Abstract：
BACKGROUND: SARS-CoV-2 antigen-detection rapid diagnostic tests (Ag-RDTs) have become widely utilized but longitudinal characterization of their community-based performance remains incompletely understood.
METHODS: This prospective longitudinal study at a large public university in Seattle, WA utilized remote enrollment, online surveys, and self-collected nasal swab specimens to evaluate Ag-RDT performance against real-time reverse transcription polymerase chain reaction (rRT-PCR) in the context of SARS-CoV-2 Omicron. Ag-RDT sensitivity and specificity within 1 day of rRT-PCR were evaluated by symptom status throughout the illness episode and Orf1b cycle threshold (Ct).
RESULTS: From February to December 2022, 5757 participants reported 17 572 Ag-RDT results and completed 12 674 rRT-PCR tests, of which 995 (7.9%) were rRT-PCR positive. Overall sensitivity and specificity were 53.0% (95% confidence interval [CI], 49.6%-56.4%) and 98.8% (95% CI, 98.5%-99.0%), respectively. Sensitivity was comparatively higher for Ag-RDTs used 1 day after rRT-PCR (69.0%), 4-7 days after symptom onset (70.1%), and Orf1b Ct ≤20 (82.7%). Serial Ag-RDT sensitivity increased with repeat testing ≥2 (68.5%) and ≥4 (75.8%) days after an initial Ag-RDT-negative result.
CONCLUSIONS: Ag-RDT performance varied by clinical characteristics and temporal testing patterns. Our findings support recommendations for serial testing following an initial Ag-RDT-negative result, especially among recently symptomatic persons or those at high risk for SARS-CoV-2 infection.
METHODS: This prospective longitudinal study at a large public university in Seattle, WA utilized remote enrollment, online surveys, and self-collected nasal swab specimens to evaluate Ag-RDT performance against real-time reverse transcription polymerase chain reaction (rRT-PCR) in the context of SARS-CoV-2 Omicron. Ag-RDT sensitivity and specificity within 1 day of rRT-PCR were evaluated by symptom status throughout the illness episode and Orf1b cycle threshold (Ct).
RESULTS: From February to December 2022, 5757 participants reported 17 572 Ag-RDT results and completed 12 674 rRT-PCR tests, of which 995 (7.9%) were rRT-PCR positive. Overall sensitivity and specificity were 53.0% (95% confidence interval [CI], 49.6%-56.4%) and 98.8% (95% CI, 98.5%-99.0%), respectively. Sensitivity was comparatively higher for Ag-RDTs used 1 day after rRT-PCR (69.0%), 4-7 days after symptom onset (70.1%), and Orf1b Ct ≤20 (82.7%). Serial Ag-RDT sensitivity increased with repeat testing ≥2 (68.5%) and ≥4 (75.8%) days after an initial Ag-RDT-negative result.
CONCLUSIONS: Ag-RDT performance varied by clinical characteristics and temporal testing patterns. Our findings support recommendations for serial testing following an initial Ag-RDT-negative result, especially among recently symptomatic persons or those at high risk for SARS-CoV-2 infection.
摘要：
背景：SARS-CoV-2抗原检测快速诊断测试（Ag-RDTs）已被广泛使用，但其基于社区的性能的纵向表征仍未完全了解。
方法：这项在西雅图一所大型公立大学进行的前瞻性纵向研究，WA利用远程注册，在线调查,和自我收集的鼻拭子标本，以评估在SARS-CoV-2Omicron的背景下Ag-RDT对实时逆转录聚合酶链反应（rRT-PCR）的性能。通过整个疾病发作的症状状态和Orf1b周期阈值（Ct）评估rRT-PCR的1天内的Ag-RDT敏感性和特异性。
结果：从2022年2月至12月，5757名参与者报告了17572Ag-RDT结果，并完成了12674rRT-PCR测试，其中rRT-PCR阳性995例(7.9%)。总体敏感性和特异性为53.0%(95%置信区间[CI]，49.6%-56.4%）和98.8%（95%CI，98.5%-99.0%），分别。rRT-PCR后1天使用Ag-RDT的敏感性相对较高（69.0％），症状发作后4-7天（70.1%），和Orf1bCt≤20（82.7%）。在初始Ag-RDT阴性结果后，重复测试≥2（68.5％）和≥4（75.8％）天，系列Ag-RDT敏感性增加。
结论：Ag-RDT表现因临床特征和时间检测模式而异。我们的发现支持在初始Ag-RDT阴性结果后进行系列测试的建议，特别是在最近有症状的人或SARS-CoV-2感染的高危人群中。
方法：这项在西雅图一所大型公立大学进行的前瞻性纵向研究，WA利用远程注册，在线调查,和自我收集的鼻拭子标本，以评估在SARS-CoV-2Omicron的背景下Ag-RDT对实时逆转录聚合酶链反应（rRT-PCR）的性能。通过整个疾病发作的症状状态和Orf1b周期阈值（Ct）评估rRT-PCR的1天内的Ag-RDT敏感性和特异性。
结果：从2022年2月至12月，5757名参与者报告了17572Ag-RDT结果，并完成了12674rRT-PCR测试，其中rRT-PCR阳性995例(7.9%)。总体敏感性和特异性为53.0%(95%置信区间[CI]，49.6%-56.4%）和98.8%（95%CI，98.5%-99.0%），分别。rRT-PCR后1天使用Ag-RDT的敏感性相对较高（69.0％），症状发作后4-7天（70.1%），和Orf1bCt≤20（82.7%）。在初始Ag-RDT阴性结果后，重复测试≥2（68.5％）和≥4（75.8％）天，系列Ag-RDT敏感性增加。
结论：Ag-RDT表现因临床特征和时间检测模式而异。我们的发现支持在初始Ag-RDT阴性结果后进行系列测试的建议，特别是在最近有症状的人或SARS-CoV-2感染的高危人群中。
