基于症状发作和密切接触暴露的新型冠状病毒2诊断性能：来自“在家检测我们”前瞻性队列研究的分析
Performance of and Severe Acute Respiratory Syndrome Coronavirus 2 Diagnostics Based on Symptom Onset and Close Contact Exposure: An Analysis From the Test Us at Home Prospective Cohort Study.
作者信息
Herbert Carly, Wang Biqi, Lin Honghuang, Yan Yi, Hafer Nathaniel, Pretz Caitlin, Stamegna Pamela, Wright Colton, Suvarna Thejas, Harman Emma, Schrader Summer, Nowak Chris, Kheterpal Vik, Orvek Elizabeth, Wong Steven, Zai Adrian, Barton Bruce, Gerber Ben S, Lemon Stephenie C, Filippaios Andreas, Gibson Laura, Greene Sharone, Colubri Andres, Achenbach Chad, Murphy Robert, Heetderks William, Manabe Yukari C, O'Connor Laurel, Fahey Nisha, Luzuriaga Katherine, Broach John, Roth Kristian, McManus David D, Soni Apurv
机构信息
Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA.
University of Massachusetts Center for Clinical and Translational Science, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA.
出版信息
Open Forum Infect Dis. 2024 May 31;11(6):ofae304. doi: 10.1093/ofid/ofae304. eCollection 2024 Jun.
BACKGROUND
Understanding changes in diagnostic performance after symptom onset and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposure within different populations is crucial to guide the use of diagnostics for SARS-CoV-2.
METHODS
The Test Us at Home study was a longitudinal cohort study that enrolled individuals across the United States between October 2021 and February 2022. Participants performed paired antigen-detection rapid diagnostic tests (Ag-RDTs) and reverse-transcriptase polymerase chain reaction (RT-PCR) tests at home every 48 hours for 15 days and self-reported symptoms and known coronavirus disease 2019 exposures immediately before testing. The percent positivity for Ag-RDTs and RT-PCR tests was calculated each day after symptom onset and exposure and stratified by vaccination status, variant, age category, and sex.
RESULTS
The highest percent positivity occurred 2 days after symptom onset (RT-PCR, 91.2%; Ag-RDT, 71.1%) and 6 days after exposure (RT-PCR, 91.8%; Ag-RDT, 86.2%). RT-PCR and Ag-RDT performance did not differ by vaccination status, variant, age category, or sex. The percent positivity for Ag-RDTs was lower among exposed, asymptomatic than among symptomatic individuals (37.5% (95% confidence interval [CI], 13.7%-69.4%) vs 90.3% (75.1%-96.7%). Cumulatively, Ag-RDTs detected 84.9% (95% CI, 78.2%-89.8%) of infections within 4 days of symptom onset. For exposed participants, Ag-RDTs detected 94.0% (95% CI, 86.7%-97.4%) of RT-PCR-confirmed infections within 6 days of exposure.
CONCLUSIONS
The percent positivity for Ag-RDTs and RT-PCR tests was highest 2 days after symptom onset and 6 days after exposure, and performance increased with serial testing. The percent positivity of Ag-RDTs was lowest among asymptomatic individuals but did not differ by sex, variant, vaccination status, or age category.
背景
了解症状出现后以及严重急性呼吸综合征冠状病毒2（SARS-CoV-2）暴露后不同人群诊断性能的变化对于指导SARS-CoV-2诊断方法的使用至关重要。
方法
“在家检测我们”研究是一项纵向队列研究，于2021年10月至2022年2月在美国招募个体。参与者每48小时在家中进行一次配对的抗原检测快速诊断试验（Ag-RDT）和逆转录聚合酶链反应（RT-PCR）试验，持续15天，并在每次检测前自行报告症状以及已知的2019冠状病毒病暴露情况。在症状出现和暴露后每天计算Ag-RDT和RT-PCR试验的阳性率，并按疫苗接种状况、病毒变体、年龄类别和性别进行分层。
结果
阳性率最高出现在症状出现后2天（RT-PCR为91.2%；Ag-RDT为71.1%）以及暴露后6天（RT-PCR为91.8%；Ag-RDT为86.2%）。RT-PCR和Ag-RDT的性能在疫苗接种状况、病毒变体、年龄类别或性别方面没有差异。暴露的无症状个体中Ag-RDT的阳性率低于有症状个体（37.5%（95%置信区间[CI]，13.7%-69.4%）对90.3%（75.1%-96.7%））。累计来看，Ag-RDT在症状出现后4天内检测到84.9%（95%CI，78.2%-89.8%）的感染。对于暴露的参与者，Ag-RDT在暴露后6天内检测到94.0%（95%CI，86.7%-97.4%）的RT-PCR确诊感染。
结论
Ag-RDT和RT-PCR试验的阳性率在症状出现后2天和暴露后第6天最高，并且通过连续检测性能有所提高。Ag-RDT的阳性率在无症状个体中最低，但在性别、病毒变体、疫苗接种状况或年龄类别方面没有差异。
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