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. 2023 Feb;51(1):239-245.
doi: 10.1007/s15010-022-01844-5. Epub 2022 May 20.

Analysis of seven SARS-CoV-2 rapid antigen tests in detecting omicron (B.1.1.529) versus delta (B.1.617.2) using cell culture supernatants and clinical specimens

Sabrina Jungnick #  1 , Bernhard Hobmaier #  1 , Natali Paravinja #  1 , Lena Mautner  2 , Mona Hoyos  2 , Regina Konrad  1 , Maren Haase  2 , Armin Baiker  2 , Ute Eberle  1 , Magdalena Bichler  1 , Bianca Treis  1 , Mercy Okeyo  1 , Barbara Streibl  1 , Clara Wimmer  1 , Sabrina Hepner  1 , Annika Sprenger  1 , Carola Berger  1 , Laura Weise  1 , Alexandra Dangel  1 , Siegfried Ippisch  3 , Walter Jonas  4 , Manfred Wildner  5   4 , Bernhard Liebl  5   4 , Nikolaus Ackermann  1 , Andreas Sing  1   5 , Volker Fingerle  6 ; Bavarian SARS-CoV-2-Public Health Laboratory Team
Collaborators, Affiliations

Analysis of seven SARS-CoV-2 rapid antigen tests in detecting omicron (B.1.1.529) versus delta (B.1.617.2) using cell culture supernatants and clinical specimens

Sabrina Jungnick et al. Infection. 2023 Feb.

Abstract

Purpose: Omicron is rapidly spreading as a new SARS-CoV-2 variant of concern (VOC). The question whether this new variant has an impact on SARS-CoV-2 rapid antigen test (RAT) performance is of utmost importance. To obtain an initial estimate regarding differences of RATs in detecting omicron and delta, seven commonly used SARS-CoV-2 RATs from different manufacturers were analysed using cell culture supernatants and clinical specimens.

Methods: For this purpose, cell culture-expanded omicron and delta preparations were serially diluted in Dulbecco's modified Eagle's Medium (DMEM) and the Limit of Detection (LoD) for both VOCs was determined. Additionally, clinical specimens stored in viral transport media or saline (n = 51) were investigated to complement in vitro results with cell culture supernatants. Ct values and RNA concentrations were determined via quantitative reverse transcription polymerase chain reaction (RT-qPCR).

Results: The in vitro determination of the LoD showed no obvious differences in detection of omicron and delta for the RATs examined. The LoD in this study was at a dilution level of 1:1,000 (corresponding to 3.0-5.6 × 106 RNA copies/mL) for tests I-V and at a dilution level of 1:100 (corresponding to 3.7-4.9 × 107 RNA copies/mL) for tests VI and VII. Based on clinical specimens, no obvious differences were observed between RAT positivity rates when comparing omicron to delta in this study setting. Overall positivity rates varied between manufacturers with 30-81% for omicron and 42-71% for delta. Test VII was only conducted in vitro with cell culture supernatants for feasibility reasons. In the range of Ct < 23, positivity rates were 50-100% for omicron and 67-93% for delta.

Conclusion: In this study, RATs from various manufacturers were investigated, which displayed no obvious differences in terms of analytical LoD in vitro and RAT positivity rates based on clinical samples comparing the VOCs omicron and delta. However, differences between tests produced by various manufacturers were detected. In terms of clinical samples, a focus of this study was on specimens with high virus concentrations. Further systematic, clinical and laboratory studies utilizing large datasets are urgently needed to confirm reliable performance in terms of sensitivity and specificity for all individual RATs and SARS-CoV-2 variants.

Keywords: Comparison; Delta (B.1.617.2); Omicron (B.1.1.529); SARS-CoV-2 rapid antigen test; Variants of concern.

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Conflict of interest statement

On behalf of all the authors, the corresponding author states that there is no conflict of interest.

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References

    1. World Health Organization. Classification of Omicron (B.1.1.529): SARS-CoV-2 Variant of Concern. 2021. https://www.who.int/news/item/26-11-2021-classification-of-omicron-(b.1.... Accessed 20 Jan 2022.
    1. Viana R, Moyo S, Amoako DG, Tegally H, Scheepers C, Althaus CL, et al. Rapid epidemic expansion of the SARS-CoV-2 Omicron variant in southern Africa. Nature. 2022 doi: 10.1038/d41586-021-03832-5. - DOI - PMC - PubMed
    1. Latif AA, Mullen JL, Alkuzweny M, Tsueng G, Cano M, Haag E, et al. B.1.1.529 Lineage Report. outbreak.info. 2022. https://outbreak.info/situation-reports?pango=B.1.1.529 Accessed 20 Jan 2022.
    1. Ferré VM, Peiffer-Smadja N, Visseaux B, Descamps D, Ghosn J, Charpentier C. Omicron SARS-CoV-2 variant: What we know and what we don't. Anaesthesia Crit Care Pain Med. 2021;41(1):100998–100998. doi: 10.1016/j.accpm.2021.100998. - DOI - PMC - PubMed
    1. Scheiblauer H, Filomena A, Nitsche A, Puyskens A, Corman VM, Drosten C, et al. Comparative sensitivity evaluation for 122 CE-marked rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021. Eurosurveillance. 2021; 26(44). 10.2807/1560-7917.es.2021.26.44.2100441 - PMC - PubMed

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