Soni Apurv, Herbert Carly, Lin Honghuang, Yan Yi, Pretz Caitlin, Stamegna Pamela, Wang Biqi, Orwig Taylor, Wright Colton, Tarrant Seanan, Behar Stephanie, Suvarna Thejas, Schrader Summer, Harman Emma, Nowak Chris, Kheterpal Vik, Rao Lokinendi V, Cashman Lisa, Orvek Elizabeth, Ayturk Didem, Gibson Laura, Zai Adrian, Wong Steven, Lazar Peter, Wang Ziyue, Filippaios Andreas, Barton Bruce, Achenbach Chad J, Murphy Robert L, Robinson Matthew, Manabe Yukari C, Pandey Shishir, Colubri Andres, Oâ Connor Laurel, Lemon Stephenie C, Fahey Nisha, Luzuriaga Katherine L, Hafer Nathaniel, Roth Kristian, Lowe Toby, Stenzel Timothy, Heetderks William, Broach John, McManus David D
medRxiv. 2023 Jan 23:2022.08.05.22278466. doi: 10.1101/2022.08.05.22278466.
Performance of rapid antigen tests for SARS-CoV-2 (Ag-RDT) varies over the course of an infection, and their performance in screening for SARS-CoV-2 is not well established. We aimed to evaluate performance of Ag-RDT for detection of SARS-CoV-2 for symptomatic and asymptomatic participants.
Participants >2 years old across the United States enrolled in the study between October 2021 and February 2022. Participants completed Ag-RDT and molecular testing (RT-PCR) for SARS-CoV-2 every 48 hours for 15 days. This analysis was limited to participants who were asymptomatic and tested negative on their first day of study participation. Onset of infection was defined as the day of first positive RT-PCR result. Sensitivity of Ag-RDT was measured based on testing once, twice (after 48-hours), and thrice (after 96 hours). Analysis was repeated for different Days Post Index PCR Positivity (DPIPP) and stratified based on symptom-status.
In total, 5,609 of 7,361 participants were eligible for this analysis. Among 154 participants who tested positive for SARS-CoV-2, 97 were asymptomatic and 57 had symptoms at infection onset. Serial testing with Ag-RDT twice 48-hours apart resulted in an aggregated sensitivity of 93.4% (95% CI: 89.1-96.1%) among symptomatic participants on DPIPP 0-6. Excluding singleton positives, aggregated sensitivity on DPIPP 0-6 for two-time serial-testing among asymptomatic participants was lower at 62.7% (54.7-70.0%) but improved to 79.0% (71.0-85.3%) with testing three times at 48-hour intervals.
Performance of Ag-RDT was optimized when asymptomatic participants tested three-times at 48-hour intervals and when symptomatic participants tested two-times separated by 48-hours.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）快速抗原检测（Ag-RDT）的性能在感染过程中会有所不同，其在SARS-CoV-2筛查中的性能尚未得到充分证实。我们旨在评估Ag-RDT对有症状和无症状参与者检测SARS-CoV-2的性能。
2021年10月至2022年2月期间，美国各地年龄大于2岁的参与者纳入本研究。参与者每48小时完成一次针对SARS-CoV-2的Ag-RDT和分子检测（逆转录-聚合酶链反应，RT-PCR），持续15天。该分析仅限于无症状且在参与研究首日检测为阴性的参与者。感染发作定义为首次RT-PCR结果呈阳性的日期。Ag-RDT的敏感性基于一次、两次（48小时后）和三次（96小时后）检测进行测量。针对不同的索引PCR阳性后天数（DPIPP）重复分析，并根据症状状态进行分层。
7361名参与者中，共有5609名符合该分析条件。在154名SARS-CoV-2检测呈阳性的参与者中，97名无症状，57名在感染发作时有症状。对于有症状的参与者，在DPIPP 0-6时，每隔48小时进行两次Ag-RDT连续检测，综合敏感性为93.4%（95%置信区间：89.1-96.1%）。排除单次阳性病例后，无症状参与者在DPIPP 0-6时进行两次连续检测的综合敏感性较低，为62.7%（54.7-70.0%），但每隔48小时进行三次检测时，敏感性提高到79.0%（71.0-85.3%）。
无症状参与者每隔48小时进行三次检测，以及有症状参与者每隔48小时进行两次检测时，Ag-RDT的性能得到优化。
