chain reaction.

References

    1. FIND . COVID-19 pipeline; 2021. [cited 2021 Nov 30]. Available from: https://www.finddx.org/covid-19/pipeline/
    1. European Centre for Disease Prevention and Control . Testing strategies for SARS-CoV-2; 2021. [cited 2021 Nov 30]. Available from: https://www.ecdc.europa.eu/en/covid-19/surveillance/testing-strategies
    1. WHO . Diagnostic testing for SARS-CoV-2; 2020. [cited 2021 Nov 30]. Available from: https://www.who.int/publications/i/item/diagnostic-testing-for-sars-cov-2
    1. Arevalo-Rodriguez I, Seron P, Buitrago-Garcia D, et al. . Recommendations for SARS-CoV-2/COVID-19 testing: a scoping review of current guidance. BMJ Open. 2021;11(1):e043004. - PMC - PubMed
    1. Faust L, Zimmer AJ, Kohli M, et al. . SARS-CoV-2 testing in low- and middle-income countries: availability and affordability in the private health sector. Microbes Infect. 2020;22(10):511–514. - PMC - PubMed

Publication types