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.

2022 年期间，COVID-19 大流行主要由关注变体 (VoC) Omicron (B.1.1.529) 及其快速出现的亚变体（包括 Omicron-BA.1 和 -BA.2）主导。快速抗原检测 (RAT) 是国家检测策略的一部分，用于在社区环境中现场识别 SARS-CoV-2 感染或支持外行在家中进行诊断。我们和其他人最近证明，与 Delta 相比，RAT 对 Omicron-BA.1 引起的感染的检测能力较差。在这里，我们在一项单中心实验室研究中评估了 5 种 SARS-CoV-2 RAT 的性能，该研究检查了总共 140 个 SARS-CoV-2 PCR 阳性呼吸道拭子样本，其中 70 个 Omicron-BA.1 和 70 个 Omicron-BA。 2 以及 2022 年 3 月 8 日至 4 月 10 日期间收集的 52 个 SARS-CoV-2 PCR 阴性拭子。其中一项测试未达到最低特异性标准。在评估临床样本的分析灵敏度时，Omicron-BA.1 的 50% 检测限 (LoD50) 范围为 4.2 × 10 ⁴至 9.2 × 10 ⁵ RNA 拷贝，而 RAT 为 1.3 × 10 5 至 1.3 × 10 ⁵。Omicron-BA.2 为1.5 × 10 ^{6 。}总体而言，含有 Omicron-BA.1 和 Omicron-BA.2 的样品的检测内差异不显着，而五种 RAT 之间观察到明显的总体异质性。为了在这些即时检测中获得阳性结果，与表现最好的 RAT 相比，表现最差的 RAT 需要高出 22 倍 (LoD50) 或 68 倍 (LoD95) 的病毒载量。这些含有 Omicron 亚变体的样本在最高病毒载量类别（Ct 值 < 25）中的真阳性检测结果率在 44.7% 至 91.1% 之间，而对于具有中间 Ct 值（25 –30）。鉴于最近有关两种新型 Omicron-BA.2 亚变体 Omicron-BA.2.75 和 BJ.1 出现的报道，必须提高对这些 Omicron 亚变体整体检测率降低和 RAT 性能显着差异的认识。