Clinical validation of quantitative SARS-CoV-2 antigen assays to estimate SARS-CoV-2 viral loads in nasopharyngeal swabs.
Clinical validation of quantitative SARS-CoV-2 antigen assays to estimate SARS-CoV-2 viral loads in nasopharyngeal swabs.
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DOI：
10.1016/j.jiac.2020.11.021
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发表时间：
2021-04
期刊：
影响因子：
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通讯作者：
Tateda K
中科院分区：
文献类型：
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作者：
Aoki K;Nagasawa T;Ishii Y;Yagi S;Okuma S;Kashiwagi K;Maeda T;Miyazaki T;Yoshizawa S;Tateda K
扩大严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 的检测能力是缓解该病毒引起的 2019 冠状病毒病 (COVID-19) 大流行的一个重要问题。最近，开发了一种灵敏的定量抗原测试 (SQT) Lumipulse® SARS-CoV-2 Ag。它是针对 SARS-CoV-2 的全自动化学发光酶免疫分析系统。在本研究中，使用逆转录聚合酶链反应 (RT-PCR) 作为对照，使用鼻咽拭子的临床标本检查了 SQT 的分析性能。对 24 名 SARS-CoV-2 阳性和 524 名阴性患者的接受者操作特征分析显示，曲线下面积为 0.957 ± 0.063。使用 1.34 pg/ml 的临界值，敏感性为 91.7%，特异性为 98.5%，总体一致性率为 98.2%。在阴性病例的分布中，99.5 百分位数值为 1.03 pg/ml。使用RT-PCR循环阈值计算的病毒载量与抗原浓度之间存在高度相关性。疾病发作后抗原浓度随时间降低的趋势与病毒载量相关。目前的结果表明，SQT 与 RT-PCR 高度一致，对于任何临床环境中的 COVID-19 诊断都应该有用。因此，这款全自动试剂盒将有助于扩大 SARS-CoV-2 的检测能力。
Expansion of the testing capacity for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an important issue to mitigate the pandemic of coronavirus disease-2019 (COVID-19) caused by this virus. Recently, a sensitive quantitative antigen test (SQT), Lumipulse® SARS-CoV-2 Ag, was developed. It is a fully automated chemiluminescent enzyme immunoassay system for SARS-CoV-2. In this study, the analytical performance of SQT was examined using clinical specimens from nasopharyngeal swabs using reverse transcription polymerase chain reaction (RT-PCR) as a control. Receiver operating characteristic analysis of 24 SARS-CoV-2-positive and 524 -negative patients showed an area under the curve of 0.957 ± 0.063. Using a cut-off value of 1.34 pg/ml, the sensitivity was 91.7%, the specificity was 98.5%, and the overall rate of agreement was 98.2%. In the distribution of negative cases, the 99.5 percentile value was 1.03 pg/ml. There was a high correlation between the viral load calculated using the cycle threshold value of RT-PCR and the concentration of antigen. The tendency for the antigen concentration to decrease with time after disease onset correlated with that of the viral load. Presented results indicate that SQT is highly concordant with RT-PCR and should be useful for the diagnosis of COVID-19 in any clinical setting. Therefore, this fully automated kit will contribute to the expansion of the testing capability for SARS-CoV-2.