Virus variant specific clinical performance of a SARS-CoV-2 rapid antigen test with focus on omicron VOC

Bornemann L, Kaup O, Kleideiter J, Ruprecht B, Hoyer A, Panning M, Bornemann R, Wehmeier M (2023)
Clinical Microbiology and Infection.

Zeitschriftenaufsatz | E-Veröff. vor dem Druck | Englisch
 
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Autor*in
Bornemann, Linus; Kaup, OlafUniBi ; Kleideiter, Johannes; Ruprecht, BertramUniBi; Hoyer, AnnikaUniBi ; Panning, Marcus; Bornemann, ReinhardUniBi; Wehmeier, Michael
Abstract / Bemerkung
OBJECTIVES: Antigen rapid diagnostic tests (Ag-RDTs) play an important role in the diagnosis of SARS-CoV-2. They are easier, quicker, and less expensive than the "gold standard" RT-PCR and therefore widely in use. Reliable clinical data with respect to Ag-RDT performance in SARS-CoV-2 Omicron VOCs is limited. Consequently, the objective of this study was to determine the impact different VOCs - especially Omicron - have on the clinical performance of an Ag-RDT.; METHODS: We compared the clinical performance of the Sofia SARS-CoV-2 Ag-RDT to RT-PCR in a real-world, single-centre study in a clinical point-of-care setting in patients admitted to a large hospital via the emergency department from 2 November 2020 to 4 September 2022.; RESULTS: Among 38,434 Ag-RDT/RT-PCR tandems taken, 1528 yielded a SARS-CoV-2 positive RT-PCR test result, with a prevalence of 4.0% (95% CI, 3.8 - 4.2). Overall sensitivity of the Ag-RDT was 63.7% (95% CI, 61.3 - 66.1) and overall specificity was 99.6% (95% CI, 99.5 - 99.6). Ag-RDT sensitivity was dependent on viral load (VL), as the sensitivity increased to 93.2% (95% CI, 91.5 - 94.6) in samples with a VL >106 SARS-CoV-2 copies/ml. Furthermore, the Ag-RDT was more sensitive in men, and older patients. Variant-dependent sensitivity assessment showed that the sensitivity was significantly lower in Omicron-VOC (64.1%; 95% CI, 60.5 - 67.6) compared to SARS-CoV-2 Wild-type samples (70.0%; 95% CI, 59,8 - 78,6) (binomial test; p-value <0.001). Analyzing the limits of detection (LoD) showed a 27 times higher 95% LoD for the Omicron-VOC BA.5 compared to the SARS-CoV-2 Wild-type.; CONCLUSION: Ag-RDT sensitivity for detection of patients with lower viral loads and with Omicron-VOC is reduced, limiting the effectiveness of Ag-RDTs. However, Ag-RDTs are still an unreplaceable tool for widely available, quick, and inexpensive point-of-care SARS-CoV-2 diagnostics. Copyright © 2023. Published by Elsevier Ltd.
Erscheinungsjahr
2023
Zeitschriftentitel
Clinical Microbiology and Infection
eISSN
1469-0691
Page URI
https://pub.uni-bielefeld.de/record/2979526

Zitieren

Bornemann L, Kaup O, Kleideiter J, et al. Virus variant specific clinical performance of a SARS-CoV-2 rapid antigen test with focus on omicron VOC. Clinical Microbiology and Infection. 2023.
Bornemann, L., Kaup, O., Kleideiter, J., Ruprecht, B., Hoyer, A., Panning, M., Bornemann, R., et al. (2023). Virus variant specific clinical performance of a SARS-CoV-2 rapid antigen test with focus on omicron VOC. Clinical Microbiology and Infection. https://doi.org/10.1016/j.cmi.2023.05.009
Bornemann, Linus, Kaup, Olaf, Kleideiter, Johannes, Ruprecht, Bertram, Hoyer, Annika, Panning, Marcus, Bornemann, Reinhard, and Wehmeier, Michael. 2023. “Virus variant specific clinical performance of a SARS-CoV-2 rapid antigen test with focus on omicron VOC”. Clinical Microbiology and Infection.
Bornemann, L., Kaup, O., Kleideiter, J., Ruprecht, B., Hoyer, A., Panning, M., Bornemann, R., and Wehmeier, M. (2023). Virus variant specific clinical performance of a SARS-CoV-2 rapid antigen test with focus on omicron VOC. Clinical Microbiology and Infection.
Bornemann, L., et al., 2023. Virus variant specific clinical performance of a SARS-CoV-2 rapid antigen test with focus on omicron VOC. Clinical Microbiology and Infection.
L. Bornemann, et al., “Virus variant specific clinical performance of a SARS-CoV-2 rapid antigen test with focus on omicron VOC”, Clinical Microbiology and Infection, 2023.
Bornemann, L., Kaup, O., Kleideiter, J., Ruprecht, B., Hoyer, A., Panning, M., Bornemann, R., Wehmeier, M.: Virus variant specific clinical performance of a SARS-CoV-2 rapid antigen test with focus on omicron VOC. Clinical Microbiology and Infection. (2023).
Bornemann, Linus, Kaup, Olaf, Kleideiter, Johannes, Ruprecht, Bertram, Hoyer, Annika, Panning, Marcus, Bornemann, Reinhard, and Wehmeier, Michael. “Virus variant specific clinical performance of a SARS-CoV-2 rapid antigen test with focus on omicron VOC”. Clinical Microbiology and Infection (2023).
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