Design and implementation of a digital site-less clinical study of serial rapid antigen testing to identify asymptomatic SARS-CoV-2 infection
What a decentralized diagnostic study can teach us about enrollment, follow-up and paired sample collection.
What the paper explores
The Test Us At Home study used digital recruitment and remote participation to evaluate repeated antigen testing. Participants completed antigen and molecular comparator testing on a defined schedule. The paper describes how a geographically distributed study could enroll participants during changing infection prevalence.
How to interpret the evidence
This is a study-design and implementation report. Operational feasibility does not by itself prove the performance of a new test, or guarantee that the same approach suits another population.
Questions for MedTech teams
Remote clinical operations still need clear instructions, sample logistics, traceable data and reliable follow-up. Treat these as parts of the evidence plan from the start.
Sources & further reading
Read original paperDOI: 10.1017/cts.2023.540
Bibliographic record and abstract on PubMedThis is a short editorial reading note on external research. The original research is attributed to its authors and does not represent an HMC study, product validation or regulatory determination.
