Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo, 162-8655, Japan.
Department of Respirology, National Center for Global Health and Medicine, Tokyo, 162-8655, Japan.
Int J Infect Dis. 2021 Mar;104:65-72. doi: 10.1016/j.ijid.2020.12.079. Epub 2021 Jan 2.
Rapid antigen testing (RAT) for coronavirus disease 2019 (COVID-19) has lower sensitivity but high accuracy during the early stage when compared to reverse transcription quantitative polymerase chain reaction (RT-qPCR). The aim of this study was to investigate the concordance between RAT and RT-qPCR results, and their prediction of disease transmission.
This single-center retrospective observational study of inpatients with COVID-19 was conducted from March 6 to June 14, 2020. Nasopharyngeal swabs were used to perform RAT and RT-qPCR. The primary endpoint was concordance between RAT and RT-qPCR results. The secondary endpoints were the factors causing disagreement in the results and the estimated transmissibility in RT-qPCR-positive patients with mild symptoms.
Overall, 229 samples in viral transport medium (VTM) were obtained from 105 patients. The positive and negative concordance rates for VTM were 41% vs 99% (κ = 0.37) and 72% vs 100% (κ = 0.50) for samples collected on disease days 2-9. An increased body temperature (odds ratio 0.54) and absence of drugs with potential antiviral effect (odds ratio 0.48) yielded conflicting results. RAT was associated with the ability to end isolation (OR 0.11, 95% confidence interval 0.20-0.61).
RAT and RT-qPCR results were highly consistent for samples collected at the appropriate time and could be useful for inferring the possibility of transmissibility.
与逆转录定量聚合酶链反应(RT-qPCR)相比,用于 2019 年冠状病毒病(COVID-19)的快速抗原检测(RAT)在早期具有较低的敏感性但具有较高的准确性。本研究旨在调查 RAT 与 RT-qPCR 结果的一致性及其对疾病传播的预测。
这是一项针对 COVID-19 住院患者的单中心回顾性观察研究,于 2020 年 3 月 6 日至 6 月 14 日进行。使用鼻咽拭子进行 RAT 和 RT-qPCR。主要终点是 RAT 与 RT-qPCR 结果的一致性。次要终点是导致结果不一致的因素以及 RT-qPCR 阳性轻症患者的估计传染性。
总体而言,从 105 名患者中获得了 229 份病毒转运培养基(VTM)样本。在疾病第 2-9 天采集的样本中,VTM 的阳性和阴性一致性率分别为 41%与 99%(κ=0.37)和 72%与 100%(κ=0.50)。体温升高(比值比 0.54)和无潜在抗病毒作用的药物(比值比 0.48)会导致结果不一致。RAT 与隔离结束的能力相关(OR 0.11,95%置信区间 0.20-0.61)。
在适当的时间采集样本时,RAT 与 RT-qPCR 结果高度一致,可用于推断传染性的可能性。