Evaluation of a novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples
Evaluation of a novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples
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DOI：
10.1016/j.ijid.2020.05.098
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发表时间：
2020-10-01
影响因子：
8.4
通讯作者：
Weitzel, Thomas
中科院分区：
文献类型：
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作者：
Porte, Lorena;Legarraga, Paulette;Weitzel, Thomas
目的：在2019冠状病毒病（COVID-19）大流行的背景下，开发和验证快速、简便的诊断方法是当务之急。本研究旨在评估呼吸道样本中检测严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）的新型快速抗原检测方法（RDT）。方法：采用通用输运介质对疑似病例鼻咽拭子和口咽拭子进行SARS-CoV-2抗原荧光免疫层析检测（中国深圳百易生物技术有限公司）。与SARS-CoV-2实时(RT)-PCR进行比较，确定诊断准确性。结果：共纳入样本127份；82例rt - pcr阳性。患者中位年龄为38岁，53.5%为男性，93.7%为症状出现后第一周的患者。总敏感性和特异性分别为93.9%（95%置信区间86.5-97.4%）和100%(95%置信区间92.1-100%)，诊断准确率为96.1%，Kappa系数为0.9。在病毒载量高的样品中，灵敏度明显更高。结论：尽管使用了未经验证的样品材料，但本研究中评估的RDT在主要在症状第一周获得的高病毒载量样本中显示出高灵敏度和特异性。该检测方法有可能成为早期诊断SARS-CoV-2的重要工具，特别是在分子方法有限的情况下。(C) 2020作者。由爱思唯尔有限公司代表国际传染病学会出版。
Objectives: In the context of the coronavirus disease 2019 (COVID-19) pandemic, the development and validation of rapid and easy-to-perform diagnostic methods are of high priority. This study was performed to evaluate a novel rapid antigen detection test (RDT) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in respiratory samples.Methods: The fluorescence immunochromatographic SARS-CoV-2 antigen test (Bioeasy Biotechnology Co., Shenzhen, China) was evaluated using universal transport medium with nasopharyngeal (NP) and oropharyngeal (OP) swabs from suspected COVID-19 cases. Diagnostic accuracy was determined in comparison to SARS-CoV-2 real-time (RT)-PCR.Results: A total of 127 samples were included; 82 were RT-PCR-positive. The median patient age was 38 years, 53.5% were male, and 93.7% were from the first week after symptom onset. Overall sensitivity and specificity were 93.9% (95% confidence interval 86.5-97.4%) and 100% (95% confidence interval 92.1-100%), respectively, with a diagnostic accuracy of 96.1% and Kappa coefficient of 0.9. Sensitivity was significantly higher in samples with high viral loads.Conclusions: The RDT evaluated in this study showed a high sensitivity and specificity in samples mainly obtained during the first week of symptoms and with high viral loads, despite the use of a non-validated sample material. The assay has the potential to become an important tool for early diagnosis of SARS-CoV-2, particularly in situations with limited access to molecular methods. (C) 2020 The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases.