Details

Autor(en) / Beteiligte

• Krenn, Franziska
• Dächert, Christopher
• Badell, Irina
• Lupoli, Gaia
• Öztan, Gamze Naz
• Feng, Tianle
• Schneider, Nikolas
• Huber, Melanie
• Both, Hanna
• Späth, Patricia M.
• Muenchhoff, Maximilian
• Graf, Alexander
• Krebs, Stefan
• Blum, Helmut
• Durner, Jürgen
• Czibere, Ludwig
• Kaderali, Lars
• Keppler, Oliver T.
• Baldauf, Hanna-Mari
• Osterman, Andreas

Titel

Ten rapid antigen tests for SARS-CoV-2 widely differ in their ability to detect Omicron-BA.4 and -BA.5

Ist Teil von

• Medical microbiology and immunology, 2023-10, Vol.212 (5), p.323-337

Ort / Verlag

Berlin/Heidelberg: Springer Berlin Heidelberg

Erscheinungsjahr

2023

Link zum Volltext

Quelle

Springer journals

Beschreibungen/Notizen

• Since late 2021, the variant landscape of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been dominated by the variant of concern (VoC) Omicron and its sublineages. We and others have shown that the detection of Omicron-BA.1 and -BA.2-positive respiratory specimens by rapid antigen tests (RATs) is impaired compared to Delta VoC-containing samples. Here, in a single-center retrospective laboratory study, we evaluated the performance of ten most commonly used RATs for the detection of Omicron-BA.4 and -BA.5 infections. We used 171 respiratory swab specimens from SARS-CoV-2 RNA-positive patients, of which 71 were classified as BA.4 and 100 as BA.5. All swabs were collected between July and September 2022. 50 SARS-CoV-2 PCR-negative samples from healthy individuals, collected in October 2022, showed high specificity in 9 out of 10 RATs. When assessing analytical sensitivity using clinical specimens, the 50% limit of detection (LoD50) ranged from 7.6 × 10 4 to 3.3 × 10 6 RNA copies subjected to the RATs for BA.4 compared to 6.8 × 10 4 to 3.0 × 10 6 for BA.5. Overall, intra-assay differences for the detection of these two Omicron subvariants were not significant for both respiratory swabs and tissue culture-expanded virus isolates. In contrast, marked heterogeneity was observed among the ten RATs: to be positive in these point-of-care tests, up to 443-fold (BA.4) and up to 56-fold (BA.5) higher viral loads were required for the worst performing RAT compared to the best performing RAT. True-positive rates for Omicron-BA.4- or -BA.5-containing specimens in the highest viral load category ( C t values < 25) ranged from 94.3 to 34.3%, dropping to 25.6 to 0% for samples with intermediate C t values (25–30). We conclude that the high heterogeneity in the performance of commonly used RATs remains a challenge for the general public to obtain reliable results in the evolving Omicron subvariant-driven pandemic.