In 2020, the World Health Organization (WHO) recommended two SARS-CoV-2 lateral flow antigen-detecting rapid diagnostics tests (Ag-RDTs), both initially with nasopharyngeal (NP) sample collection. Independent head-to-head studies are necessary for SARS-CoV-2 Ag-RDT nasal sampling to demonstrate comparability of performance with nasopharyngeal (NP) sampling. We conducted a head-to-head comparison study of a supervised, self-collected nasal mid-turbinate (NMT) swab and a professional-collected NP swab, using the Panbio™ Ag-RDT (distributed by Abbott). We calculated positive and negative percent agreement between the sampling methods as well as sensitivity and specificity for both sampling techniques compared to the reference standard reverse transcription polymerase chain reaction (RT-PCR). A SARS-CoV-2 infection could be diagnosed by RT-PCR in 45 of 290 participants (15.5%). Comparing the NMT and NP sampling the positive percent agreement of the Ag-RDT was 88.1% (37/42 PCR positives detected; CI 75.0–94.8%). The negative percent agreement was 98.8% (245/248; CI 96.5–99.6%). The overall sensitivity of Panbio with NMT sampling was 84.4% (38/45; CI 71.2–92.3%) and 88.9% (40/45; CI 76.5–95.5%) with NP sampling. Specificity was 99.2% (243/245; CI 97.1–99.8%) for both, NP and NMT sampling. The sensitivity of the Panbio test in participants with high viral load (> 7 log₁₀ SARS-CoV-2 RNA copies/mL) was 96.3% (CI 81.7–99.8%) for both, NMT and NP sampling. For the Panbio supervised NMT self-sampling yields comparable results to NP sampling. This suggests that nasal self-sampling could be used for to enable scaled-up population testing.

Clinical Trial DRKS00021220.

2020 年，世界卫生组织 (WHO) 推荐了两种 SARS-CoV-2 侧流抗原检测快速诊断测试 (Ag-RDT)，最初均采用鼻咽 (NP) 样本采集。对于 SARS-CoV-2 Ag-RDT 鼻腔采样，需要进行独立的头对头研究，以证明其性能与鼻咽 (NP) 采样的可比性。我们使用 Panbio™ Ag-RDT（由 Abbott 分销）对监督下自行采集的中鼻甲 (NMT) 拭子和专业采集的 NP 拭子进行了头对头比较研究。与参考标准逆转录聚合酶链式反应 (RT-PCR) 相比，我们计算了采样方法之间的阳性和阴性百分比一致性，以及两种采样技术的灵敏度和特异性。290 名参与者中有 45 名（15.5%）可以通过 RT-PCR 诊断出 SARS-CoV-2 感染。比较 NMT 和 NP 采样，Ag-RDT 的阳性百分比一致性为 88.1%（检测到 37/42 PCR 阳性；CI 75.0–94.8%）。负一致性百分比为 98.8% (245/248; CI 96.5–99.6%)。Panbio 采用 NMT 采样的总体敏感性为 84.4% (38/45; CI 71.2–92.3%)，采用 NP 采样的总体敏感性为 88.9% (40/45; CI 76.5–95.5%)。NP 和 NMT 采样的特异性均为 99.2% (243/245；CI 97.1–99.8%)。_{Panbio 测试在高病毒载量（> 7 log 10} SARS-CoV-2 RNA 拷贝/mL）参与者中进行的 NMT 和 NP 采样的敏感性均为 96.3% (CI 81.7–99.8%)。对于 Panbio 监督的 NMT 自采样产生的结果与 NP 采样相当。这表明鼻腔自我采样可用于扩大人群测试。

临床试验DRKS00021220。