Abstract
Background: The performance of rapid antigen tests (Ag-RDTs) for screening asymptomatic and symptomatic persons for SARSCoV-2 is not well established. Objective: To evaluate the performance of Ag-RDTs for detection of SARS-CoV-2 among symptomatic and asymptomatic participants. Design: 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. Setting: 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. Participants: 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. Measurements: 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. Results: 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. Limitation: Participants tested every 48 hours; therefore, these data cannot support conclusions about serial testing intervals shorter than 48 hours. Conclusion: 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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 975-982 |
| Number of pages | 8 |
| Journal | Annals of internal medicine |
| Volume | 176 |
| Issue number | 7 |
| DOIs | |
| State | Published - Jul 2023 |
Funding
The authors thank their study participants; their collaborators from the NIH (National Institute of Biomedical Imaging and Bioengineering and National Heart, Lung, and Blood Institute), who provided scientific input into the design of this study and interpretation of the results but could not formally join as coauthors due to institutional policies; and the FDA (Office of In Vitro Diagnostics and Center for Devices and Radiological Health) for their involvement in the primary Test Us At Home study. The authors received meaningful contributions from Drs. Bruce Tromberg, Jill Heemskerk, Dennis Buxton, Felicia Qashu, Erin Iturriaga, Jue Chen, Andrew Weitz, and Krishna Juluru. They appreciate the contribution to this study by the numerous staff at University of Massachusetts Chan Medical School, including critical support from Karen Gilliam, Mary Janet McCarthy, Amber Showers, Cynthia Kinahan, Kimberly Cantin, and Danielle Howard. They also acknowledge the support provided by clinical coordinators from ThreeWire, and they thank county health departments across the country who helped with recruitment for this study by spreading the word in their networks. By the NIH RADx Tech program under grant 3U54HL143541-02S2 and NIH Clinical and Translational Science Award grant UL1TR001453. Grant Support: By the NIH RADx Tech program under grant 3U54HL143541-02S2 and NIH Clinical and Translational Science Award grant UL1TR001453.
ASJC Scopus subject areas
- Internal Medicine
