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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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/content/10.2807/1560-7917.ES.2023.28.38.2200938
2023-09-21
2024-06-20
http://instance.metastore.ingenta.com/content/10.2807/1560-7917.ES.2023.28.38.2200938
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