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
Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA.
J Clin Transl Sci. 2023 May 10;7(1):e120. doi: 10.1017/cts.2023.540. eCollection 2023.
Rapid antigen detection 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. We aim to describe a novel study design that was used to generate regulatory-quality data to evaluate the serial use of Ag-RDT in detecting SARS-CoV-2 virus among asymptomatic individuals.
This prospective cohort study used a siteless, digital approach to assess longitudinal performance of Ag-RDT. Individuals over 2 years old from across the USA with no reported COVID-19 symptoms in the 14 days prior to study enrollment were eligible to enroll in this study. Participants throughout the mainland USA were enrolled through a digital platform between October 18, 2021 and February 15, 2022. Participants were asked to test using Ag-RDT and molecular comparators every 48 hours for 15 days. Enrollment demographics, geographic distribution, and SARS-CoV-2 infection rates are reported.
A total of 7361 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 US states, and geographic distribution of participants shifted in accordance with the changing COVID-19 prevalence nationwide.
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用于检测严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的快速抗原检测试验（Ag-RDT）通常包括一项授权条件，即评估该试验在连续使用时对无症状个体的检测性能。我们旨在描述一种新颖的研究设计，该设计用于生成具有监管质量的数据，以评估Ag-RDT在无症状个体中连续使用检测SARS-CoV-2病毒的情况。
这项前瞻性队列研究采用无现场、数字化方法评估Ag-RDT的纵向性能。在研究入组前14天内无新冠病毒病（COVID-19）症状报告的美国各地2岁以上个体有资格参加本研究。2021年10月18日至2022年2月15日期间，美国大陆的参与者通过一个数字平台入组。参与者被要求每48小时使用Ag-RDT和分子对照进行检测，共检测15天。报告了入组人口统计学信息、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，其中包括154名无症状且在研究开始时检测呈阴性的参与者。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，参与者的地理分布根据全国范围内不断变化的COVID-19流行情况而变化。
“在家检测我们”研究中采用的无现场数字化方法能够对COVID-19快速诊断进行快速、高效和严格的评估，并且可以跨研究学科进行调整，以优化研究入组和可及性。
