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
Meta-Analysis
. 2021 Nov;26(45):2001675.
doi: 10.2807/1560-7917.ES.2021.26.45.2001675.

Meta-analysis of the clinical performance of commercial SARS-CoV-2 nucleic acid and antibody tests up to 22 August 2020

Ivo Van Walle  1   2 , Katrin Leitmeyer  1 , Eeva K Broberg  1 ; European COVID-19 microbiological laboratories group  3
Collaborators, Affiliations
Meta-Analysis

Meta-analysis of the clinical performance of commercial SARS-CoV-2 nucleic acid and antibody tests up to 22 August 2020

Ivo Van Walle et al. Euro Surveill. 2021 Nov.

Abstract

BackgroundReliable testing for SARS-CoV-2 is key for the management of the COVID-19 pandemic.AimWe estimate diagnostic accuracy for nucleic acid and antibody tests 5 months into the COVID-19 pandemic, and compare with manufacturer-reported accuracy.MethodsWe reviewed the clinical performance of SARS-CoV-2 nucleic acid and antibody tests based on 93,757 test results from 151 published studies and 20,205 new test results from 12 countries in the European Union and European Economic Area (EU/EEA).ResultsPooling the results and considering only results with 95% confidence interval width ≤ 5%, we found four nucleic acid tests, including one point-of-care test and three antibody tests, with a clinical sensitivity ≥ 95% for at least one target population (hospitalised, mild or asymptomatic, or unknown). Nine nucleic acid tests and 25 antibody tests, 12 of them point-of-care tests, had a clinical specificity of ≥ 98%. Three antibody tests achieved both thresholds. Evidence for nucleic acid point-of-care tests remains scarce at present, and sensitivity varied substantially. Study heterogeneity was low for eight of 14 sensitivity and 68 of 84 specificity results with confidence interval width ≤ 5%, and lower for nucleic acid tests than antibody tests. Manufacturer-reported clinical performance was significantly higher than independently assessed in 11 of 32 and four of 34 cases, respectively, for sensitivity and specificity, indicating a need for improvement in this area.ConclusionContinuous monitoring of clinical performance within more clearly defined target populations is needed.

Keywords: COVID-19; SARS-CoV-2; accuracy; diagnostic; meta-analysis; sensitivity; specificity.

PubMed Disclaimer

Conflict of interest statement

Conflict of interest: None declared.

Figures

Figure 1
Figure 1
Selection of public studies on clinical performance of SARS-CoV-2 nucleic acid and antibody tests, up to 22 August 2020 (n = 151)
Figure 2
Figure 2
Independently assessed vs manufacturer-reported clinical sensitivity and specificity per SARS-CoV-2 test, up to 22 August 2020 (n = 55)
See this image and copyright information in PMC

Comment in

References

    1. United States Food and Drug Administration (FDA). Emergency use authorizations for medical devices. Silver Spring: FDA. [Accessed: 20 Jul 2020]. Available from: https://www.fda.gov/medical-devices/emergency-situations-medical-devices...
    1. World Health Organisation (WHO). WHO Emergency Use Listing for In vitro diagnostics (IVDs) Detecting SARS-CoV-2. Geneva: WHO. [Accessed: 31 Oct 2021]. Available from: https://www.who.int/publications/m/item/200922-eul-sars-cov2-product-list
    1. Joint Research Centre of the European Commission. COVID-19 in vitro diagnostic devices and test methods database. Brussels: European Commission. [Accessed: 20 Jul 2020]. Available from: https://covid-19-diagnostics.jrc.ec.europa.eu
    1. Foundation for Innovative Diagnostics (FIND). COVID-19 tests (commercialized & in development). Geneva: FIND. [Accessed: 20 Jul 2020]. Available from: https://www.finddx.org/covid-19/tests
    1. United States Food and Drug Administration (FDA). openFDA COVID-19 serological testing evaluations. Silver Spring: FDA. [Accessed: 20 Jul 2020]. Available from: https://open.fda.gov/apis/device/covid19serology/download

Publication types