对COVID-19的各种诊断测试进行适当的解释至关重要，然而快速抗原测试之间的联系，逆转录（RT）-PCR，病毒培养尚未完全定义。为了确定快速抗原检测是否与成人中具有复制能力的严重急性呼吸道综合征冠状病毒2（SARS-CoV-2）的存在和数量相关，626名成人参与者参加了一项横断面诊断研究。每位参与者都获得了两个前鼻拭子，用于快速抗原和RT-PCR测试以及SARS-CoV-2病毒培养。主要结果是无症状和有症状的成人中VeroE6-ACE2-TMPRSS2细胞中SARS-CoV-2生长的存在和定量。在这项对626名成人门诊病人的横断面研究中，在无症状参与者中,单一抗原阳性试验对鉴定有复制能力的SARS-CoV-2的敏感性为63.6%,在有症状参与者中为91.0%.病毒培养滴度在症状发作时最高，在症状发作后7天迅速下降。在周期阈值CT小于30的情况下，快速抗原测试与RT-PCR的阳性一致性在无症状参与者中为66.7％，在有症状参与者中为90.7％。在CT小于30的有症状的参与者中，单抗原测试的阳性一致性为90.7％（95％置信区间[CI]，84.8%至94.8%）。所有425名RT-PCR阴性参与者的抗原测试均为阴性，因此具有100％的阴性一致性。有症状的成人COVID-19的抗原检测阳性与具有复制能力的SARS-CoV-2密切相关。快速抗原测试结果可能是感染性的合适代表。重要性快速抗原测试结果是否与具有复制能力的严重急性呼吸道综合症冠状病毒2（SARS-CoV-2）（即传染性）病毒？在这项对626名成年人的横断面诊断研究中，在无症状参与者中,抗原试验对鉴定有复制能力的SARS-CoV-2的敏感性为63.6%,在有症状参与者中为91.0%.病毒培养滴度在症状发作时最高，在症状发作后7天迅速下降。在CT小于30的情况下，快速抗原测试与逆转录（RT）-PCR的阳性一致性在无症状参与者中为66.7％，在有症状参与者中为90.7％。阳性抗原测试可能是鉴定有症状的COVID-19个体中具有复制能力的病毒的适当替代方法。
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 CT less than 30 was 66.7% in asymptomatic and 90.7% in symptomatic participants. Among symptomatic participants a with a CT 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. IMPORTANCE 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 CT 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.
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