Osmanodja Bilgin, Budde Klemens, Zickler Daniel, Naik Marcel G, Hofmann Jörg, Gertler Maximilian, Hülso Claudia, Rössig Heike, Horn Philipp, Seybold Joachim, Lunow Stephanie, Bothmann Melanie, Barrera-Pesek Astrid, Mayrdorfer Manuel
Department of Nephrology and Medical Intensive Care, Charité-Universitätsmedizin Berlin, 10117 Berlin, Germany.
Berlin Institute of Health, 10117 Berlin, Germany.
J Clin Med. 2021 May 13;10(10):2099. doi: 10.3390/jcm10102099.
Antigen-detecting rapid diagnostic tests (Ag-RDT) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) offer new opportunities for the quick and laboratory-independent identification of infected individuals for control of the SARS-CoV-2 pandemic. Despite the potential benefits, nasopharyngeal sample collection is frequently perceived as uncomfortable by patients and requires trained healthcare personnel with protective equipment. Therefore, anterior nasal self-sampling is increasingly recognized as a valuable alternative. We performed a prospective, single-center, point of care validation of an Ag-RDT using a polypropylene absorbent collector for standardized self-collected anterior nasal swabs. Real-time polymerase chain reaction (RT-PCR) from combined oropharyngeal/nasopharyngeal swabs served as a comparator. Primary endpoint was sensitivity of the standardized Ag-RDT in symptomatic patients with medium or high viral concentration (≥1 million RNA copies on RT-PCR for SARS-CoV-2). Between 12 February and 22 March 2021, 388 participants were enrolled. After exclusion of 9 patients for which no PCR result could be obtained, the novel Ag-RDT was evaluated based on 379 participants, of whom 273 were symptomatic and 106 asymptomatic. In 61 samples from symptomatic patients with medium or high viral load (≥1 million RNA copies), the sensitivity of the standardized Ag-RDT was 96.7% (59/61; 95% confidence interval (CI): 88.7-99.6%) for the primary endpoint. In total, 62 positive Ag-RDT results were detected out of 70 RT-PCR positive individuals, yielding an overall sensitivity of 88.6% (95% CI: 78.7-94.9%). Specificity was 99.7% (95% CI: 98.2-100%) in 309 RT-PCR negative individuals. Here, we present a validation of a novel Ag-RDT with a standardized sampling process for anterior nasal self-collection, which meets World Health Organisation (WHO) criteria of ≥80% sensitivity and ≥97% specificity. Although less sensitive than RT-PCR, this assay could be beneficial due to its rapid results, ease of use, and suitability for standardized self-testing.
用于严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的抗原检测快速诊断测试（Ag-RDT）为快速且无需实验室检测即可识别感染者以控制SARS-CoV-2大流行提供了新机会。尽管有潜在益处，但患者通常认为采集鼻咽样本不舒服，且需要配备防护设备的经过培训的医护人员。因此，前鼻自我采样越来越被视为一种有价值的替代方法。我们使用聚丙烯吸收性采集器对标准化自我采集的前鼻拭子进行了Ag-RDT的前瞻性、单中心即时检验验证。以联合口咽/鼻咽拭子的实时聚合酶链反应（RT-PCR）作为对照。主要终点是标准化Ag-RDT对病毒浓度中等或高（SARS-CoV-2的RT-PCR检测≥100万个RNA拷贝）的有症状患者的敏感性。在2021年2月12日至3月22日期间，招募了388名参与者。在排除9名无法获得PCR结果的患者后，基于379名参与者对新型Ag-RDT进行了评估，其中273名有症状，106名无症状。在来自病毒载量中等或高（≥100万个RNA拷贝）的有症状患者的61份样本中，标准化Ag-RDT对主要终点的敏感性为96.7%（59/61；95%置信区间（CI）：88.7-99.6%）。在70名RT-PCR阳性个体中，总共检测到62份Ag-RDT阳性结果，总体敏感性为88.6%（95%CI：78.7-94.9%）。在309名RT-PCR阴性个体中，特异性为99.7%（95%CI：98.2-100%）。在此，我们展示了一种具有标准化前鼻自我采集采样过程的新型Ag-RDT的验证，该验证符合世界卫生组织（WHO）灵敏度≥80%和特异性≥97%的标准。尽管该检测不如RT-PCR敏感，但由于其结果快速、使用方便且适合标准化自我检测，可能会有益处。
