Panbio antigen rapid test is reliable to diagnose SARS-CoV-2 infection in the first 7 days after the onset of symptoms.
Panbio antigen rapid test is reliable to diagnose SARS-CoV-2 infection in the first 7 days after the onset of symptoms.
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DOI：
10.1016/j.jcv.2020.104659
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发表时间：
2020-12
期刊：
影响因子：
--
通讯作者：
Cuadros J
中科院分区：
文献类型：
--
作者：
Linares M;Pérez-Tanoira R;Carrero A;Romanyk J;Pérez-García F;Gómez-Herruz P;Arroyo T;Cuadros J
新的抗原检测因其足够的敏感性和特异性而成为控制这一流行病不可或缺的工具。在初级保健中实施床旁技术是可行的，效果良好。抗原技术的结果由症状发作少于5天和PCR中CT低于27来确定。RT-qPCR是目前推荐的诊断SARS-CoV-2急性感染的实验室方法，但由于需要特殊设备、耗时、成本高和技术人员等因素限制了其应用。更快速和高通量的方法是必不可少的。我们分析了2020年9月期间从马德里一家二级医院急诊科和两个初级医疗保健中心就诊的患者中收集的临床数据和鼻咽样本。将Panbio™ COVID-19 AG快速检测装置检测SARS-CoV-2抗原的性能与RT-qPCR进行了比较。对255份鼻咽拭子进行了检测，其中150份来自急诊科，105份来自初级救助中心。184例患者有症状（72.1%）。在60份阳性RT-qPCR样本中，40份通过快速抗原检测检出，总体灵敏度为73.3%。所有用快速抗原检测法检测为阳性的样品用RT-qPCR也为阳性。中位周期阈值为23.28（IQR 18.5-30.16）。症状发作少于7天的患者表现出更高的病毒载量和快速抗原检测的敏感性（86.5%），与症状发作天数更多的患者相比（敏感性为53.8%）（p < 0.004）。本研究中评价的快速抗原检测在症状第一周和高病毒载量期间获得的样本中显示出高灵敏度和特异性。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。
The new antigen test is an indispensable tool in the control of the pandemic due to its adequate sensitivity and specificity. The implementation of the point of care technique in primary care is feasible and has good results. Results of the antigen techniques are determined by an onset of symptoms inferior to five days and a CT below 27 in PCR. 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.
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