TY - JOUR
T1 - Performance of and Severe Acute Respiratory Syndrome Coronavirus 2 Diagnostics Based on Symptom Onset and Close Contact Exposure
T2 - An Analysis From the Test Us at Home Prospective Cohort Study
AU - Herbert, Carly
AU - Wang, Biqi
AU - Lin, Honghuang
AU - Yan, Yi
AU - Hafer, Nathaniel
AU - Pretz, Caitlin
AU - Stamegna, Pamela
AU - Wright, Colton
AU - Suvarna, Thejas
AU - Harman, Emma
AU - Schrader, Summer
AU - Nowak, Chris
AU - Kheterpal, Vik
AU - Orvek, Elizabeth
AU - Wong, Steven
AU - Zai, Adrian
AU - Barton, Bruce
AU - Gerber, Ben S.
AU - Lemon, Stephenie C.
AU - Filippaios, Andreas
AU - Gibson, Laura
AU - Greene, Sharone
AU - Colubri, Andres
AU - Achenbach, Chad
AU - Murphy, Robert
AU - Heetderks, William
AU - Manabe, Yukari C.
AU - O’Connor, Laurel
AU - Fahey, Nisha
AU - Luzuriaga, Katherine
AU - Broach, John
AU - Roth, Kristian
AU - McManus, David D.
AU - Soni, Apurv
N1 - Publisher Copyright:
© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.
PY - 2024/6/1
Y1 - 2024/6/1
N2 - Background. Understanding changes in diagnostic performance after symptom onset and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposure within different populations is crucial to guide the use of diagnostics for SARS-CoV-2. Methods. The Test Us at Home study was a longitudinal cohort study that enrolled individuals across the United States between October 2021 and February 2022. Participants performed paired antigen-detection rapid diagnostic tests (Ag-RDTs) and reverse-transcriptase polymerase chain reaction (RT-PCR) tests at home every 48 hours for 15 days and self-reported symptoms and known coronavirus disease 2019 exposures immediately before testing. The percent positivity for Ag-RDTs and RT-PCR tests was calculated each day after symptom onset and exposure and stratified by vaccination status, variant, age category, and sex. Results. The highest percent positivity occurred 2 days after symptom onset (RT-PCR, 91.2%; Ag-RDT, 71.1%) and 6 days after exposure (RT-PCR, 91.8%; Ag-RDT, 86.2%). RT-PCR and Ag-RDT performance did not differ by vaccination status, variant, age category, or sex. The percent positivity for Ag-RDTs was lower among exposed, asymptomatic than among symptomatic individuals (37.5% (95% confidence interval [CI], 13.7%–69.4%) vs 90.3% (75.1%–96.7%). Cumulatively, Ag-RDTs detected 84.9% (95% CI, 78.2%–89.8%) of infections within 4 days of symptom onset. For exposed participants, Ag-RDTs detected 94.0% (95% CI, 86.7%–97.4%) of RT-PCR–confirmed infections within 6 days of exposure. Conclusions. The percent positivity for Ag-RDTs and RT-PCR tests was highest 2 days after symptom onset and 6 days after exposure, and performance increased with serial testing. The percent positivity of Ag-RDTs was lowest among asymptomatic individuals but did not differ by sex, variant, vaccination status, or age category.
AB - Background. Understanding changes in diagnostic performance after symptom onset and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposure within different populations is crucial to guide the use of diagnostics for SARS-CoV-2. Methods. The Test Us at Home study was a longitudinal cohort study that enrolled individuals across the United States between October 2021 and February 2022. Participants performed paired antigen-detection rapid diagnostic tests (Ag-RDTs) and reverse-transcriptase polymerase chain reaction (RT-PCR) tests at home every 48 hours for 15 days and self-reported symptoms and known coronavirus disease 2019 exposures immediately before testing. The percent positivity for Ag-RDTs and RT-PCR tests was calculated each day after symptom onset and exposure and stratified by vaccination status, variant, age category, and sex. Results. The highest percent positivity occurred 2 days after symptom onset (RT-PCR, 91.2%; Ag-RDT, 71.1%) and 6 days after exposure (RT-PCR, 91.8%; Ag-RDT, 86.2%). RT-PCR and Ag-RDT performance did not differ by vaccination status, variant, age category, or sex. The percent positivity for Ag-RDTs was lower among exposed, asymptomatic than among symptomatic individuals (37.5% (95% confidence interval [CI], 13.7%–69.4%) vs 90.3% (75.1%–96.7%). Cumulatively, Ag-RDTs detected 84.9% (95% CI, 78.2%–89.8%) of infections within 4 days of symptom onset. For exposed participants, Ag-RDTs detected 94.0% (95% CI, 86.7%–97.4%) of RT-PCR–confirmed infections within 6 days of exposure. Conclusions. The percent positivity for Ag-RDTs and RT-PCR tests was highest 2 days after symptom onset and 6 days after exposure, and performance increased with serial testing. The percent positivity of Ag-RDTs was lowest among asymptomatic individuals but did not differ by sex, variant, vaccination status, or age category.
KW - COVID-19
KW - RT-PCR
KW - SARS-CoV-2
KW - SARS-CoV-2 variant
KW - rapid antigen test
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U2 - 10.1093/ofid/ofae304
DO - 10.1093/ofid/ofae304
M3 - Article
C2 - 38911947
AN - SCOPUS:85197607745
SN - 2328-8957
VL - 11
JO - Open Forum Infectious Diseases
JF - Open Forum Infectious Diseases
IS - 6
M1 - ofae304
ER -