Journal Article
Variable detection of Omicron-BA.1 and -BA.2 by SARS-CoV-2 rapid antigen tests
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
Medical Microbiology and Immunology · Vol. 212, Issue 1 · pp. 13-23 · 2023
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 × 10 4 to 9.2 × 10 5 RNA copies subjected to the RAT for Omicron-BA.1 compared to 1.3 × 10 5 to 1.5 × 10 6 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.