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Abstract

Background

Analyses of diagnostic performance of SARS-CoV-2 antigen rapid diagnostic tests (AG-RDTs) based on long-term data, population subgroups and many AG-RDT types are scarce.

Aim

We aimed to analyse sensitivity and specificity of AG-RDTs for subgroups based on age, incidence, sample type, reason for test, symptoms, vaccination status and the AG-RDT’s presence on approved lists.

Methods

We included AG-RDT results registered in Czechia’s Information System for Infectious Diseases between August and November 2021. Subpopulations were analysed based on 346,000 test results for which a confirmatory PCR test was recorded ≤ 3 days after the AG-RDT; 38 AG-RDTs with more than 100 PCR-positive and 300 PCR-negative samples were individually evaluated.

Results

Average sensitivity and specificity were 72.4% and 96.7%, respectively. We recorded lower sensitivity for age groups 0–12 (65.5%) and 13–18 years (65.3%). The sensitivity level rose with increasing SARS-CoV-2 incidence from 66.0% to 76.7%. Nasopharyngeal samples had the highest sensitivity and saliva the lowest. Sensitivity for preventive reasons was 63.6% vs 86.1% when testing for suspected infection. Sensitivity was 84.8% when one or more symptoms were reported compared with 57.1% for no symptoms. Vaccination was associated with a 4.2% higher sensitivity. Significantly higher sensitivity levels pertained to AG-RDTs on the World Health Organization Emergency Use List (WHO EUL), European Union Common List and the list of the United Kingdom’s Department of Health and Social Care.

Conclusion

AG-RDTs from approved lists should be considered, especially in situations associated with lower viral load. Results are limited to SARS-CoV-2 delta variant.

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2022-08-18
2024-04-23
http://instance.metastore.ingenta.com/content/10.2807/1560-7917.ES.2022.27.33.2200070
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Role of population and test characteristics in antigen-based SARS-CoV-2 diagnosis, Czechia, August to November 2021
<p class="citation"> <span>Citation style for this article:</span> <span class="meta-value authors"> <a href="/search?value1=Tom%C3%A1%C5%A1+Kliegr&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Kliegr Tomáš</a>, <a href="/search?value1=Ji%C5%99%C3%AD+Jarkovsk%C3%BD&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Jarkovský Jiří</a>, <a href="/search?value1=Helena+Ji%C5%99incov%C3%A1&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Jiřincová Helena</a>, <a href="/search?value1=Jaroslav+Kucha%C5%99&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Kuchař Jaroslav</a>, <a href="/search?value1=Tom%C3%A1%C5%A1+Karel&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Karel Tomáš</a>, <a href="/search?value1=Ruth+Tachezy&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Tachezy Ruth</a></span>. Role of population and test characteristics in antigen-based SARS-CoV-2 diagnosis, Czechia, August to November 2021. <a href="/content/ecdc">Euro Surveill.</a> 2022;27(33):pii=2200070. <a href="https://doi.org/10.2807/1560-7917.ES.2022.27.33.2200070" title="doi link" target="_blank">https://doi.org/10.2807/1560-7917.ES.2022.27.33.2200070</a> <span class="ES_Article_citation"> <span class="generated">Received</span>: 19 Jan 2022;&nbsp;&nbsp; <span class="generated">Accepted</span>: 05 Jul 2022 </span> </p>
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