The Everett Clinic - Part of Optum, Everett, Washington, USA.
Abbott Laboratories, Abbott Park, Illinois, USA.
Microbiol Spectr. 2023 Jun 15;11(3):e0006423. doi: 10.1128/spectrum.00064-23. Epub 2023 Apr 25.
Appropriate interpretation of various diagnostic tests for COVID-19 is critical, yet the association among rapid antigen tests, reverse transcription (RT)-PCR, and viral culture has not been fully defined. To determine whether rapid antigen testing correlates with the presence and quantity of replication-competent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in ambulatory adults, 626 adult participants were enrolled in a cross-sectional diagnostic study. Each participant had two anterior nasal swabs obtained for rapid antigen and RT-PCR testing and SARS-CoV-2 viral culture. The primary outcomes were the presence and quantification of SARS-CoV-2 growth in VeroE6-ACE2-TMPRSS2 cells in asymptomatic and symptomatic ambulatory adults. In this cross-sectional study of 626 adult outpatients, the sensitivity of a single positive antigen test to identify replication-competent SARS-CoV-2 was 63.6% in asymptomatic and 91.0% in symptomatic participants. Viral culture titers were the highest at the onset of symptoms and rapidly declined by 7 days after symptom onset. The positive agreement of the rapid antigen test with RT-PCR at a cycle threshold less than 30 was 66.7% in asymptomatic and 90.7% in symptomatic participants. Among symptomatic participants a with a less than 30, a single antigen test had a positive agreement of 90.7% (95% confidence interval [CI], 84.8% to 94.8%). There was 100% negative agreement as all 425 RT-PCR-negative participants had a negative antigen test. A positive antigen test in symptomatic adults with COVID-19 has a strong correlation with replication-competent SARS-CoV-2. Rapid antigen test results may be a suitable proxy for infectiousness. Do rapid antigen test results correlate with replication-competent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (i.e., infectious) virus? In this cross-sectional diagnostic study of 626 adults, the sensitivity of the antigen test to identify replication-competent SARS-CoV-2 was 63.6% in asymptomatic and 91.0% in symptomatic participants. Viral culture titers were the highest at the onset of symptoms and rapidly declined by 7 days after symptom onset. The positive agreement of the rapid antigen test with reverse transcription (RT)-PCR at a of less than 30 was 66.7% in asymptomatic participants and 90.7% in symptomatic participants. A positive antigen test may be an appropriate surrogate for identifying replication-competent virus in symptomatic individuals with COVID-19.
快速抗原检测与复制型严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）在门诊成人中的相关性研究
确定快速抗原检测是否与无症状和有症状的门诊成人中复制型严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）的存在和数量相关。
本横断面诊断研究纳入了 626 名成年参与者。每个参与者都进行了两次前鼻拭子，用于快速抗原和 RT-PCR 检测以及 SARS-CoV-2 病毒培养。主要结局是无症状和有症状的门诊成年人中 VeroE6-ACE2-TMPRSS2 细胞中 SARS-CoV-2 生长的存在和定量。
在这项针对 626 名门诊成年患者的横断面研究中，无症状和有症状患者中，单次抗原检测阳性识别复制型 SARS-CoV-2 的敏感性分别为 63.6%和 91.0%。在症状出现时，病毒培养滴度最高，并在症状出现后 7 天迅速下降。在 RT-PCR 循环阈值<30 的情况下，快速抗原检测与 RT-PCR 的阳性符合率在无症状患者中为 66.7%，在有症状患者中为 90.7%。在有症状的患者中，循环阈值<30 的情况下，单次抗原检测的阳性符合率为 90.7%（95%置信区间 [CI]，84.8%至 94.8%）。所有 425 名 RT-PCR 阴性的参与者的抗原检测均为阴性，其阴性符合率为 100%。在患有 COVID-19 的有症状成人中，阳性抗原检测与复制型 SARS-CoV-2 具有很强的相关性。快速抗原检测结果可能是传染性的合适替代指标。
快速抗原检测结果与复制型严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）（即传染性）病毒相关吗？在这项针对 626 名成年人的横断面诊断研究中，抗原检测识别复制型 SARS-CoV-2 的敏感性在无症状患者中为 63.6%，在有症状患者中为 91.0%。在症状出现时，病毒培养滴度最高，并在症状出现后 7 天迅速下降。在 RT-PCR 循环阈值<30 的情况下，快速抗原检测与 RT-PCR 的阳性符合率在无症状患者中为 66.7%，在有症状患者中为 90.7%。在患有 COVID-19 的有症状个体中，阳性抗原检测可能是识别复制型病毒的合适替代指标。
