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Abstract

Background

The sensitivity and specificity of selected antigen detection rapid diagnostic tests (AG-RDTs) for SARS-CoV-2 were determined in the unvaccinated population when the Delta variant was circulating. Viral loads, dynamics, symptoms and tissue tropism differ between Omicron and Delta.

Aim

We aimed to compare AG-RDT sensitivity and specificity in selected subgroups during Omicron vs Delta circulation.

Methods

We retrospectively paired AG-RDT results with PCRs registered in Czechia’s Information System for Infectious Diseases from 1 to 25 December 2021 (Delta, n = 20,121) and 20 January to 24 February 2022 (Omicron, n = 47,104).

Results

When confirmatory PCR was conducted on the same day as AG-RDT as a proxy for antigen testing close to peak viral load, the average sensitivity for Delta was 80.4% and for Omicron 81.4% (p < 0.05). Sensitivity in vaccinated individuals was lower for Omicron (OR = 0.94; 95% confidence interval (CI): 0.87–1.03), particularly in reinfections (OR = 0.83; 95% CI: 0.75–0.92). Saliva AG-RDT sensitivity was below average for both Delta (74.4%) and Omicron (78.4%). Tests on the European Union Category A list had higher sensitivity than tests in Category B. The highest sensitivity for Omicron (88.5%) was recorded for patients with loss of smell or taste, however, these symptoms were almost 10-fold less common than for Delta. The sensitivity of AG-RDTs performed on initially asymptomatic individuals done 1, 2 or 3 days before a positive PCR test was consistently lower for Omicron compared with Delta.

Conclusion

Sensitivity for Omicron was lower in subgroups that may become more common if SARS-CoV-2 becomes an endemic virus.

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This work is licensed under a Creative Commons Attribution 4.0 International License.
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2023-09-21
2024-12-27
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Can variants, reinfection, symptoms and test types affect COVID-19 diagnostic performance? A large-scale retrospective study of AG-RDTs during circulation of Delta and Omicron variants, Czechia, December 2021 to February 2022
<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=David+Chud%C3%A1n&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Chudán David</a>, <a href="/search?value1=Stanislav+Voj%C3%AD%C5%99&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Vojíř Stanislav</a>, <a href="/search?value1=Michal+Zav%C5%99el&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Zavřel Michal</a>, <a href="/search?value1=Ond%C5%99ej+%C5%A0anca&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Šanca Ondřej</a>, <a href="/search?value1=Ruth+Tachezy&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Tachezy Ruth</a></span>. Can variants, reinfection, symptoms and test types affect COVID-19 diagnostic performance? A large-scale retrospective study of AG-RDTs during circulation of Delta and Omicron variants, Czechia, December 2021 to February 2022. <a href="/content/ecdc">Euro Surveill.</a> 2023;28(38):pii=2200938. <a href="https://doi.org/10.2807/1560-7917.ES.2023.28.38.2200938" title="doi link" target="_blank">https://doi.org/10.2807/1560-7917.ES.2023.28.38.2200938</a> <span class="ES_Article_citation"> <span class="generated">Received</span>: 09 Dec 2022;&nbsp;&nbsp; <span class="generated">Accepted</span>: 26 May 2023 </span> </p>
/content/10.2807/1560-7917.ES.2023.28.38.2200938
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