Accepted for Publication: July 7, 2022.
Published: August 24, 2022. doi:10.1001/jamanetworkopen.2022.28143
Correction: This article was corrected on October 3, 2022, to fix Dr Hau’s academic degree in the byline.
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2022 Drain PK et al. JAMA Network Open.
Corresponding Author: Paul K. Drain, MD, MPH, University of Washington, 325 Ninth Ave, HMC# 359927, Seattle, WA 98104-2499 (pkdrain@uw.edu).
Author Contributions: Dr Drain had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Drain, Dalmat.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Drain, Dalmat, Uppal, Verma.
Critical revision of the manuscript for important intellectual content: Drain, Bemer, Morton, Dalmat, Abdille, Thomas, Hau, Green, Gates-Hollingworth, AuCoin, Verma.
Statistical analysis: Bemer, Dalmat, Thomas, Uppal.
Obtained funding: Drain, AuCoin.
Administrative, technical, or material support: Drain, Morton, Abdille, Hau, Green, Gates-Hollingworth.
Supervision: Drain, Morton, Abdille, Thomas, Hau, Gates-Hollingworth, AuCoin, Verma.
Conflict of Interest Disclosures: Dr Drain reported receiving grants from InBios International during the conduct of the study; research funding, paid to his institution, from the National Institutes of Health (NIH), the US Centers for Disease Control and Prevention (CDC), the Bill and Melinda Gates Foundation, Gilead Sciences, and Abbott; and consulting fees from Gilead Sciences, ThermoFisher, Cepheid, InBios International, Abbott, PATH, LumiraDx, and Alveo Technologies. Dr Uppal reported receiving financial support from InBioS LLC during the conduct of the study and outside the submitted work. Dr Hau reported receiving grants from the University of Nevada, Reno during the conduct of the study. Dr Gates-Hollingworth reported receiving grants from the University of Nevada, Reno during the conduct of the study. Dr AuCoin reported receiving fees from InBios International for a service contract to evaluate performance of the InBios SCoV-2 Ag Detect Rapid Self-Test during the conduct of the study; being the chief executive officer of a DxDiscovery Inc university startup pursuing development of a rapid diagnostic test for SARS-CoV-2; receiving grants from InBios International and the AuCoin laboratory; and having licensed technology from InBios International and the AuCoin laboratory for diagnosis of melioidosis outside the submitted work. No other disclosures were reported.
Funding/Support: The study was funded by InBios International Inc (Dr Drain).
Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Information: SARS-CoV-2 isolate USA-WA1/2020 was deposited by the CDC and obtained through BEI Resources, National Institute of Allergy and Infectious Diseases (NIAID), NIH: SARS-Related Coronavirus 2, NR-52281. The following reagents were obtained through BEI Resources, NIAID, NIH: SARS-Related Coronavirus 2, Isolate hCoV-19/USA/MD-HP05285/2021 (Lineage B.1.617.2; Delta Variant), and NR-55671, Isolate hCoV-19/USA/MD-HP20874/2021 (Lineage B.1.1.529; Omicron Variant), NR-56461, contributed by Andrew Pekosz, PhD (Johns Hopkins Bloomberg School of Public Health).
3.COVID-19 Excess Mortality Collaborators. Estimating excess mortality due to the COVID-19 pandemic: a systematic analysis of COVID-19-related mortality, 2020–21.
Lancet. 2022;399(10334):1513-1536. doi:
10.1016/S0140-6736(21)02796-3Crossref 4.World Health Organization. Technical Specifications for Selection of Essential In Vitro Diagnostics for SARS-CoV-2. World Health Organization; 2021.
7.Yadav
H , Shah
D , Sayed
S , Horton
S , Schroeder
LF . Availability of essential diagnostics in ten low-income and middle-income countries: results from national health facility surveys.
Lancet Glob Health. 2021;9(11):e1553-e1560. doi:
10.1016/S2214-109X(21)00442-3
PubMedGoogle ScholarCrossref 12.Lee
J , Song
JU , Shim
SR . Comparing the diagnostic accuracy of rapid antigen detection tests to real time polymerase chain reaction in the diagnosis of SARS-CoV-2 infection: a systematic review and meta-analysis.
J Clin Virol. 2021;144:104985. doi:
10.1016/j.jcv.2021.104985
PubMedGoogle ScholarCrossref 21.Bewley
KR , Coombes
NS , Gagnon
L ,
et al. Quantification of SARS-CoV-2 neutralizing antibody by wild-type plaque reduction neutralization, microneutralization and pseudotyped virus neutralization assays.
Nat Protoc. 2021;16(6):3114-3140. doi:
10.1038/s41596-021-00536-y
PubMedGoogle ScholarCrossref 23.Deerain
J , Druce
J , Tran
T ,
et al. Assessment of the analytical sensitivity of 10 lateral flow devices against the SARS-CoV-2 Omicron variant.
J Clin Microbiol. Published online December 22, 2021. doi:
10.1128/jcm.02479-21PubMedGoogle ScholarCrossref 24.Bekliz
M , Perez-Rodriguez
F , Puhach
O ,
et al. Sensitivity of SARS-CoV-2 antigen-detecting rapid tests for Omicron variant.
medRxiv. Preprint posted online January 17, 2022. doi:
10.1101/2021.12.18.21268018
25.Stanley
S , Hamel
DJ , Wolf
ID ,
et al. Limit of detection for rapid antigen testing of the SARS-CoV-2 Omicron variant.
medRxiv. Preprint posted online January 30, 2022. doi:
10.1101/2022.01.28.22269968
26.Schrom
J , Marquez
C , Pilarowski
G ,
et al. Direct comparison of SARS-CoV-2 nasal RT-PCR and rapid antigen
test (BinaxNOW™) at a community testing site during an Omicron surge.
medRxiv. Preprint posted online January 19, 2022. doi:
10.1101/2022.01.08.22268954Google Scholar 27.Currie
DW , Shah
MM , Salvatore
PP ,
et al; CDC COVID-19 Response Epidemiology Field Studies Team. Relationship of SARS-CoV-2 antigen and reverse transcription PCR positivity for viral cultures.
Emerg Infect Dis. 2022;28(3):717-720. doi:
10.3201/eid2803.211747
PubMedGoogle ScholarCrossref