Department of Microbiology and Infectious Diseases, Toho University School of Medicine, 5-21-16 Omori-nishi, Ota-ku, 143-8540, Tokyo, Japan.
Department of Microbiology and Infectious Diseases, Toho University School of Medicine, 5-21-16 Omori-nishi, Ota-ku, 143-8540, Tokyo, Japan.
J Infect Chemother. 2021 Apr;27(4):613-616. doi: 10.1016/j.jiac.2020.11.021. Epub 2020 Dec 3.
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.
扩大严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）的检测能力是减轻由该病毒引起的 2019 年冠状病毒病（COVID-19）大流行的重要问题。最近，一种灵敏的定量抗原检测（SQT），即 Lumipulse®SARS-CoV-2Ag 被开发出来。它是一种用于 SARS-CoV-2 的全自动化学发光酶免疫分析系统。
在这项研究中，使用鼻咽拭子的临床标本，以逆转录聚合酶链反应（RT-PCR）作为对照，对 SQT 的分析性能进行了检查。
对 24 例 SARS-CoV-2 阳性和 524 例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 1.34pg/ml 的截断值，灵敏度为 91.7%，特异性为 98.5%，总符合率为 98.2%。在阴性病例的分布中，99.5%分位数值为 1.03pg/ml。用 RT-PCR 的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下降的趋势与病毒载量的趋势相关。
目前的结果表明，SQT 与 RT-PCR 高度一致，应该有助于任何临床环境下 COVID-19 的诊断。因此，这种全自动试剂盒将有助于扩大 SARS-CoV-2 的检测能力。
