Program in Digital Medicine, Department of Medicine; Division of Health Systems Science, Department of Medicine; and Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, Massachusetts (A.S.).
Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, Massachusetts (C.H., C.P., P.S., T.O., C.W., S.T., S.B., A.F., S.P.).
Ann Intern Med. 2023 Jul;176(7):975-982. doi: 10.7326/M23-0385. Epub 2023 Jul 4.
The performance of rapid antigen tests (Ag-RDTs) for screening asymptomatic and symptomatic persons for SARS-CoV-2 is not well established.
To evaluate the performance of Ag-RDTs for detection of SARS-CoV-2 among symptomatic and asymptomatic participants.
This prospective cohort study enrolled participants between October 2021 and January 2022. Participants completed Ag-RDTs and reverse transcriptase polymerase chain reaction (RT-PCR) testing for SARS-CoV-2 every 48 hours for 15 days.
Participants were enrolled digitally throughout the mainland United States. They self-collected anterior nasal swabs for Ag-RDTs and RT-PCR testing. Nasal swabs for RT-PCR were shipped to a central laboratory, whereas Ag-RDTs were done at home.
Of 7361 participants in the study, 5353 who were asymptomatic and negative for SARS-CoV-2 on study day 1 were eligible. In total, 154 participants had at least 1 positive RT-PCR result.
The sensitivity of Ag-RDTs was measured on the basis of testing once (same-day), twice (after 48 hours), and thrice (after a total of 96 hours). The analysis was repeated for different days past index PCR positivity (DPIPPs) to approximate real-world scenarios where testing initiation may not always coincide with DPIPP 0. Results were stratified by symptom status.
Among 154 participants who tested positive for SARS-CoV-2, 97 were asymptomatic and 57 had symptoms at infection onset. Serial testing with Ag-RDTs twice 48 hours apart resulted in an aggregated sensitivity of 93.4% (95% CI, 90.4% to 95.9%) among symptomatic participants on DPIPPs 0 to 6. When singleton positive results were excluded, the aggregated sensitivity on DPIPPs 0 to 6 for 2-time serial testing among asymptomatic participants was lower at 62.7% (CI, 57.0% to 70.5%), but it improved to 79.0% (CI, 70.1% to 87.4%) with testing 3 times at 48-hour intervals.
Participants tested every 48 hours; therefore, these data cannot support conclusions about serial testing intervals shorter than 48 hours.
The performance of Ag-RDTs was optimized when asymptomatic participants tested 3 times at 48-hour intervals and when symptomatic participants tested 2 times separated by 48 hours.
National Institutes of Health RADx Tech program.
快速抗原检测（Ag-RDT）用于筛查无症状和有症状的 SARS-CoV-2 患者的效果尚未得到充分证实。
评估 Ag-RDT 检测有症状和无症状参与者中 SARS-CoV-2 的性能。
这项前瞻性队列研究招募了 2021 年 10 月至 2022 年 1 月期间的参与者。参与者每 48 小时完成一次 Ag-RDT 和逆转录聚合酶链反应（RT-PCR）检测 SARS-CoV-2，共 15 天。
参与者通过数字方式遍布美国大陆招募。他们自行采集前鼻拭子进行 Ag-RDT 和 RT-PCR 检测。用于 RT-PCR 的鼻拭子被运送到一个中央实验室，而 Ag-RDT 则在家里进行。
在研究中，共有 7361 名参与者，其中 5353 名在研究第 1 天无症状且 SARS-CoV-2 检测结果为阴性，符合条件。共有 154 名参与者至少有 1 次 RT-PCR 检测结果为阳性。
根据单次（当日）、两次（48 小时后）和三次（总共 96 小时后）检测来测量 Ag-RDT 的敏感性。为了近似于检测启动不一定总是与 DPIPP 0 同时发生的真实情况，针对不同的过去指数 PCR 阳性天数（DPIPPs）重复了分析。结果按症状状态分层。
在 154 名 SARS-CoV-2 检测阳性的参与者中，97 名无症状，57 名在感染初期出现症状。两次 48 小时间隔的 Ag-RDT 重复检测在 DPIPPs 0 至 6 时，症状性参与者的汇总敏感性为 93.4%（95%CI，90.4%至 95.9%）。当排除单阳性结果时，无症状参与者两次重复检测在 DPIPPs 0 至 6 的汇总敏感性较低，为 62.7%（CI，57.0%至 70.5%），但在 48 小时间隔三次检测时，敏感性提高至 79.0%（CI，70.1%至 87.4%）。
参与者每 48 小时检测一次；因此，这些数据不能支持关于间隔小于 48 小时的重复检测的结论。
无症状参与者每 48 小时检测 3 次，有症状参与者每 48 小时检测 2 次时，Ag-RDT 的性能得到优化。
美国国立卫生研究院 RADxTech 计划。
