Four point-of-care lateral flow immunoassays for diagnosis of COVID-19 and for assessing dynamics of antibody responses to SARS-CoV-2
Four point-of-care lateral flow immunoassays for diagnosis of COVID-19 and for assessing dynamics of antibody responses to SARS-CoV-2
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DOI：
10.1016/j.jinf.2020.06.023
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发表时间：
2020-09-01
影响因子：
28.2
通讯作者：
Chen, Shyr-Chyr
中科院分区：
文献类型：
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作者：
Wu, Jhong-Lin;Tseng, Wen-Pin;Chen, Shyr-Chyr
目的：我们旨在评估快速血清学检测在 2019 年冠状病毒病 (COVID-19) 患者管理中的作用。方法：这项回顾性研究在 3 个月的时间里，在台湾一家医疗中心招募了 16 名实时逆转录聚合酶链反应确诊的有症状的 COVID-19 患者和 58 名 COVID-19 阴性患者。收集连续血清样本，并使用四种即时检测 (POC) 侧流免疫分析 (LFIA)（ALLTEST 2019-nCoV IgG/IgM 快速检测、Dynamiker 2019-nCoV IgG/IgM 快速检测、ASK COVID-19 IgG/IgM 快速检测和 Wondfo SARS-CoV-2 抗体检测）测试抗体反应。确定并比较四种 POC 快速检测的时间依赖性检测灵敏度和血清转换的及时性。结果：症状出现 3 周后检测抗 SARS-CoV-2 抗体的四种检测的总体敏感性和特异性分别为 100% 和 100%。单独检测IgM和IgG的快速检测与检测联合总抗体（主要是IgM/IgG）的快速检测没有显着差异。就确定 COVID-19 血清转化所需的时间而言，四种 POC 快速检测之间没有显着差异。患有肺炎的 COVID19 患者表现出比非肺炎患者更短的血清转换时间。 结论：：虽然基于 LFIA 的 POC 抗体快速检测在检测 SARS-CoV-2 特异性抗体方面表现出可靠的性能，但这些检测的结果应在 COVID-19 感染的抗体动态背景下进行适当的解释和应用。合并肺炎的 COVID-19 患者比没有肺炎的 COVID-19 患者表现出更早的抗 SARS-CoV-2 抗体反应。 (C) 2020 英国感染协会。由爱思唯尔有限公司出版。保留所有权利。
Objectives:: We aimed to evaluate the role of rapid serological tests in the management of coronavirus disease 2019 (COVID-19) patients.Methods:: This retrospective study enrolled 16 real-time reverse transcription polymerase chain reactionconfirmed symptomatic patients with COVID-19 and 58 COVID-19 negative patients at a medical center in Taiwan over a 3 -month period. Serial serum samples were collected and tested for antibody response using four point-of-care (POC) lateral flow immunoassays (LFIA) (ALLTEST 2019-nCoV IgG/IgM Rapid Test, Dynamiker 2019-nCoV IgG/IgM Rapid Test, ASK COVID-19 IgG/IgM Rapid Test, and Wondfo SARS-CoV-2 Antibody Test). Time-dependent detection sensitivity and timeliness of seroconversion were determined and compared between the four POC rapid tests.Results:: The overall sensitivity and specificity of the four tests for detecting anti-SARS-CoV-2 antibodies after 3 weeks of symptom onset were 100% and 100%, respectively. There was no significant difference between the rapid tests used for detection of IgM and IgG separately and those used for detection of combined total antibody (mainly IgM/IgG). There was no significant difference between the four POC rapid tests in terms of time required for determining seroconversion of COVID-19. Patients with COVID19 with pneumonia demonstrated shorter seroconversion time than those without pneumonia.Conclusion:: Though the POC antibody rapid tests based on LFIA showed reliable performance in the detection of SARS-CoV-2-specific antibodies, the results of these tests should be interpreted and applied appropriately in the context of antibody dynamic of COVID-19 infection. COVID-19 patients complicated with pneumonia exhibited earlier anti-SARS-CoV-2 antibody response than COVID-19 patients without pneumonia. (C) 2020 The British Infection Association. Published by Elsevier Ltd. All rights reserved.