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 Aug 8;33(2):94-104.
eCollection 2022 Aug.

Systematic Review of Diagnostic Accuracy of DiaSorin Liaison SARS-CoV-2 Antigen Immunoassay

Giuseppe Lippi  1   2 , Brandon M Henry  1   3   4 , Mario Plebani  5 , Khosrow Adeli  1   6
Affiliations
Review

Systematic Review of Diagnostic Accuracy of DiaSorin Liaison SARS-CoV-2 Antigen Immunoassay

Giuseppe Lippi et al. EJIFCC. .

Abstract

Background: Quantification of SARS-CoV-2 antigens by means of rapid, high-throughput and fully-automated techniques has been proposed as a feasible alternative to overcome the current shortage of resources for routine molecular diagnostics. To this end, we provide here a systematic review of diagnostic accuracy of DiaSorin Liaison SARS-CoV-2 antigen immunoassay.

Methods: An electronic search was conduced in Medline and Scopus, with no language or date restrictions (up to January 20, 2022), for identifying all published studies articles in which the diagnostic performance of the DiaSorin Liaison SARS-CoV-2 antigen immunoassay was compared with molecular diagnostic techniques.

Results: The electronic search identified a final number of 11 studies, totalling 4449 oro- and naso-pharyngeal specimens. The pooled diagnostic sensitivity, specificity and area under the curve (AUC) of the Liaison SARS-CoV-2 antigen immunoassay in all samples were 0.51 (95%CI, 0.49-0.54), 1.00 (95%CI, 1.00-1.00) and 0.994 (95%CI, 0.990-0.998), respectively, whilst the overall concordance with molecular diagnostics was 82.1%. The pooled diagnostic sensitivity, specificity and AUC of the Liaison SARS-CoV-2 antigen immunoassay in specimens with high viral load (i.e., cycle threshold values <25-30) were 0.79 (95%CI, 0.75-0.82), 1.00 (95%CI, 0.99-1.00) and 0.911 (95%CI, 0.879-0.943), respectively, whilst the overall concordance with molecular diagnostics in such samples increased to 94.2%.

Conclusion: The results of this systematic literature review suggest that there is sufficient accuracy of the DiaSorin Liaison SARS-CoV-2 antigen immunoassay in samples with high viral loads that would enable its reliable usage for identifying superspreaders, who are responsible for the vast majority of transmission events.

Keywords: COVID-19; SARS-CoV-2; antigen; diagnosis; immunoassay.

PubMed Disclaimer

Conflict of interest statement

None

Figures

Figure 1
Figure 1
Cumulative diagnostic sensitivity, specificity and accuracy (Summary Receiver Operating Characteristic Curve; SROC) with 95% confidence interval (95%CI) of the fully automated DiaSorin Liaison SARS-CoV-2 Antigen Immunoassay for diagnosing SARS-CoV-2 infection in nasopharyngeal samples
Figure 2
Figure 2
Diagnostic sensitivity of the fully automated DiaSorin Liaison SARS-CoV-2 Antigen Immunoassay for diagnosing SARS-CoV-2 infection in nasopharyngeal samples with high viral load (i.e., cycle threshold values <25-30). The three lines represent the mean AUC and its 95% confidence interval.
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. Sampath S, Khedr A, Qamar S, Tekin A, Singh R, Green R, Kashyap R. Pandemics Throughout the History. Cureus 2021;13:el8136. - PMC - PubMed
    1. Lippi G, Mattiuzzi C, Henry BM. Updated picture of SARS-CoV-2 variants and mutations. Diagnosis (Berl) 2021;9: 11-17. - PubMed
    1. John Hopkins University. Coronavirus Resource Center. https://coronavirus.jhu.edu/map.html. Last accessed, July 27, 2022.
    1. American Association of Clinical Chemistry. Coronavirus Testing Survey. Available at: https://www.aacc.org/science-and-research/covid-19-resources/aacc-covid-.... Last accessed: January 20, 2022.
    1. Illingworth CJ, Hamilton WL, Warne B, Routledge M, Popay A, Jackson C, et al. . Superspreaders drive the largest outbreaks of hospital onset COVID-19 infections. Elite 2021; 10:e67308. - PMC - PubMed

LinkOut - more resources