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]
Lemon, Stephenie C
Manabe, Yukari C
McManus, David D
UMass Chan AffiliationsCenter for Clinical and Translational Science
Microbiology and Physiological Systems
Morningside Graduate School of Biomedical Sciences
Population and Quantitative Health Sciences
Program in Molecular Medicine
Prevention Research Center
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AbstractBackground: 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.
SourceHerbert 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.
Permanent Link to this Itemhttp://hdl.handle.net/20.500.14038/51804
NotesThis article is a preprint. Preprints are preliminary reports of work that have not been certified by peer review.
Funding and AcknowledgementsThis 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).
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