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Abstract

Background

Reliable testing for SARS-CoV-2 is key for the management of the COVID-19 pandemic.

Aim

We estimate diagnostic accuracy for nucleic acid and antibody tests 5 months into the COVID-19 pandemic, and compare with manufacturer-reported accuracy.

Methods

We 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).

Results

Pooling 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.

Conclusion

Continuous monitoring of clinical performance within more clearly defined target populations is needed.

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This work is licensed under a Creative Commons Attribution 4.0 International License.
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2021-11-11
2024-12-20
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Meta-analysis of the clinical performance of commercial SARS-CoV-2 nucleic acid and antibody tests up to 22 August 2020
<p class="citation"> <span>Citation style for this article:</span> <span class="meta-value authors"> <a href="/search?value1=Ivo+Van+Walle&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Van Walle Ivo</a>, <a href="/search?value1=Katrin+Leitmeyer&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Leitmeyer Katrin</a>, <a href="/search?value1=Eeva+K+Broberg&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Broberg Eeva K</a>, <a href="/search?value1=the+European+COVID-19+microbiological+laboratories+group&option1=author&noRedirect=true" class="nonDisambigAuthorLink">the European COVID-19 microbiological laboratories group</a></span>. Meta-analysis of the clinical performance of commercial SARS-CoV-2 nucleic acid and antibody tests up to 22 August 2020. <a href="/content/ecdc">Euro Surveill.</a> 2021;26(45):pii=2001675. <a href="https://doi.org/10.2807/1560-7917.ES.2021.26.45.2001675" title="doi link" target="_blank">https://doi.org/10.2807/1560-7917.ES.2021.26.45.2001675</a> <span class="ES_Article_citation"> <span class="generated">Received</span>: 12 Sept 2020;&nbsp;&nbsp; <span class="generated">Accepted</span>: 16 Aug 2021 </span> </p>
/content/10.2807/1560-7917.ES.2021.26.45.2001675
/content/10.2807/1560-7917.ES.2021.26.45.2001675
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