Soni Apurv, Herbert Carly, Pretz Caitlin, Stamegna Pamela, Filippaios Andreas, Shi Qiming, Suvarna Thejas, Harman Emma, Schrader Summer, Nowak Chris, Schramm Eric, Kheterpal Vik, Behar Stephanie, Tarrant Seanan, Ferranto Julia, Hafer Nathaniel, Robinson Matthew, Achenbach Chad, Murphy Robert L, Manabe Yukari C, Gibson Laura, Barton Bruce, O'Connor Laurel, Fahey Nisha, Orvek Elizabeth, Lazar Peter, Ayturk Didem, Wong Steven, Zai Adrian, Cashman Lisa, Rao Lokinendi V, Luzuriaga Katherine, Lemon Stephenie, Blodgett Allison, Trippe Elizabeth, Barcus Mary, Goldberg Brittany, Roth Kristian, Stenzel Timothy, Heetderks William, Broach John, McManus David
medRxiv. 2023 Jan 23:2022.08.04.22278274. doi: 10.1101/2022.08.04.22278274.
Rapid antigen tests (Ag-RDT) for SARS-CoV-2 with Emergency Use Authorization generally include a condition of authorization to evaluate the test's performance in asymptomatic individuals when used serially.
To describe a novel study design to generate regulatory-quality data to evaluate serial use of Ag-RDT in detecting SARS-CoV-2 virus among asymptomatic individuals.
Prospective cohort study using a decentralized approach. Participants were asked to test using Ag-RDT and molecular comparators every 48 hours for 15 days.
Participants throughout the mainland United States were enrolled through a digital platform between October 18, 2021 and February 15, 2022. Ag-RDTs were completed at home, and molecular comparators were shipped to a central laboratory.
Individuals over 2 years old from across the U.S. with no reported COVID-19 symptoms in the 14 days prior to study enrollment were eligible to enroll in this study.
Enrollment demographics, geographic distribution, and SARS-CoV-2 infection rates are reported.
A total of 7,361 participants enrolled in the study, and 492 participants tested positive for SARS-CoV-2, including 154 who were asymptomatic and tested negative to start the study. This exceeded the initial enrollment goals of 60 positive participants. We enrolled participants from 44 U.S. states, and geographic distribution of participants shifted in accordance with the changing COVID-19 prevalence nationwide.
New, complex workflows required significant operational and data team support. Conclusions: The digital site-less approach employed in the 'Test Us At Home' study enabled rapid, efficient, and rigorous evaluation of rapid diagnostics for COVID-19, and can be adapted across research disciplines to optimize study enrollment and accessibility.
获得紧急使用授权的新型冠状病毒2019（SARS-CoV-2）快速抗原检测（Ag-RDT）通常包含一项授权条件，即连续使用时需评估该检测在无症状个体中的性能。
描述一种新型研究设计，以生成监管级质量的数据，用于评估连续使用Ag-RDT在无症状个体中检测SARS-CoV-2病毒的情况。
采用分散式方法的前瞻性队列研究。参与者被要求每48小时使用Ag-RDT和分子对照检测，持续15天。
2021年10月18日至2022年2月15日期间，通过数字平台招募了美国大陆各地的参与者。Ag-RDT在家中完成，分子对照样本被送往中央实验室。
在研究入组前14天内无新冠病毒病（COVID-19）症状报告的2岁以上美国各地个体有资格参与本研究。
报告入组人口统计学、地理分布和SARS-CoV-2感染率。
共有7361名参与者入组本研究，492名参与者SARS-CoV-2检测呈阳性，其中154名无症状且在研究开始时检测呈阴性。这超过了最初60名阳性参与者的入组目标。我们从美国44个州招募了参与者，参与者的地理分布随着全国COVID-19患病率的变化而变化。
新的复杂工作流程需要大量运营和数据团队的支持。结论：“在家检测我们”研究中采用的无现场数字方法能够快速、高效且严格地评估COVID-19的快速诊断方法，并且可以应用于各个研究领域，以优化研究入组和可及性。
