Performance of Rapid Antigen Tests Based on Symptom Onset and Close Contact Exposure: A secondary analysis from the Test Us At Home prospective cohort study [preprint]
Authors
Herbert, CarlyWang, Biqi
Lin, Honghuang
Hafer, Nathaniel
Pretz, Caitlin
Stamegna, Pamela
Tarrant, Seanan
Hartin, Paul
Ferranto, Julia
Behar, Stephanie
Wright, Colton
Orwig, Taylor
Suvarna, Thejas
Harman, Emma
Schrader, Summer
Nowak, Chris
Kheterpal, Vik
Orvek, Elizabeth
Wong, Steven
Zai, Adrian
Barton, Bruce
Gerber, Ben
Lemon, Stephenie C
Filippaios, Andreas
D'Amore, Kylie
Gibson, Laura
Greene, Sharone
Howard-Wilson, Sakeina
Colubri, Andres
Achenbach, Chad
Murphy, Robert
Heetderks, William
Manabe, Yukari C
O'Connor, Laurel
Fahey, Nisha
Luzuriaga, Katherine
Broach, John
McManus, David D
Soni, Apurv
UMass Chan Affiliations
Center for Clinical and Translational ScienceEmergency Medicine
Medicine
Microbiology and Physiological Systems
Morningside Graduate School of Biomedical Sciences
Pediatrics
Population and Quantitative Health Sciences
Program in Molecular Medicine
Prevention Research Center
Document Type
PreprintPublication Date
2023-02-24
Metadata
Show full item recordAbstract
Background: The performance of rapid antigen tests for SARS-CoV-2 (Ag-RDT) in temporal relation to symptom onset or exposure is unknown, as is the impact of vaccination on this relationship. Objective: To evaluate the performance of Ag-RDT compared with RT-PCR based on day after symptom onset or exposure in order to decide on 'when to test'. Design setting and participants: The Test Us at Home study was a longitudinal cohort study that enrolled participants over 2 years old across the United States between October 18, 2021 and February 4, 2022. All participants were asked to conduct Ag-RDT and RT-PCR testing every 48 hours over a 15-day period. Participants with one or more symptoms during the study period were included in the Day Post Symptom Onset (DPSO) analyses, while those who reported a COVID-19 exposure were included in the Day Post Exposure (DPE) analysis. Exposure: Participants were asked to self-report any symptoms or known exposures to SARS-CoV-2 every 48-hours, immediately prior to conducting Ag-RDT and RT-PCR testing. The first day a participant reported one or more symptoms was termed DPSO 0, and the day of exposure was DPE 0. Vaccination status was self-reported. Main outcome and measures: Results of Ag-RDT were self-reported (positive, negative, or invalid) and RT-PCR results were analyzed by a central laboratory. Percent positivity of SARS-CoV-2 and sensitivity of Ag-RDT and RT-PCR by DPSO and DPE were stratified by vaccination status and calculated with 95% confidence intervals. Results: A total of 7,361 participants enrolled in the study. Among them, 2,086 (28.3%) and 546 (7.4%) participants were eligible for the DPSO and DPE analyses, respectively. Unvaccinated participants were nearly twice as likely to test positive for SARS-CoV-2 than vaccinated participants in event of symptoms (PCR+: 27.6% vs 10.1%) or exposure (PCR+: 43.8% vs. 22.2%). The highest proportion of vaccinated and unvaccinated individuals tested positive on DPSO 2 and DPE 5-8. Performance of RT-PCR and Ag-RDT did not differ by vaccination status. Ag-RDT detected 78.0% (95% Confidence Interval: 72.56-82.61) of PCR-confirmed infections by DPSO 4. For exposed participants, Ag-RDT detected 84.9% (95% CI: 75.0-91.4) of PCR-confirmed infections by day five post-exposure (DPE 5). Conclusions and relevance: Performance of Ag-RDT and RT-PCR was highest on DPSO 0-2 and DPE 5 and did not differ by vaccination status. These data suggests that serial testing remains integral to enhancing the performance of Ag-RDT.Source
Herbert C, Wang B, Lin H, Hafer N, Pretz C, Stamegna P, Tarrant S, Hartin P, Ferranto J, Behar S, Wright C, Orwig T, Suvarna T, Harman E, Schrader S, Nowak C, Kheterpal V, Orvek E, Wong S, Zai A, Barton B, Gerber B, Lemon SC, Filippaios A, D'Amore K, Gibson L, Greene S, Howard-Wilson S, Colubri A, Achenbach C, Murphy R, Heetderks W, Manabe YC, O'Connor L, Fahey N, Luzuriaga K, Broach J, McManus DD, Soni A. Performance of Rapid Antigen Tests Based on Symptom Onset and Close Contact Exposure: A secondary analysis from the Test Us At Home prospective cohort study. medRxiv [Preprint]. 2023 Feb 24:2023.02.21.23286239. doi: 10.1101/2023.02.21.23286239. PMID: 36865199; PMCID: PMC9980261.DOI
10.1101/2023.02.21.23286239Permanent Link to this Item
http://hdl.handle.net/20.500.14038/51804PubMed ID
36865199Notes
This article is a preprint. Preprints are preliminary reports of work that have not been certified by peer review.Funding and Acknowledgements
This study was funded by the NIH RADx Tech program under 3U54HL143541-02S2 and NIH CTSA grant UL1TR001453. The views expressed in this manuscript are those of the authors and do not necessarily represent the views of the National Institute of Biomedical Imaging and Bioengineering; the National Heart, Lung, and Blood Institute; the National Institutes of Health, or the U.S. Department of Health and Human Services. Salary support from the National Institutes of Health U54HL143541, R01HL141434, R01HL137794, R61HL158541, R01HL137734, U01HL146382 (AS, DDM), U01AG068221 (HL), U54EB007958-13 (YCM, MLR), AI272201400007C, UM1AI068613 (YCM), U54EB027049 and U54EB027049-02S1 (CJA, RLM).Rights
The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.ae974a485f413a2113503eed53cd6c53
10.1101/2023.02.21.23286239