Departamento de Microbiología Clínica, Hospital Universitario Príncipe de Asturias, Madrid, Spain.
Departamento de Microbiología Clínica, Hospital Universitario Príncipe de Asturias, Madrid, Spain; Departamento de Biomedicina y Biotecnología, Facultad de Medicina, Universidad de Alcalá de Henares, Spain.
J Clin Virol. 2020 Dec;133:104659. doi: 10.1016/j.jcv.2020.104659. Epub 2020 Oct 16.
RT-qPCR is the current recommended laboratory method to diagnose SARS-CoV-2 acute infection, several factors such as requirement of special equipment, time consuming, high cost and skilled staff limit the use of these techniques. A more rapid and high-throughput method is essential.
We analyzed clinical data and nasopharyngeal samples, collected during September 2020, from patients attended at the emergency department of a secondary hospital and in two primary healthcare centers in Madrid. The performance of the Panbio™ COVID-19 AG Rapid Test Device for the detection of SARS-CoV-2 antigen was compared to RT-qPCR.
255 nasopharyngeal swabs, including 150 from the emergency department and 105 from primary helthcare centers, were tested. 184 patients were symptomatic (72.1 %). Amongst the 60 positive RT-qPCR samples, 40 were detected by the rapid antigen test, given an overall sensitivity of 73.3 %. All the samples detected positive with the rapid antigen test were also positive with RT-qPCR. The median cycle threshold was 23.28 (IQR 18.5-30.16). Patients with less than seven days onset of symptoms showed a higher viral load, and sensitivity for rapid antigen test (86.5 %), compared to those with more days (sensitivity of 53.8 %)(p < 0.004).
The rapid antigen test evaluated in this study showed a high sensitivity and specificity in samples obtained during the first week of symptoms and with high viral loads. This assay seems to be an effective strategy for controlling the COVID-19 pandemic for the rapid identification and isolation of SARS-CoV-2 infected patients.
实时荧光定量 RT-PCR 是目前推荐用于诊断 SARS-CoV-2 急性感染的实验室方法，但是该方法需要特殊设备、耗时、成本高且需要专业人员，限制了其应用。因此，需要一种更快速、高通量的方法。
我们分析了 2020 年 9 月在马德里一家二级医院的急诊科和两家初级保健中心采集的临床数据和鼻咽样本。比较了 Panbio™ COVID-19 AG 快速检测设备检测 SARS-CoV-2 抗原的性能与 RT-qPCR。
共检测了 255 个鼻咽拭子，其中 150 个来自急诊科，105 个来自初级保健中心，184 例患者有症状（72.1%）。在 60 个 RT-qPCR 阳性样本中，有 40 个被快速抗原检测法检测到，总体敏感性为 73.3%。所有用快速抗原检测法检测为阳性的样本均与 RT-qPCR 结果一致。中位循环阈值为 23.28（IQR 18.5-30.16）。症状发作少于 7 天的患者病毒载量更高，且快速抗原检测法的敏感性更高（86.5%），而症状发作超过 7 天的患者敏感性较低（53.8%）（p<0.004）。
在本研究中评估的快速抗原检测法在症状发作的第一周内获得的样本中具有较高的敏感性和特异性，且病毒载量较高。该检测方法似乎是控制 COVID-19 大流行的有效策略，可快速识别和隔离 SARS-CoV-2 感染患者。
