Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington, Seattle, Washington, USA.
Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, New York, USA.
J Infect Dis. 2024 Aug 16;230(2):363-373. doi: 10.1093/infdis/jiae150.
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.
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).
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.
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.
SARS-CoV-2 抗原检测快速诊断检测（Ag-RDT）已被广泛应用，但基于社区的性能的纵向特征仍不完全清楚。
本研究在华盛顿州西雅图的一所大型公立大学进行了前瞻性纵向研究，利用远程入组、在线调查和自我采集的鼻腔拭子标本，评估了在 SARS-CoV-2 奥密克戎流行背景下，Ag-RDT 与实时逆转录聚合酶链反应（rRT-PCR）的比较性能。通过整个疾病发作期间的症状状态和 Orf1b 循环阈值（Ct），评估了 rRT-PCR 后 1 天内的 Ag-RDT 敏感性和特异性。
从 2022 年 2 月至 12 月，5757 名参与者报告了 17572 次 Ag-RDT 结果，并完成了 12674 次 rRT-PCR 检测，其中 995 次（7.9%）为 rRT-PCR 阳性。总体敏感性和特异性分别为 53.0%（95%置信区间[CI]，49.6%-56.4%）和 98.8%（95% CI，98.5%-99.0%）。在 rRT-PCR 后 1 天（69.0%）、症状发作后 4-7 天（70.1%）和 Orf1b Ct ≤20（82.7%）时，Ag-RDT 的敏感性相对较高。在初始 Ag-RDT 阴性结果后重复检测≥2（68.5%）和≥4（75.8%）天时，Ag-RDT 的敏感性呈递增趋势。
Ag-RDT 的性能因临床特征和时间检测模式而异。我们的研究结果支持在初始 Ag-RDT 阴性结果后进行重复检测的建议，尤其是在最近出现症状的人群或 SARS-CoV-2 感染风险较高的人群中。
