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Published in: Medical Microbiology and Immunology 1/2023

Open Access 12-11-2022 | SARS-CoV-2 | Original Investigation

Variable detection of Omicron-BA.1 and -BA.2 by SARS-CoV-2 rapid antigen tests

Authors: Andreas Osterman, Irina Badell, Christopher Dächert, Nikolas Schneider, Anna-Yasemin Kaufmann, Gamze Naz Öztan, Melanie Huber, Patricia M. Späth, Marcel Stern, Hanna Autenrieth, Maximilian Muenchhoff, Alexander Graf, Stefan Krebs, Helmut Blum, Ludwig Czibere, Jürgen Durner, Lars Kaderali, Hanna‑Mari Baldauf, Oliver T. Keppler

Published in: Medical Microbiology and Immunology | Issue 1/2023

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Abstract

During 2022, the COVID-19 pandemic has been dominated by the variant of concern (VoC) Omicron (B.1.1.529) and its rapidly emerging subvariants, including Omicron-BA.1 and -BA.2. Rapid antigen tests (RATs) are part of national testing strategies to identify SARS-CoV-2 infections on site in a community setting or to support layman’s diagnostics at home. We and others have recently demonstrated an impaired RAT detection of infections caused by Omicron-BA.1 compared to Delta. Here, we evaluated the performance of five SARS-CoV-2 RATs in a single-centre laboratory study examining a total of 140 SARS-CoV-2 PCR-positive respiratory swab samples, 70 Omicron-BA.1 and 70 Omicron-BA.2, as well as 52 SARS-CoV-2 PCR-negative swabs collected from March 8th until April 10th, 2022. One test did not meet minimal criteria for specificity. In an assessment of the analytical sensitivity in clinical specimen, the 50% limit of detection (LoD50) ranged from 4.2 × 104 to 9.2 × 105 RNA copies subjected to the RAT for Omicron-BA.1 compared to 1.3 × 105 to 1.5 × 106 for Omicron-BA.2. Overall, intra-assay differences for the detection of Omicron-BA.1-containing and Omicron-BA.2-containing samples were non-significant, while a marked overall heterogeneity among the five RATs was observed. To score positive in these point-of-care tests, up to 22-fold (LoD50) or 68-fold (LoD95) higher viral loads were required for the worst performing compared to the best performing RAT. The rates of true-positive test results for these Omicron subvariant-containing samples in the highest viral load category (Ct values < 25) ranged between 44.7 and 91.1%, while they dropped to 8.7 to 22.7% for samples with intermediate Ct values (25–30). In light of recent reports on the emergence of two novel Omicron-BA.2 subvariants, Omicron-BA.2.75 and BJ.1, awareness must be increased for the overall reduced detection rate and marked differences in RAT performance for these Omicron subvariants.
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Metadata
Title
Variable detection of Omicron-BA.1 and -BA.2 by SARS-CoV-2 rapid antigen tests
Authors
Andreas Osterman
Irina Badell
Christopher Dächert
Nikolas Schneider
Anna-Yasemin Kaufmann
Gamze Naz Öztan
Melanie Huber
Patricia M. Späth
Marcel Stern
Hanna Autenrieth
Maximilian Muenchhoff
Alexander Graf
Stefan Krebs
Helmut Blum
Ludwig Czibere
Jürgen Durner
Lars Kaderali
Hanna‑Mari Baldauf
Oliver T. Keppler
Publication date
12-11-2022
Publisher
Springer Berlin Heidelberg
Published in
Medical Microbiology and Immunology / Issue 1/2023
Print ISSN: 0300-8584
Electronic ISSN: 1432-1831
DOI
https://doi.org/10.1007/s00430-022-00752-7

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