Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients
Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients
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DOI：
10.1016/j.ijid.2020.08.029
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发表时间：
2020-10-01
影响因子：
8.4
通讯作者：
Omata, Masao
中科院分区：
文献类型：
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作者：
Hirotsu, Yosuke;Maejima, Makoto;Omata, Masao
在常规临床实践中，严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染通过逆转录PCR（RT-PCR）确定。在当前的大流行中，对更快速和高通量的方法的需求日益增加。在这里，我们验证了基于化学发光酶免疫分析的新抗原检测（LUMIPULSE）的性能。采用定量RT-PCR（RT-qPCR）分析了313份鼻咽拭子（来自7名感染患者的82份系列样本和来自4名感染患者和215名未感染个体的231份个体样本）中的SARS-CoV-2，然后进行LUMIPULSE检测。我们使用受试者工作特征曲线分析确定了抗原检测的临界值，并将抗原检测的性能与RT-qPCR的性能进行了比较。我们还比较了来自7名感染患者的系列样本中的病毒载量和抗原水平。以RT-qPCR为参考，抗原检测的敏感性为55.2%，特异性为99.6%，总体符合率为91.4%（286/313）。在病毒拷贝数> 100和拷贝数在10 - 100之间的标本中，抗原检测与RT-qPCR的一致性分别为100%和85%。这种一致性随着病毒载量的降低而下降。在连续随访的患者中，抗原水平显示稳定下降，沿着病毒清除。这种逐渐下降与使用RT-qPCR观察到的突然的阳性到阴性和阴性到阳性状态变化形成对比，特别是在感染的晚期。总之，LUMIPULSE抗原检测可以快速识别具有中度至高度病毒载量的SARS-CoV-2感染个体，并可能有助于监测住院患者的病毒清除。(C)2020作者（S）由爱思唯尔有限公司代表国际传染病学会出版。
In routine clinical practice, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is determined by reverse-transcription PCR (RT-PCR). In the current pandemic, a more rapid and high-throughput method is in growing demand. Here, we validated the performance of a new antigen test (LUMIPULSE) based on chemiluminescence enzyme immunoassay. A total of 313 nasopharyngeal swabs (82 serial samples from 7 infected patients and 231 individual samples from 4 infected patients and 215 uninfected individuals) were analyzed for SARS-CoV-2 with quantitative RT-PCR (RT-qPCR) and then subjected to LUMIPULSE. We determined the cutoff value for antigen detection using receiver operating characteristic curve analysis and compared the performance of the antigen test with that of RT-qPCR. We also compared the viral loads and antigen levels in serial samples from seven infected patients. Using RT-qPCR as the reference, the antigen test exhibited 55.2% sensitivity and 99.6% specificity, with a 91.4% overall agreement rate (286/313). In specimens with > 100 viral copies and between 10 and 100 copies, the antigen test showed 100% and 85% concordance with RT-qPCR, respectively. This concordance declined with lower viral loads. In the serially followed patients, the antigen levels showed a steady decline, along with viral clearance. This gradual decline was in contrast with the abrupt positive-to-negative and negative-to-positive status changes observed with RT-qPCR, particularly in the late phase of infection. In summary, the LUMIPULSE antigen test can rapidly identify SARS-CoV-2-infected individuals with moderate to high viral loads and may be helpful for monitoring viral clearance in hospitalized patients. (C) 2020 The Author(s). Published by Elsevier Ltd on behalf of International Society for Infectious Diseases.